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This study will gather preliminary clinical, health economic, and safety data on the treatment of chronic wounds with the ALLEVYN Life Non-Bordered dressing compared to standard of care treatment when used on a wound.
The study is a pilot RCT, which will generate the first comparative clinical, economic, and safety data for use of ALNB in subjects. A small sample of subjects with a range of chronic, moderate to highly exuding ulcer types (LU [arterial/mixed etiology leg ulcers or venous leg ulcers requiring compression therapy], PU, and non-ischemic DFU) will be enrolled and followed for 12 weeks to study the impact on health-related quality of life, ulcer progression and healthcare resource utilization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALLEVYN Life Non-Bordered | Experimental | Foam Dressing |
|
| Standard care | Other | Standard care dressing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALLEVYN Life Non-Bordered | Device | Foam Dressing |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Cardiff Wound Impact Schedule-Physical Symptoms of Daily Living (CWIS-PSDL) Scale Score From Baseline to the Week 6 Visit | The primary objective was to estimate the effect of treatment with ALLEVYN Life Non-Bordered (ALNB) on Health-Related Quality of Life (HRQoL) in subjects with chronic ulcers, measured using the CWIS-PSDL scale, compared to subjects receiving standard care (SC) alone over a 6-week treatment period. The CWIS is a questionnaire to measure the impact of chronic wounds on patient health-related quality of life and identify areas of patient concern. The CWIS-PSDL score is transformed on to a 0-100 scale, where a high score indicates a positive rating. The following calculation is used: CWIS-PSDL = (Sum of PSDL item scores-N_PSDL)/(N_PSDL "x" 4) ×100, where NPSDL = count of 24 questions completed (experience and stress) PSDL Sub-scores are based on 24 questions (12 items on the extent of the problem and 12 on the associated stress), each graded on a 5-point Likert scale [1-5]) with higher scores indicating a better outcome. | Baseline through 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks | Assessment of the change over time for the Cardiff Wound Impact Schedule-Physical Symptoms of Daily Living (CWIS-PSDL) Score at 3 and 12 weeks; CWIS-Well-Being (WB), CWIS-Social Life (SL), CWIS-Global Quality of Life (GQ), CWIS-Quality of Life Scales (SQ) at 3, 6, and 12 weeks. PSDL, SL, and WB sub-scores are based on 24 (score range 24-120), 14 (score range 14-70), and 7 (score range 7-35) questions, respectively; (each graded on a 5-point Likert scale [1-5]) Higher scores on all CWIS metrics indicate a better outcome. PSDL score = (sum of PSDL item scores - 24)/96 x 100 = calculated score of 0 to 100; e.g., 95-24/96 x 100 = 74 (of a possible 100) WB Score = (sum of WB item scores - 7)/28 x 100 = calculated score of 0 to 100 SL Score = (sum of SL item scores - 14)/56 x 100 = calculated score of 0 to 100 GQ Score = "How good is your quality of life" = score range 0 to 10 SQ Score = "How satisfied are you with your overall quality of life" = score range 0 to 10 |
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INCLUSION CRITERIA
The subject must provide informed consent to participate in the study.
The subject must be eighteen (18) years of age or older.
The subject must be willing and able to make all required study visits.
The subject must be able to follow instructions and be deemed capable of completing the CWIS questionnaire.
The subject must present with a chronic (≥ 4 weeks duration) ulcer which meets all of the following criteria:
The ulcer is classified as either:
The ulcer is, in the opinion of the Investigator, moderate to highly exuding.
The ulcer would, in the opinion of the Investigator, benefit from a protective dressing.
The ulcer is not infected based on clinical signs/symptoms.
A subject with a DFU must have an ankle-brachial index (ABI) of 0.7 or greater, as measured within 30 days of the Screening Visit.
