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The aim of this study is to compare the clinical efficacy of two types of NPWT systems; the traditional negative pressure wound therapy (tNPWT) system and the single-use negative pressure wound therapy (PICO) system.
The two types of NPWT systems include the tNPWT system that has successfully completed a coding verification request with CMS and has the following capabilities (e.g., range of negative pressure, connective tubing, canister, foam or gauze filler, and approved for home use), and a portable, canister-less, battery operated, disposable PICO system to see if there are any observed differences with regard to the clinical efficacy of the two devices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PICO System | Experimental | Negative Pressure Wound Therapy (NPWT) at 80mmHg (nominal) +/- 20 mmHg to the wound surface |
|
| tNPWT System | Active Comparator | Traditional NPWT (tNPWT) from -25 mmHg and up to -200 mmHg; intensity settings of either low, medium and high; delivery modes of continuous or intermittent. The pressure, intensity and delivery settings will be left to the Investigator's discretion at each study treatment visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PICO System | Device | Negative Pressure Wound Therapy (NPWT) at 80mmHg (nominal) +/- 20 mmHg to the wound surface |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Ulcer Area From Baseline to the End of the Treatment Period | Ulcer area was photographed in order to determine the measurements of the post-debridement ulcer area (cm^2 and total percentage [%]) using the ARANZ Silhouette wound imaging and measurement device. | Baseline through 12 weeks |
| Percentage Change in Ulcer Area From Baseline to the End of the Treatment Period | Ulcer area was photographed in order to determine the measurements of the postdebridement ulcer area (cm^2 and total percentage [%]) using the ARANZ Silhouette wound imaging and measurement device. | Baseline through 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Target Ulcer Depth Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period | Ulcer area was analyzed for depth measurement in millimeters (mm), volume measurement in cubic centimeters (cm^3), and percentage change (%) including terms for treatment, baseline depth, baseline volume, wound type, pooled sites, and wound duration using the ARANZ Silhouette wound imaging and measurement device. |
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INCLUSION CRITERIA:
EXCLUSION CRITERIA
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| Name | Affiliation | Role |
|---|---|---|
| Andy Weymann, MD, MBA | Smith & Nephew, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ILD Consulting, Inc. | Carlsbad | California | 92009 | United States | ||
| Valley Foot & Ankle Specialty Providers |
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| ID | Title | Description |
|---|---|---|
| FG000 | PICO System | Subjects randomized to receive the PICO system applied to the target ulcer area over the 12-week treatment period from Baseline. |
| FG001 | tNPWT System | Subjects randomized to receive the tNPWT system applied to the target ulcer area over the 12-week treatment period from Baseline. |
| 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 | Yes | No | No | Study Protocol | Aug 22, 2016 | Dec 10, 2018 |
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| tNPWT System | Device | NPWT from -25 mmHg and up to -200 mmHg; intensity settings of either low, medium and high; delivery modes of continuous or intermittent. The pressure, intensity and delivery settings will be left to the Investigator's discretion at each study treatment visit. |
|
| Baseline through 12 weeks |
| Change in Target Ulcer Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period | Ulcer area was analyzed for depth measurement in millimeters (mm), volume measurement in cubic centimeters (cm^3), and percentage change (%) including terms for treatment, baseline depth, baseline volume, wound type, pooled sites, and wound duration using the ARANZ Silhouette wound imaging and measurement device. | Baseline through 12 weeks |
| Percentage Change in Target Ulcer Depth and Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period | Ulcer area was analyzed for depth measurement in millimeters (mm), volume measurement in cubic centimeters (cm^3), and percentage change (%) including terms for treatment, baseline depth, baseline volume, wound type, pooled sites, and wound duration using the ARANZ Silhouette wound imaging and measurement device. | Baseline through 12 weeks |
| Fresno |
| California |
| 93720 |
| United States |
| The Sun Healthcare & Surgery Group | Martinez | California | 94553 | United States |
| Center for Clincial Research | San Francisco | California | 94115 | United States |
| Olive View - UCLA Medical Center | Sylmar | California | 91342 | United States |
| University of Miami | Miami | Florida | 33125 | United States |
| NW University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
| Rosalind Franklin University of Med & Science | North Chicago | Illinois | 60064 | United States |
| Ochsner Health System | New Orleans | Louisiana | 70121 | United States |
| Rubin Institute for Advanced Orthopedics | Baltimore | Maryland | 21215 | United States |
| Advanced Foot & Ankle | Las Vegas | Nevada | 89119 | United States |
| Center for Advanced Wound Care | Wyomissing | Pennsylvania | 19610 | United States |
| Acclaim Bone & Joint | Fort Worth | Texas | 76104 | United States |
| Futuro Clinical Trials, LLC | McAllen | Texas | 78501 | United States |
| Carilion Clinic | Roanoke | Virginia | 24013 | United States |
| The Mayer Institute | Hamilton | Ontario | L8R 2R3 | Canada |
| Centre podiatrique et soins des plaies | Boucherville | Quebec | J4B 5E4 | Canada |
| COMPLETED |
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| NOT COMPLETED |
|
|
The Safety analysis included all enrolled subjects (N=164), however, 3 subjects did not complete a follow-up visit and thus were excluded from all Baseline and Outcome Measure analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | PICO System | Subjects randomized to receive the PICO system applied to the target ulcer area over the 12-week treatment period from Baseline. |
| BG001 | tNPWT System | Subjects randomized to receive the tNPWT system applied to the target ulcer area over the 12-week treatment period from Baseline. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| BMI (kg/m^2) | Mean | Standard Deviation | kg/m^2 |
|
| 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 Ulcer Area From Baseline to the End of the Treatment Period | Ulcer area was photographed in order to determine the measurements of the post-debridement ulcer area (cm^2 and total percentage [%]) using the ARANZ Silhouette wound imaging and measurement device. | The Per-Protocol (PP) population was used to analyze outcome measure data and included all subjects who were randomized, met inclusion/exclusion criteria, had not discontinued treatment within the first 9 weeks (-1 day), and had no significant protocol deviations. | Posted | Mean | Standard Deviation | cm^2 | Baseline through 12 weeks |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage Change in Ulcer Area From Baseline to the End of the Treatment Period | Ulcer area was photographed in order to determine the measurements of the postdebridement ulcer area (cm^2 and total percentage [%]) using the ARANZ Silhouette wound imaging and measurement device. | The Per-Protocol (PP) population was used to analyze outcome measure data and included all subjects who were randomized, met inclusion/exclusion criteria, had not discontinued treatment within the first 9 weeks (-1 day), and had no significant protocol deviations. | Posted | Mean | Standard Deviation | Percentage of change in wound area | Baseline through 12 weeks |
