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A prospective, randomized, controlled clinical trial (RCT) using a cross-over (repeated measures) design to evaluate safety and efficacy of three foam wound dressings in the local management of chronic wounds.
The study will be conducted in an outpatient setting of an academic clinical center over a total period of four weeks (28 days, -1/+2).
The aim of this RCT is to evaluate and compare three different foam dressings in the local management of chronic wounds (i.e. venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs)) in an outpatient setting. A bordered, five-layer, flexible foam dressing with soft silicone adhesive technology will be evaluated versus a hydropolymer, adhesive foam island dressing and a multi-layered, hydrocellular foam dressing with silicone adhesive, within three focus areas; efficacy and safety of the dressings, participant-centric outcomes and health economic evaluation.
Note: The terms used within the body of this report and results, in both the Primary and Secondary Outcomes, are defined as follows:
Period 1: Weeks 1 and 2 of study follow-up visits. Period 2: Weeks 3 and 4 of study follow-up visits. Week 1: Designates data captured only on visit days 7 and 21. Week 2: Designates data captured only on visit days 14 and 28. During Week 1: Designates data captured on visit days 3, 7, 17 and 21. During Week 2: Designates data captured on visit days 10, 14, 24 and 28. Day 3 of Week 1 from tables: inclusive of data captured on Visit Days 3 and 17. Day 3 of Week 2 from tables: inclusive of data captured on Visit Days 10 and 24.
Day 7 of Week 1 from tables: inclusive of data captured on Visit Days 7 and 21. Day 7 of Week 2 from tables: inclusive of data captured on Visit Days 14 and 28.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Five-layer vs Hydropolymer | Active Comparator | Bordered Five-layer Foam Dressing for 2 weeks, followed by Hydropolymer Foam Dressing for 2 weeks. |
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| Hydropolymer vs Five-layer | Active Comparator | Hydropolymer Foam Dressing for 2 weeks, followed by Bordered Five-layer Foam Dressing for 2 weeks |
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| Five-layer vs Hydrocellular | Active Comparator | Bordered Five-layer Foam Dressing for 2 weeks, followed by Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks. |
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| Hydrocellular vs Five-layer | Active Comparator | Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks, followed by Bordered Five-layer Foam Dressing for 2 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bordered Five-Layer Foam Dressing | Device | Bordered, five-layer, flexible foam dressing with soft silicone adhesive technology |
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| Measure | Description | Time Frame |
|---|---|---|
| % of Participants With Equal or Better Rate of Dressing Durability | Dressing strike-through determined @ Wk1 Day 3&7, and Wk3 Day 17&21. Dressing strike-through that occurred Day 3 and/or 7, Day 17 and/or 21 were included in final dataset. Contributing factors to strike-through: Saturation of dressing pad:
Dislodgement of dressing:
Dressing design deficiency:
| 4 weeks |
| % of Participants With No Strike-through After 7 Days Wear Time at Day 7 and 21 | Intact dressing after 7 days wear time, assessed @ Wk1 Day7 & Wk3 Day21 only. 1st week of dressing wear (Wks 1 & 3) is critical for start of wound healing. Contributing factors to strike-through: Saturation of dressing pad:
Dislodgement of dressing:
Dressing design deficiency:
| Weeks 1 and 3 |
| Measure | Description | Time Frame |
|---|---|---|
| % of Participants With Equal or Better Outcomes on Local Wound and Skin Pain Before Dressing Removal With Five-layer | Pain was measured by subjects' responses to Visual Analogue Scale (VAS) of 0-10 at intervals of 2, 0=no pain, 10=worst pain ever. | 4 weeks |
| % of Participants With Equal or Better Outcomes on Local Wound and Skin Pain at Removal With Five-layer |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oscar Alvarez | Vascular and Wound Care Center, University Hospital, Newark, NJ, USA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Clinical Research, Inc. | Castro Valley | California | 94546 | United States | ||
| Center for Clinical Trials, Inc. |
40 participants were randomized and received treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hydropolymer vs Five-layer | Hydropolymer Foam Dressing for 2 weeks, then Bordered Five-Layer Foam Dressing for 2 weeks |
| FG001 | Five-layer vs Hydropolymer | Bordered Five-Layer Foam Dressing for 2 weeks, then Hydropolymer Foam Dressing for 2 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 15, 2019 |
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This is a prospective RCT using a crossover design to evaluate safety and efficacy. The study will be conducted in an outpatient setting of an academic clinical center. There will be two participant groups: those with VLU and those with DFU. Approximately 50% of the participants will be in the VLU group and 50% of the participants in the DFU group. Treatment sequence will be randomized so that a fair distribution is achieved. Each participant will receive a 2-week treatment with one of the three dressings followed by a 2-week treatment period with a second dressing (i.e. each participant will receive treatment with two different dressings, either the Bordered Five-Layer Foam Dressing and the Hydropolymer Foam Dressing, or the Bordered Five-Layer Foam Dressing and the Hydrocellular Multi-Layer Foam Dressing) using a cross-over (repeated measures) design, with a total of four study arms.