EXCLUSION CRITERIA
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| Name | Affiliation | Role |
|---|---|---|
| Rachael Winter | Smith & Nephew, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Titan Clinical Solutions | Phoenix | Arizona | 85013 | United States | ||
| Center for Clinical Research |
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| ID | Title | Description |
|---|---|---|
| FG000 | ALLEVYN Life Non-Bordered | Foam Dressing ALLEVYN Life Non-Bordered: Foam Dressing |
| FG001 | Standard Care | Standard care dressing Standard Care: Foam Dressing |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ALLEVYN Life Non-Bordered | Foam Dressing ALLEVYN Life Non-Bordered: Foam Dressing |
| BG001 | Standard Care | Standard care dressing Standard Care: Foam Dressing |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in the Cardiff Wound Impact Schedule-Physical Symptoms of Daily Living (CWIS-PSDL) Scale Score From Baseline to the Week 6 Visit | The primary objective was to estimate the effect of treatment with ALLEVYN Life Non-Bordered (ALNB) on Health-Related Quality of Life (HRQoL) in subjects with chronic ulcers, measured using the CWIS-PSDL scale, compared to subjects receiving standard care (SC) alone over a 6-week treatment period. The CWIS is a questionnaire to measure the impact of chronic wounds on patient health-related quality of life and identify areas of patient concern. The CWIS-PSDL score is transformed on to a 0-100 scale, where a high score indicates a positive rating. The following calculation is used: CWIS-PSDL = (Sum of PSDL item scores-N_PSDL)/(N_PSDL "x" 4) ×100, where NPSDL = count of 24 questions completed (experience and stress) PSDL Sub-scores are based on 24 questions (12 items on the extent of the problem and 12 on the associated stress), each graded on a 5-point Likert scale [1-5]) with higher scores indicating a better outcome. | Scores were calculated for the full analysis set (FAS) population (all randomized subjects who received study treatment and attended at least 1 post-Baseline visit). | Posted | Mean | Standard Deviation | score on a scale | Baseline through 6 weeks |
Baseline through 12 weeks of treatment/End of Study Visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ALLEVYN Life Non-Bordered | Foam Dressing ALLEVYN Life Non-Bordered: Foam Dressing |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
A possible limitation of this study might include the broad nature of the standard of care treatment arm; such as, varying from dressing types to antimicrobial therapy used to NPWT, which may have made a standardized comparison to the ALLEVYN Life Non-Bordered dressing difficult to assess thoroughly. Due to the nature of the physical differences in the dressings it was not possible to blind either subjects or the clinicians.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Judith Horner | Smith & Nephew, Inc. | +44 1482 673251 | judith.horner@smith-nephew.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 27, 2017 | Sep 5, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 27, 2018 | Jan 31, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| D007871 | Leg Ulcer |
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D003925 | Diabetic Angiopathies |
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| Standard Care |
| Device |
Foam Dressing |
|
| PSDL: baseline, 3 and 12 weeks; WB, SL, GQ, and SQ: baseline, 3, 6, and 12 weeks |
| Ulcer Progression Using Modified Bates-Jensen Wound Assessment Tool (mBWAT) at Baseline, Weeks 3, 6, and 12 - Total Score | Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) for an overall wound score at each time point. The mBWAT score combined the sub-scores of mBWAT - a tool that has been in widespread use since the early 1990s. mBWAT scoring: There are 13 categories of assessment with item-level score range of 1 to 5 on a modified Likert scale. Each item is scored for the wound characteristic it describes where 1 indicates least severe and 5 indicates most severe with higher scores indicating a more severe wound status. Scores taken over a period of time can be used to track the progression of the wound healing process. Possible score range from 13 to 65 for the total score. The 13 sub-categories include: Size, depth, edges, undermining, necrotic tissue type, necrotic tissue amount, exudate type, exudate amount, skin color surrounding wound, peripheral tissue edema, peripheral tissue induration, granulation tissue, and epithelialization | Baseline, Weeks 3, 6, and 12 |
| Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the type of wound exudate exhibited at each time point. The tool defines the types of exudate as follows: Bloody = thin, bright red Serosanguinous = thin, watery, pale red to pink Serous = thin, watery, clear Purulent = thin or thick, opaque tan to yellow Foul purulent = thick, opaque yellow to green with offensive odor | Baseline, Weeks 3, 6, and 12 |
| Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the amount of wound exudate demonstrated at each time point. The tool gives the following category descriptions for amount of exudate: None = wound tissues dry Scant = wound tissues moist; no measurable exudate Small = wound tissues wet; moisture evenly distributed in wound; drainage involves </=25% dressing Moderate = wound tissues saturated; drainage may or may not be evenly distributed in wound; drainage involves >25% to </=75% dressing Large = wound tissues bathed in fluid; drainage freely expressed; may or may not be evenly distributed in wound; drainage involves >75% dressing The tool advises to use a transparent metric measuring guide with concentric circles divided into 4 pie-shaped quadrants to determine percentage of dressing involved with exudate. | Baseline, Weeks 3, 6, and 12 |
| Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the extent (measurement) of wound undermining at each time point. The tool guidance is as follows: Assess by inserting a cotton-tipped applicator under the wound edge; Advance it as far as it will go without using undue force; Raise the tip of the applicator so it may be seen or felt on the surface of the skin; Mark the surface with a pen; Measure the distance from the mark on the skin to the edge of the wound; Continue process around the wound; Then use a transparent metric measuring guide with concentric circles divided into 4 (25%) pie-shaped quadrants to help determine percent of wound involved. | Baseline, Weeks 3, 6, and 12 |
| Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for type (appearance) of necrotic tissue at each time point. The tool defines the categories of necrotic tissue type as follows: White/gray non-viable tissue = may appear prior to wound opening; skin surface is white or gray Non-adherent, yellow slough = thin, mucinous substance; scattered throughout wound bed; easily separated from wound tissue Loosely adherent, yellow slough = thick, stringy, clumps of debris; attached to wound tissue Adherent, soft, black eschar = soggy tissue; strongly attached to tissue in center or base of wound Firmly adherent, hard/black eschar = firm, crusty tissue; strongly attached to wound base and edges (like a hard scab) | Baseline, Weeks 3, 6, and 12 |
| Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the amount of necrotic tissue observed during dressing change at each time point. The tool guidance is to use a transparent metric measuring guide with concentric circles divided into 4 pie-shaped quadrants to help determine percent of wound involved. | Baseline, Weeks 3, 6, and 12 |
| Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the appearance of skin color changes surrounding the reference wound at each time point. The tool guidance is to assess tissues within 4 cm of wound edge. Dark-skinned persons show the colors "bright red" and "dark red" as a deepening of normal ethnic skin color or a purple hue. As healing occurs in dark-skinned persons, the new skin is pink and may never darken. | Baseline, Weeks 3, 6, and 12 |
| Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the appearance and percentage of granulation tissue in the reference wound at each time point. Granulation tissue is the growth of small blood vessels and connective tissue to fill in full-thickness wounds. Tissue is healthy when bright, beefy red, shiny, and granular with a velvety appearance. Poor vascular supply appears as pale-pink or blanched to dull, dusky red color. | Baseline, Weeks 3, 6, and 12 |
| Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the percentage of reference wound demonstrating epithelialization at each time point. Epithelialization is the process of epidermal resurfacing and appears as pink or red skin. In partial-thickness wounds, it can occur throughout the wound bed as well as from the wound edges. In full-thickness wounds, it occurs from the edges only. Use a transparent metric measuring guide with concentric circles divided into 4 (25%) pie-shaped quadrants to help determine percent of wound involved and to measure the distance the epithelial tissue extends into the wound. The mBWAT 13 categories include: Size, depth, edges, undermining, necrotic tissue type, necrotic tissue amount, exudate type, exudate amount, skin color surrounding wound, peripheral tissue edema, peripheral tissue induration, granulation tissue, and epithelialization. | Baseline, Weeks 3, 6, and 12 |
| Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Evaluation of the number of participants demonstrating peri-wound changes in appearance as determined visually by the Investigator; categorized as normal, erythematous, edematous, eczematous, excoriated, macerated, or indurated at each time point. | Baseline, Weeks 3, 6, and 12 |
| Ulcer Progression Assessed by Change From Baseline in Wound Area | The change from Baseline of the wound area was calculated to assess wound healing measured at each time point. Analyses were conducted using the last observation carried forward (LOCF) method to account for any missing follow-up visit data. A positive value indicated the wound showed an improvement in healing; a negative value indicated the wound showed worsening healing status based on wound area measurements. | Baseline, Weeks 3, 6 and 12 |