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| Secondary | Change in Target Ulcer Depth Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period | Ulcer area was analyzed for depth measurement in millimeters (mm), volume measurement in cubic centimeters (cm^3), and percentage change (%) including terms for treatment, baseline depth, baseline volume, wound type, pooled sites, and wound duration using the ARANZ Silhouette wound imaging and measurement device. | Change in wound depth over 12-week treatment period by treatment group (PP population - all wounds) | Posted | Mean | Standard Deviation | mm | Baseline through 12 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Target Ulcer Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period | Ulcer area was analyzed for depth measurement in millimeters (mm), volume measurement in cubic centimeters (cm^3), and percentage change (%) including terms for treatment, baseline depth, baseline volume, wound type, pooled sites, and wound duration using the ARANZ Silhouette wound imaging and measurement device. | Change in wound volume over 12-week treatment period by treatment group (PP population - all wounds) | Posted | Mean | Standard Deviation | cm^3 | Baseline through 12 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage Change in Target Ulcer Depth and Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period | Ulcer area was analyzed for depth measurement in millimeters (mm), volume measurement in cubic centimeters (cm^3), and percentage change (%) including terms for treatment, baseline depth, baseline volume, wound type, pooled sites, and wound duration using the ARANZ Silhouette wound imaging and measurement device. | Percentage change in wound depth and volume over 12-week treatment period by treatment group (PP population - all wounds) | Posted | Mean | Standard Deviation | percent change | Baseline through 12 weeks |
|
|
Adverse events were collected from Baseline through 12 weeks of treatment or study withdrawal, whichever came first.
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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 | PICO System | Subjects randomized to receive the PICO system applied to the target ulcer area over the 12-week treatment period from Baseline. | 2 | 80 | 6 | 80 | 65 | 80 |
| EG001 | tNPWT System | Subjects randomized to receive the tNPWT system applied to the target ulcer area over the 12-week treatment period from Baseline. | 0 | 84 | 8 | 84 | 57 | 84 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abscess | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Aneurysm | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cellulitis | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Congestive heart failure | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Diastolic heart failure | Cardiac disorders | MedDRA (19.0) | Systematic Assessment | Acute-on-chronic |
|
| Fluid collection | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | Thigh |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Psychiatric evaluation | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Respiratory insufficiency | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Sepsis | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Suicide | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Ulcer increased in size | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Wound infection | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Target ulcer increase in size > 75% from Baseline | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Excessive maceration | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Excessive intermittent maceration right plantar forefoot target ulcer | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | Intermittent events caused intermittent stoppages in therapy. The AE was considered mild. |
|
| Deep venous thrombosis right lower leg | Vascular disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered moderate. |
|
| Right lateral midfoot blister | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered moderate. |
|
| Increased peri-wound maceration | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Target venous leg ulcer maceration | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Subject could not tolerated NPWT, it was uncomfortable for the subject | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Peri-ulcer tissue very macerated | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered moderate. |
|
| Left foot target ulcer cellulitis | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Methicillin-resistant Staphylococcus aureus infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Target ulcer infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment | The AE was considered moderate. |
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| Cellulitis to left 3rd interspace | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered moderate. |
|
| Subjective complaint of ulcer pain | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
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| Abrasion at 10 o'clock from left distal dorsal TMA | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
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| Cellulitis of left plantar medial midfoot | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered moderate. |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Urinary tract infection | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Acute bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Right ear infection | Ear and labyrinth disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Right thigh fluid collection with right groin incision site related drainage | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered moderate. |
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| Venous stasis ulcer pain | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
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| High blood pressure | Vascular disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered moderate. |
|
| Allergic contact dermatitis of the right leg | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
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| Left ankle swelling | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered moderate. |
|
| Left sole wound infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment | The AE was considered moderate. |
|
| Allergic contact dermatitis of skin surrounding right foot ulcer | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered moderate. |
|
| Stasis dermatitis, xerosis | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Stasis dermatitis | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered moderate. |
|
| Contact dermatitis | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered moderate. |
|
| Erythema intertrigo | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Peri-wound maceration on left foot | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Peri-wound margin increase in maceration | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered moderate. |
|
| Wound increased in size | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered moderate. |
|
| Regression in wound - size of wound increased by more than 75% from last visit | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered moderate. |
|