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| Hydropolymer Foam Dressing | Device | Hydropolymer, adhesive foam island dressing |
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| Hydrocellular Multi-Layer Foam Dressing | Device | Multi-layered, hydrocellular foam dressing with silicone adhesive |
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Pain was measured by subjects' responses to Visual Analogue Scale (VAS) of 0-10 at intervals of 2, 0=no pain, 10=worst pain ever. |
| 4 weeks |
| % of Participants With Equal or Better Outcomes on Local Wound and Skin Pain Immediately After Dressing Removal With Five-layer | Pain was measured by subjects' responses to Visual Analogue Scale (VAS) of 0-10 at intervals of 2, 0=no pain, 10=worst pain ever. | 4 weeks |
| % of Participants With Equal or Better Outcomes With Five-layer in Evaluation of the Dressings | Dressing evaluation was determined via visual observation by study clinicians and categorized by saturation level: Partly saturated, Mostly saturated, and Strike-through. | 4 weeks |
| % of Participants With Equal or Better Outcomes With Five-Layer When Assessing Wound Granulation | Wound granulation was measured by visual assessment and photodigital planimetry. Wound granulation were grouped into 6 categories: None, <25%, 25-49%, 50-74%, 75-99%, 100%. | 4 weeks |
| % of Participants With Equal or Better Outcomes With Five-Layer When Assessing Wounds for Non-viable Tissue (Eschar, Fibrin Slough, Both) | Non-viable tissue was determined by visual assessment and photodigital planimetry. Non-viable tissues were grouped into 5 categories: None, <25%, 25-49%, 50-74%, 75-100%. | 4 weeks |
| Mean Difference in Score in SF12 Health-Related Quality-of-Life Questionnaire | The SF-12 health survey consists of 12 questions that yield an eight-scale profile of functional health and well-being, and 2 component summary measures of physical and mental health. SF-12 scores range from 0 to 100 with lower scores indicate lower levels of health. SF-12 questionnaire was administered at Screening/Baseline, Day 14, and Day 28 visits, and scored by a 3rd party vendor. Results are mean differences between five-layer vs the comparator dressing and presented for each of the 8 health domains, and 2 component summary measures. Negative scores indicate lower SF-12 scores (indicating lower levels of health) for the five-layer treatment group; positive scores indicate higher SF-12 scores for the five-layer group. | 4 weeks |
| San Francisco |
| California |
| 94115 |
| United States |
| Vascular and Wound Care Center | Newark | New Jersey | 07101 | United States |
| SerenaGroup Research Foundation | Pittsburgh | Pennsylvania | 15222 | United States |
| SerenaGroup | Pittsburgh | Pennsylvania | 15232 | United States |
| FG002 | Hydrocellular vs Five-layer | Hydrocellular Multi-Layer Foam Dressing for 2 weeks then Bordered Five-Layer Foam Dressing for weeks |
| FG003 | Five-layer vs Hydrocellular | Bordered Five-Layer Foam Dressing for two weeks then Hydrocellular Multi-Layer Foam Dressing for two weeks |
| COMPLETED |
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| NOT COMPLETED |
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Intent-to-treat population
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| ID | Title | Description |
|---|---|---|
| BG000 | Hydropolymer vs Five-layer | Hydropolymer Foam Dressing for 2 weeks, then Bordered Five-Layer Foam Dressing for 2 weeks |
| BG001 | Five-layer vs Hydropolymer | Bordered Five-Layer Foam Dressing for 2 weeks, then Hydropolymer Foam Dressing for 2 weeks |
| BG002 | Hydrocellular vs Five-layer | Hydrocellular Multi-Layer Foam Dressing for 2 weeks then Bordered Five-Layer Foam Dressing for weeks |
| BG003 | Five-layer vs Hydrocellular | Bordered Five-Layer Foam Dressing for two weeks then Hydrocellular Multi-Layer Foam Dressing for two weeks |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | % of Participants With Equal or Better Rate of Dressing Durability | Dressing strike-through determined @ Wk1 Day 3&7, and Wk3 Day 17&21. Dressing strike-through that occurred Day 3 and/or 7, Day 17 and/or 21 were included in final dataset. Contributing factors to strike-through: Saturation of dressing pad:
Dislodgement of dressing:
Dressing design deficiency:
| Intent-to-treat (ITT) analysis set of superiority. Participants were combined into 2 cohorts: participants in the Five-layer vs Hydropolymer into one cohort, & Five-layer vs Hydrocellular were similarly combined into a second cohort to allow for reporting and analysis in order to compare # of incidences of strike-through when participants received one dressing or the other first for the 4 week treatment phase. Number of participants analyzed differ from baseline due to missing values. | Posted | Number | %participants | 4 weeks |
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| Primary | % of Participants With No Strike-through After 7 Days Wear Time at Day 7 and 21 | Intact dressing after 7 days wear time, assessed @ Wk1 Day7 & Wk3 Day21 only. 1st week of dressing wear (Wks 1 & 3) is critical for start of wound healing. Contributing factors to strike-through: Saturation of dressing pad:
Dislodgement of dressing:
Dressing design deficiency:
| Intent-to-treat (ITT) analysis set of superiority. Participants were combined into 2 cohorts: participants in the Five-layer vs Hydropolymer into one cohort, & Five-layer vs Hydrocellular were similarly combined into a second cohort to allow for reporting and analysis in order to compare # of incidences of strike-through when participants received one dressing or the other first for the 4 week treatment phase. Number of participants analyzed differ from baseline due to missing values. | Posted | Number | %participants | Weeks 1 and 3 |
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| Secondary | % of Participants With Equal or Better Outcomes on Local Wound and Skin Pain Before Dressing Removal With Five-layer | Pain was measured by subjects' responses to Visual Analogue Scale (VAS) of 0-10 at intervals of 2, 0=no pain, 10=worst pain ever. | Intent-to-treat (ITT) analysis set of superiority. Participants were combined into 2 cohorts: participants in the Five-layer vs Hydropolymer into one cohort, & Five-layer vs Hydrocellular were similarly combined into a second cohort to allow for reporting and analysis in order to compare level of local wound and skin pain among participants who received one dressing or the other first for the 4 week treatment phase. Number of participants analyzed differ from baseline due to missing values. | Posted | Number | %participants | 4 weeks |
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| Secondary | % of Participants With Equal or Better Outcomes on Local Wound and Skin Pain at Removal With Five-layer | Pain was measured by subjects' responses to Visual Analogue Scale (VAS) of 0-10 at intervals of 2, 0=no pain, 10=worst pain ever. | Intent-to-treat (ITT) analysis set of superiority. Participants were combined into 2 cohorts: participants in the Five-layer vs Hydropolymer into one cohort, & Five-layer vs Hydrocellular were similarly combined into a second cohort to allow for reporting & analysis in order to compare level of local wound and skin pain among participants who received one dressing or the other first for the 4 week treatment phase. Number of participants analyzed differ from baseline due to missing values. | Posted | Number | %participants | 4 weeks |
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| Secondary | % of Participants With Equal or Better Outcomes on Local Wound and Skin Pain Immediately After Dressing Removal With Five-layer | Pain was measured by subjects' responses to Visual Analogue Scale (VAS) of 0-10 at intervals of 2, 0=no pain, 10=worst pain ever. | Intent-to-treat (ITT) analysis set of superiority. Participants were combined into 2 cohorts: participants in the Five-layer vs Hydropolymer into one cohort, & Five-layer vs Hydrocellular were similarly combined into a second cohort to allow for reporting & analysis in order to compare level of local wound and skin pain among participants who received one dressing or the other first for the 4 week treatment phase. Number of participants analyzed differ from baseline due to missing values. | Posted | Number | %participants | 4 weeks |
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| Secondary | % of Participants With Equal or Better Outcomes With Five-layer in Evaluation of the Dressings | Dressing evaluation was determined via visual observation by study clinicians and categorized by saturation level: Partly saturated, Mostly saturated, and Strike-through. | Intent-to-treat (ITT) analysis set of superiority. Participants were combined into 2 cohorts: participants in Five-layer vs Hydropolymer into one cohort, & Five-layer vs Hydrocellular were similarly combined into a second cohort to allow for reporting & analysis in order to compare level of saturation in the dressings among participants who received one dressing or the other first for the 4 week treatment phase. Number of participants analyzed differ from baseline due to missing values. | Posted | Number | %participants | 4 weeks |