| Ulcer Progression Assessed by Change From Baseline in Wound Volume | The change from Baseline of the wound volume was calculated to assess wound healing measured at each time point. Analyses were conducted using the last observation carried forward (LOCF) method to account for any missing follow-up visit data. A positive value indicated the wound showed an improvement in healing; a negative value indicated the wound showed worsening healing status based on wound volume measurements. | Baseline, Weeks 3, 6, and 12 |
| Ulcer Progression Assessed by Change From Baseline in Wound Depth | The change from Baseline in the wound depth was calculated to assess wound healing measured at each time point. Analyses were conducted using the last observation carried forward (LOCF) method to account for any missing follow-up visit data. A positive value indicated the wound showed an improvement in healing; a negative value indicated the wound showed worsening healing status based on wound depth measurements. | Baseline, Weeks 3, 6, and 12 |
| Number of Participants With Reference Wound Healed | Assessment of the wound healed status (100% re-epithelialized, no drainage, no need for dressing) was analyzed at each visit to determine the healing status of the ulcer. Analyses were conducted using the last observation carried forward (LOCF) method to account for any missing follow-up visit data. | Weeks 3, 6 and 12 |
| Healthcare Resource Use Related to the Reference Ulcer Over 12 Weeks - Number of Dressings Used | Analysis of the healthcare resources used related to the reference ulcer included: Number of primary and secondary dressings including use of compression therapy. | Baseline through 12 weeks |
| Healthcare Resource Use Related to the Reference Ulcer - Type of Dressings Used Per Dressing Change | Analysis of the healthcare resources used related to the reference ulcer included: Type of primary and secondary dressings including compression therapy used during each dressing change over the 12-week treatment period based on the size of the ulcer. | Baseline through 12 weeks |
| Healthcare Resource Use - Number and Type of Compression Dressings Used | Not all enrolled participants required the use of compression dressings. Of those participants who did require a compression dressing, an analysis of the healthcare resources used included the number and type of primary and secondary dressings used in relation to the reference ulcer. | Baseline through 12 weeks |
| Healthcare Resource Use - Number of Participants Requiring Hospital Admission | Analysis of the healthcare resources used for participants who required a hospital admission related to the reference ulcer. | Baseline through 12 weeks |
| Healthcare Resource Use - Number of Days Participants Required In-Hospital Care | Analysis of the healthcare resources used related to the reference ulcer included: Time in hospital (number of days spent as an inpatient due to reference ulcer). | Baseline through 12 weeks |
| Healthcare Resource Use - Number of Dressing Changes Required for Each Type of Wound Debridement | Analysis of the healthcare resources used related to the reference ulcer included: Interventions/procedures related to the reference ulcer (number and type) including debridement of the ulcer. | Baseline through 12 weeks |
| Martinez |
| California |
| 94553 |
| United States |
| UCLA Medical Center | Sylmar | California | 91342 | United States |
| Grace Research Ltd. | Shreveport | Louisiana | 71105 | United States |
| Wound Care Plus, LLC | Summit | Missouri | 64086 | United States |
| JPS Health Network | Fort Worth | Texas | 76104 | United States |
| Adverse Event |
|
| Withdrawal by Subject |
|
| Noncompliance |
|
| Protocol Violation |
|
| Surgeon applied a graft with non-removable dressing; discharged to surgeon's care |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | inches |
|
| Weight | Mean | Standard Deviation | pounds |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Reference Wound Type | Count of Participants | Participants |
|
| Wound Duration | Mean | Standard Deviation | days |
|
| Wound Location | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | ALLEVYN Life Non-Bordered | Foam Dressing ALLEVYN Life Non-Bordered: Foam Dressing |
| OG001 | Standard Care | Standard care dressing Standard Care: Foam Dressing |
|
|
| Secondary | Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks | Assessment of the change over time for the Cardiff Wound Impact Schedule-Physical Symptoms of Daily Living (CWIS-PSDL) Score at 3 and 12 weeks; CWIS-Well-Being (WB), CWIS-Social Life (SL), CWIS-Global Quality of Life (GQ), CWIS-Quality of Life Scales (SQ) at 3, 6, and 12 weeks. PSDL, SL, and WB sub-scores are based on 24 (score range 24-120), 14 (score range 14-70), and 7 (score range 7-35) questions, respectively; (each graded on a 5-point Likert scale [1-5]) Higher scores on all CWIS metrics indicate a better outcome. PSDL score = (sum of PSDL item scores - 24)/96 x 100 = calculated score of 0 to 100; e.g., 95-24/96 x 100 = 74 (of a possible 100) WB Score = (sum of WB item scores - 7)/28 x 100 = calculated score of 0 to 100 SL Score = (sum of SL item scores - 14)/56 x 100 = calculated score of 0 to 100 GQ Score = "How good is your quality of life" = score range 0 to 10 SQ Score = "How satisfied are you with your overall quality of life" = score range 0 to 10 | Not all subjects participated in answering these questionnaire assessments. | Posted | Mean | Standard Deviation | score on a scale | PSDL: baseline, 3 and 12 weeks; WB, SL, GQ, and SQ: baseline, 3, 6, and 12 weeks |
|
|
|
| Secondary | Ulcer Progression Using Modified Bates-Jensen Wound Assessment Tool (mBWAT) at Baseline, Weeks 3, 6, and 12 - Total Score | Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) for an overall wound score at each time point. The mBWAT score combined the sub-scores of mBWAT - a tool that has been in widespread use since the early 1990s. mBWAT scoring: There are 13 categories of assessment with item-level score range of 1 to 5 on a modified Likert scale. Each item is scored for the wound characteristic it describes where 1 indicates least severe and 5 indicates most severe with higher scores indicating a more severe wound status. Scores taken over a period of time can be used to track the progression of the wound healing process. Possible score range from 13 to 65 for the total score. The 13 sub-categories include: Size, depth, edges, undermining, necrotic tissue type, necrotic tissue amount, exudate type, exudate amount, skin color surrounding wound, peripheral tissue edema, peripheral tissue induration, granulation tissue, and epithelialization | Not all subjects attended each scheduled visit and 2 subjects from the standard care group were withdrawn prior to receiving any treatment. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Weeks 3, 6, and 12 |
|
|
|
| Secondary | Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the type of wound exudate exhibited at each time point. The tool defines the types of exudate as follows: Bloody = thin, bright red Serosanguinous = thin, watery, pale red to pink Serous = thin, watery, clear Purulent = thin or thick, opaque tan to yellow Foul purulent = thick, opaque yellow to green with offensive odor | Not all subjects attended each scheduled visit and 2 subjects from the standard care group were withdrawn prior to receiving any treatment. | Posted | Count of Participants | Participants | Baseline, Weeks 3, 6, and 12 |
|
|
|
| Secondary | Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the amount of wound exudate demonstrated at each time point. The tool gives the following category descriptions for amount of exudate: None = wound tissues dry Scant = wound tissues moist; no measurable exudate Small = wound tissues wet; moisture evenly distributed in wound; drainage involves </=25% dressing Moderate = wound tissues saturated; drainage may or may not be evenly distributed in wound; drainage involves >25% to </=75% dressing Large = wound tissues bathed in fluid; drainage freely expressed; may or may not be evenly distributed in wound; drainage involves >75% dressing The tool advises to use a transparent metric measuring guide with concentric circles divided into 4 pie-shaped quadrants to determine percentage of dressing involved with exudate. | Not all subjects attended each scheduled visit and 2 subjects from the standard care group were withdrawn prior to receiving any treatment. | Posted | Count of Participants | Participants | Baseline, Weeks 3, 6, and 12 |
|
|
|
| Secondary | Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the extent (measurement) of wound undermining at each time point. The tool guidance is as follows: Assess by inserting a cotton-tipped applicator under the wound edge; Advance it as far as it will go without using undue force; Raise the tip of the applicator so it may be seen or felt on the surface of the skin; Mark the surface with a pen; Measure the distance from the mark on the skin to the edge of the wound; Continue process around the wound; Then use a transparent metric measuring guide with concentric circles divided into 4 (25%) pie-shaped quadrants to help determine percent of wound involved. | Not all subjects attended each scheduled visit and 2 subjects from the standard care group were withdrawn prior to receiving any treatment. | Posted | Count of Participants | Participants | Baseline, Weeks 3, 6, and 12 |
|
|
|