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| Secondary | % of Participants With Equal or Better Outcomes With Five-Layer When Assessing Wound Granulation | Wound granulation was measured by visual assessment and photodigital planimetry. Wound granulation were grouped into 6 categories: None, <25%, 25-49%, 50-74%, 75-99%, 100%. | Intent-to-treat (ITT) analysis set of superiority. Participants were combined into 2 cohorts: participants in the Five-layer vs Hydropolymer into one cohort, & Five-layer vs Hydrocellular were similarly combined into a second cohort to allow for reporting & analysis in order to compare level of wound granulation among participants who received one dressing or the other first for the 4 week treatment phase. Number of participants analyzed differ from baseline due to missing values. | Posted | Number | %participants | 4 weeks |
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| Secondary | % of Participants With Equal or Better Outcomes With Five-Layer When Assessing Wounds for Non-viable Tissue (Eschar, Fibrin Slough, Both) | Non-viable tissue was determined by visual assessment and photodigital planimetry. Non-viable tissues were grouped into 5 categories: None, <25%, 25-49%, 50-74%, 75-100%. | Intent-to-treat (ITT) analysis set of superiority. Participants were combined into 2 cohorts: participants in Five-layer vs Hydropolymer into one cohort, & Five-layer vs Hydrocellular were similarly combined into a second cohort to allow for reporting & analysis to compare the amount of non-viable tissue in the wound among participants who received one dressing or the other first for the 4 week treatment phase. Number of participants analyzed differ from baseline due to missing values. | Posted | Number | %participants | 4 weeks |
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| Secondary | Mean Difference in Score in SF12 Health-Related Quality-of-Life Questionnaire | The SF-12 health survey consists of 12 questions that yield an eight-scale profile of functional health and well-being, and 2 component summary measures of physical and mental health. SF-12 scores range from 0 to 100 with lower scores indicate lower levels of health. SF-12 questionnaire was administered at Screening/Baseline, Day 14, and Day 28 visits, and scored by a 3rd party vendor. Results are mean differences between five-layer vs the comparator dressing and presented for each of the 8 health domains, and 2 component summary measures. Negative scores indicate lower SF-12 scores (indicating lower levels of health) for the five-layer treatment group; positive scores indicate higher SF-12 scores for the five-layer group. | ITT analysis set. Means and standard deviations represent participants' responses from follow-up visits aggregated. Participants were combined into 2 cohorts: participants in the Five-layer vs Hydropolymer into one cohort, & Five-layer vs Hydrocellular were similarly combined into a second cohort to allow for reporting & analysis in order to compare health-related quality-of-life when using each type of dressing. Number of participants analyzed differ from baseline due to missing values. | Posted | Mean | Standard Deviation | score on a scale | 4 weeks |
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| Post-Hoc | % Participant Compliance in Wear Time Between Five-layer and Comparator Dressing | Compliance with the 7-day wear time protocol, within the first critical week of treatment. Compliance is defined as participants who wore a dressing continuously from time of application until removal at Day 7 visit. This includes participants whose dressing did not have strikethrough up to Day 7 and those who wore their dressing until strikethrough at Day 7 when dressing was removed. | Intent-to-treat (ITT) analysis set of superiority. Participants were combined into 2 cohorts: participants in the Five-layer vs Hydropolymer into one cohort, & Five-layer vs Hydrocellular were similarly combined into a second cohort to allow for reporting and analysis in order to compare the % of participant in compliance with 7-day wear time protocol in the first week of treatment. Number of participants analyzed differ from baseline due to missing values. | Posted | Number | %participant | 1 week |
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Two weeks for each intervention.