| Secondary | Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for type (appearance) of necrotic tissue at each time point. The tool defines the categories of necrotic tissue type as follows: White/gray non-viable tissue = may appear prior to wound opening; skin surface is white or gray Non-adherent, yellow slough = thin, mucinous substance; scattered throughout wound bed; easily separated from wound tissue Loosely adherent, yellow slough = thick, stringy, clumps of debris; attached to wound tissue Adherent, soft, black eschar = soggy tissue; strongly attached to tissue in center or base of wound Firmly adherent, hard/black eschar = firm, crusty tissue; strongly attached to wound base and edges (like a hard scab) | Not all subjects attended each scheduled visit and 2 subjects from the standard care group were withdrawn prior to receiving any treatment. | Posted | Count of Participants | Participants | Baseline, Weeks 3, 6, and 12 |
|
|
|
| Secondary | Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the amount of necrotic tissue observed during dressing change at each time point. The tool guidance is to use a transparent metric measuring guide with concentric circles divided into 4 pie-shaped quadrants to help determine percent of wound involved. | Not all subjects attended each scheduled visit and 2 subjects from the standard care group were withdrawn prior to receiving any treatment. | Posted | Count of Participants | Participants | Baseline, Weeks 3, 6, and 12 |
|
|
|
| Secondary | Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the appearance of skin color changes surrounding the reference wound at each time point. The tool guidance is to assess tissues within 4 cm of wound edge. Dark-skinned persons show the colors "bright red" and "dark red" as a deepening of normal ethnic skin color or a purple hue. As healing occurs in dark-skinned persons, the new skin is pink and may never darken. | Not all subjects attended each scheduled visit and 2 subjects from the standard care group were withdrawn prior to receiving any treatment. | Posted | Count of Participants | Participants | Baseline, Weeks 3, 6, and 12 |
|
|
|
| Secondary | Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the appearance and percentage of granulation tissue in the reference wound at each time point. Granulation tissue is the growth of small blood vessels and connective tissue to fill in full-thickness wounds. Tissue is healthy when bright, beefy red, shiny, and granular with a velvety appearance. Poor vascular supply appears as pale-pink or blanched to dull, dusky red color. | Not all subjects attended each scheduled visit and 2 subjects from the standard care group were withdrawn prior to receiving any treatment. | Posted | Count of Participants | Participants | Baseline, Weeks 3, 6, and 12 |
|
|
|
| Secondary | Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the percentage of reference wound demonstrating epithelialization at each time point. Epithelialization is the process of epidermal resurfacing and appears as pink or red skin. In partial-thickness wounds, it can occur throughout the wound bed as well as from the wound edges. In full-thickness wounds, it occurs from the edges only. Use a transparent metric measuring guide with concentric circles divided into 4 (25%) pie-shaped quadrants to help determine percent of wound involved and to measure the distance the epithelial tissue extends into the wound. The mBWAT 13 categories include: Size, depth, edges, undermining, necrotic tissue type, necrotic tissue amount, exudate type, exudate amount, skin color surrounding wound, peripheral tissue edema, peripheral tissue induration, granulation tissue, and epithelialization. | Not all subjects attended each scheduled visit and 2 subjects from the standard care group were withdrawn prior to receiving any treatment. | Posted | Count of Participants | Participants | Baseline, Weeks 3, 6, and 12 |
|
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|
| Secondary | Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Evaluation of the number of participants demonstrating peri-wound changes in appearance as determined visually by the Investigator; categorized as normal, erythematous, edematous, eczematous, excoriated, macerated, or indurated at each time point. | Not all subjects attended each scheduled visit and 2 subjects from the standard care group were withdrawn prior to receiving any treatment. | Posted | Count of Participants | Participants | Baseline, Weeks 3, 6, and 12 |
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| Secondary | Ulcer Progression Assessed by Change From Baseline in Wound Area | The change from Baseline of the wound area was calculated to assess wound healing measured at each time point. Analyses were conducted using the last observation carried forward (LOCF) method to account for any missing follow-up visit data. A positive value indicated the wound showed an improvement in healing; a negative value indicated the wound showed worsening healing status based on wound area measurements. | Not all subjects attended each scheduled visit and 2 subjects from the standard care group were withdrawn prior to receiving any treatment. | Posted | Mean | Standard Deviation | cm^2 | Baseline, Weeks 3, 6 and 12 |
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| Secondary | Ulcer Progression Assessed by Change From Baseline in Wound Volume | The change from Baseline of the wound volume was calculated to assess wound healing measured at each time point. Analyses were conducted using the last observation carried forward (LOCF) method to account for any missing follow-up visit data. A positive value indicated the wound showed an improvement in healing; a negative value indicated the wound showed worsening healing status based on wound volume measurements. | Not all subjects attended each scheduled visit and 2 subjects from the standard care group were withdrawn prior to receiving any treatment. | Posted | Mean | Standard Deviation | cm^3 | Baseline, Weeks 3, 6, and 12 |
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| Secondary | Ulcer Progression Assessed by Change From Baseline in Wound Depth | The change from Baseline in the wound depth was calculated to assess wound healing measured at each time point. Analyses were conducted using the last observation carried forward (LOCF) method to account for any missing follow-up visit data. A positive value indicated the wound showed an improvement in healing; a negative value indicated the wound showed worsening healing status based on wound depth measurements. | Not all subjects attended each scheduled visit and 2 subjects from the standard care group were withdrawn prior to receiving any treatment. | Posted | Mean | Standard Deviation | mm | Baseline, Weeks 3, 6, and 12 |
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| Secondary | Number of Participants With Reference Wound Healed | Assessment of the wound healed status (100% re-epithelialized, no drainage, no need for dressing) was analyzed at each visit to determine the healing status of the ulcer. Analyses were conducted using the last observation carried forward (LOCF) method to account for any missing follow-up visit data. | Not all subjects attended each scheduled visit and 2 subjects from the standard care group were withdrawn prior to receiving any treatment. | Posted | Count of Participants | Participants | Weeks 3, 6 and 12 |
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| Secondary | Healthcare Resource Use Related to the Reference Ulcer Over 12 Weeks - Number of Dressings Used | Analysis of the healthcare resources used related to the reference ulcer included: Number of primary and secondary dressings including use of compression therapy. | Two subjects in the standard care group withdrew prior to receiving treatment. | Posted | Mean | Standard Deviation | dressings used/participant | Baseline through 12 weeks |
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| Secondary | Healthcare Resource Use Related to the Reference Ulcer - Type of Dressings Used Per Dressing Change | Analysis of the healthcare resources used related to the reference ulcer included: Type of primary and secondary dressings including compression therapy used during each dressing change over the 12-week treatment period based on the size of the ulcer. | Not all subjects attended each scheduled visit and 2 subjects from the standard care group were withdrawn prior to receiving any treatment. | Posted | Mean | Standard Deviation | Dressings used per change | Baseline through 12 weeks | Dressings used per change | Dressings used per change |
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| Secondary | Healthcare Resource Use - Number and Type of Compression Dressings Used | Not all enrolled participants required the use of compression dressings. Of those participants who did require a compression dressing, an analysis of the healthcare resources used included the number and type of primary and secondary dressings used in relation to the reference ulcer. | Two subjects from the standard care group withdrew prior to receiving treatment. | Posted | Count of Units | Wounds | Baseline through 12 weeks | Wounds | Wounds |
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| Secondary | Healthcare Resource Use - Number of Participants Requiring Hospital Admission | Analysis of the healthcare resources used for participants who required a hospital admission related to the reference ulcer. | Two subjects from the standard care group withdrew prior to receiving treatment. | Posted | Count of Participants | Participants | Baseline through 12 weeks |
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| Secondary | Healthcare Resource Use - Number of Days Participants Required In-Hospital Care | Analysis of the healthcare resources used related to the reference ulcer included: Time in hospital (number of days spent as an inpatient due to reference ulcer). | Two subjects from the standard care group withdrew prior to receiving treatment. | Posted | Number | Days | Baseline through 12 weeks |