Safety population included all participants who received at least one dressing.
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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 | Hydropolymer, Then Five-layer | Hydropolymer Foam Dressing for 2 weeks, followed by Bordered Five-layer Foam Dressing for 2 weeks | 1 | 11 | 0 | 11 | 1 | 11 |
| EG001 | Five-layer, Then Hydropolymer | Bordered Five-layer Foam Dressing for 2 weeks, followed by Hydropolymer Foam Dressing for 2 weeks | 4 | 9 | 0 | 9 | 4 | 9 |
| EG002 | Hydrocellular, Then Five-layer | Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks followed by Bordered Five-layer Foam Dressing for 2 weeks | 0 | 11 | 0 | 11 | 0 | 11 |
| EG003 | Five-layer, Then Hydrocellular | Bordered Five-layer Foam Dressing for 2 weeks, followed by Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks | 1 | 9 | 0 | 9 | 1 | 9 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blister plantar midfoot | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pain due to compression | General disorders | Systematic Assessment |
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| Increased pain to study limb | General disorders | Systematic Assessment |
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| Infection to study ulcer | Infections and infestations | Systematic Assessment |
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| Blister left plantar forefoot | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Pham | Molnlycke Health Care | 678-231-9655 | david.pham@molnlycke.com |
| Sep 4, 2020 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D003925 | Diabetic Angiopathies |
| D016523 | Foot Ulcer |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
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All data presented on the performance of the dressings reflect the FAS populations for the study comparison groups.
| Chi-squared | 0.56 | Five-layer vs Hydrocellular arm; Weeks 2 & 4 | Superiority | In this superiority study the primary efficacy analysis included constructing a two sided 5% significance level, using Fisher's non-parametric permutation test for ordered categorical variables and dichotomous variables for the differences. Numbers, percentages improved, not changed, worsened were analyzed with Mantel-Haenszel Exact Chi square over the course of 4 weeks in a 2x2 weeks treatment period inferiority will be established. | All data presented on the performance of the dressings reflect the FAS populations for the study comparison groups. |
| Chi-squared | 0.010 | Five-layer vs Hydropolymer arm; Weeks 1 & 3 | Superiority | In this superiority study the primary efficacy analysis included constructing a two sided 5% significance level, using Fisher's non-parametric permutation test for ordered categorical variables and dichotomous variables for the differences. Numbers, percentages improved, not changed, worsened were analyzed with Mantel-Haenszel Exact Chi square over the course of 4 weeks in a 2x2 weeks treatment period inferiority will be established. | All data presented on the performance of the dressings reflect the FAS populations for the study comparison groups. |
| Chi-squared | 0.25 | Five-layer vs Hydropolymer arm; Weeks 2 & 4 | Superiority | In this superiority study the primary efficacy analysis included constructing a two sided 5% significance level, using Fisher's non-parametric permutation test for ordered categorical variables and dichotomous variables for the differences. Numbers, percentages improved, not changed, worsened were analyzed with Mantel-Haenszel Exact Chi square over the course of 4 weeks in a 2x2 weeks treatment period inferiority will be established. | All data presented on the performance of the dressings reflect the FAS populations for the study comparison groups. |
| OG001 | Five-layer vs Hydrocellular | This arm was divided into 2 treatment groups:
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| OG001 | Five-layer vs Hydrocellular | This arm was divided into 2 treatment groups:
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This arm was divided into 2 treatment groups:
Bordered Five-Layer Foam Dressing: Bordered, five-layer, flexible foam dressing with soft silicone adhesive technology
Hydrocellular Multi-Layer Foam Dressing: Multi-layered, hydrocellular foam dressing with silicone adhesive
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