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| Secondary | Healthcare Resource Use - Number of Dressing Changes Required for Each Type of Wound Debridement | Analysis of the healthcare resources used related to the reference ulcer included: Interventions/procedures related to the reference ulcer (number and type) including debridement of the ulcer. | Two subjects from the standard care group withdrew prior to receiving treatment. | Posted | Count of Units | Dressing changes | Baseline through 12 weeks | Dressing changes | Dressing changes |
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|
|
| 0 |
| 25 |
| 1 |
| 25 |
| 3 |
| 25 |
| EG001 | Standard Care | Standard care dressing Standard Care: Foam Dressing | 0 | 15 | 3 | 15 | 2 | 15 |
| Pneumonia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Osteomyelitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Hip fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
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| Wound infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
Not provided
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| CWIS-WB Score Change at 3 Weeks |
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| CWIS-WB Score Change at 6 Weeks |
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| CWIS-WB Score Change at 12 Weeks |
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| CWIS-SL Score Change at 3 Weeks |
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| CWIS-SL Score Change at 6 Weeks |
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| CWIS-SL Score Change at 12 Weeks |
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| CWIS-GQ Change at 3 Weeks |
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| CWIS-GQ Change at 6 Weeks |
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| CWIS-GQ Change at 12 Weeks |
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| CWIS-SQ Change at 3 Weeks |
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| CWIS-SQ Change at 6 Weeks |
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| CWIS-SQ Change at 12 Weeks |
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| Week 3 Score |
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| Week 6 Score |
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| Week 12 Score |
|
|
| Bloody |
|
| Serosanguineous |
|
| Serous |
|
| Purulent |
|
| Week 3 |
|
|
| Week 6 |
|
|
| Week 12 |
|
|
| Scant, wound, moist but no observable exudate |
|
| Small |
|
| Moderate |
|
| Large |
|
| Week 3 |
|
|
| Week 6 |
|
|
| Week 12 |
|
|
| <2 cm in any area |
|
| 2-4 cm involving <50% wound margins |
|
| 2-4 cm involving >50% wound margins |
|
| >4 cm or tunnelling in any area |
|
| Week 3 |
|
|
| Week 6 |
|
|
| Week 12 |
|
|
| White/grey nonviable tissue and/or nonadherent yellow slough |
|
| Loosely adherent yellow slough |
|
| Adherent, soft, black eschar |
|
| Firmly adherent, hard, black eschar |
|
| Week 3 |
|
|
| Week 6 |
|
|
| Week 12 |
|
|
| <25% of wound bed covered |
|
| 25% to 50% of wound covered |
|
| >50% to <75% of wound covered |
|
| >75% to 100% of wound covered |
|
| Week 3 |
|
|
| Week 6 |
|
|
| Week 12 |
|
|
| Bright red and/or blanches to touch |
|
| White or grey pallor or hypopigmented |
|
| Dark red/ or purple and/or nonblanchable |
|
| Black or hyperpigmented |
|
| Week 3 |
|
|
| Week 6 |
|
|
| Week 12 |
|
|
| Bright, beefy red; 75-100% wound filled/ or tissue overgrowth |
|
| Bright, beefy red; <75% & >25% wound filled |
|
| Pink and/or dull, dusky red and/or fills ≤25% of wound |
|
| No granulation tissue present |
|
| Week 3 |
|
|
| Week 6 |
|
|
| Week 12 |
|
|
| 75% - <100% wound covered and/or epithelial tissue extends >0.5 cm into wound bed |
|
| 50% - <75% wound covered and/or epithelial tissue extends <0.5 cm into wound bed |
|
| 25% - <50% wound covered |
|
| <25% wound covered |
|
| Week 3 |
|
|
| Week 6 |
|
|
| Week 12 |
|
|
| Erythematous |
|
| Edematous |
|
| Eczematous |
|
| Excoriated |
|
| Macerated |
|
| Indurated |
|
| Week 3 |
|
|
| Week 6 |
|
|
| Week 12 |
|
|
| Week 3, wound area |
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|
| Week 3, change in wound area |
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|
| Week 6, wound area |
|
|
| Week 6, change in wound area |
|
|
| Week 12, wound area |
|
|
| Week 12, change in wound area |
|
|
| Week 3, wound volume |
|
|
| Week 3, change in wound volume |
|
|
| Week 6, wound volume |
|
|
| Week 6, change in wound volume |
|
|
| Week 12, wound volume |
|
|
| Week 12, change in wound volume |
|
|
| Week 3, wound depth |
|
|
| Week 3, change in wound depth |
|
|
| Week 6, wound depth |
|
|
| Week 6, change in wound depth |
|
|
| Week 12, wound depth |
|
|
| Week 12, change in wound depth |
|
|
| Yes |
|
| Week 6, reference ulcer healed |
|
|
| Week 12, reference ulcer healed |
|
|
|
| ALNB, 16 x 16 cm |
|
|
| ALNB, 10 x 20 cm |
|
|
| Standard care |
|
|
| Multi layer inelastic |
|
| Single layer elastic |
|
| Single layer inelastic |
|
| Support hosiery |
|
| Other |
|
| Compression dressing application not required |
|
| Scalpel debridement |
|
| Forceps debridement |
|
| Other type of debridement |
|
| Wound debridement not required as part of care |
|