| Peri-wound maceration on right foot | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Wound macerated | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Pressure-related pain from negative pressure | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered moderate. |
|
| Peri-wound maceration | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Pruritus RLE | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
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| Blistered skin right lower extremity | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Probable osteomyelitis right foot at target ulcer | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered moderate. |
|
| Excoriations, maceration peri-wound | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Macerated skin left leg | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Redness, swelling, and discomfort right leg | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Progressive disease - worsening of target ulcer causing subject to be discontinued from study | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered moderate. |
|
| Worsening of coronary artery disease | Cardiac disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered moderate. |
|
| Femur fracture | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered moderate. |
|
| Fall | General disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Infected pimple on face | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| DFU (target ulcer) progressive disease | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered moderate. |
|
| Target wound pain | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered moderate. |
|
| New non-target ulcer near target ulcer on right shin | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| New non-target ulcer near target ulcer 0.5 cm in size | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
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| Target wound pain decreased | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
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| Debridement pain on target ulcer | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Right upper quadrant/back pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered moderate. |
|
| Non-target ulcer on lateral side of left leg | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Multiple skin tears around target ulcer site | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Water blister on medial side of left leg | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Skin tear adjacent to target ulcer on left leg | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Three skin tears 2 cm away from target wound | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Non-target wound on right lateral ankle | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Maceration | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Two skin tears away from target wound (anterior) | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Two skin tears posterior to left leg | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Multple skin tears from target wound anterior left leg | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Non-target wound on left leg | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Small irritations around where dressing puts pressure on left leg | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Left medial ankle venous leg ulcer bacterial colonization of wound bed | Infections and infestations | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Peri-wound skin irritated | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Right target ulcer larger | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Venous ulcer right leg malleolus increase in wound size | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Cellulitis of right foot | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered moderate. |
|
| Wet gangrene 4th digit left foot | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered moderate. |
|
| Peri-wound inflammation target leg left VLU | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Large amount of drainage from target ulcer, left leg calf | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Foot edema | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Foot blistering on dorsal and medial surface | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Suspected non-target ulcer infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment | The AE was considered moderate. |
|
| Formed a blister on anterior shin from tNPWT bridge | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Venous leg ulcer on left lateral leg | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Ulcer on dorsal portion of right foot | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Worsening of left ankle pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Abdominal pain, epigastric | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Episode of recurrent major depressive disorder | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered moderate. |
|
| Suicidal ideation | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Constipation | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Osteomyelitis of ankle/foot | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered moderate. |
|
| Bilateral lower extremity edema | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Dyspnea on exertion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Acute urinary retention | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Complication of Foley catheter | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Acute abdominal pain | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Edema, unspecified | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Suspected cellulitis | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered moderate. |
|
| Intermittent burning/stabbing pain x1 week | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Left side of nose epidermal inclusion cyst | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Left lower abdomen epidermal cyst inflamed | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Left lower leg swelling | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered moderate. |
|
| Prolonged pain at target ulcer | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Bone exposure at target ulcer | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered moderate. |
|
| Wound undermining < 2 cm | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Bulla right foot lateral side | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Progressive disease - wound size met the definition of progressive disease | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered moderate. |
|
| Burning pain in foot of target ulcer | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Epigastric pain | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Target ulcer pain | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered moderate. |
|
| Scrotal edema | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered moderate. |
|
| Hypokalemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Contact dermatitis on left foot | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Acute on chronic congestive heart failure | Cardiac disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered moderate. |
|
| Paroxysmal atrial fibrillation | Cardiac disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered moderate. |
|
| Wound infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Bone necrosis | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Left ankle and lower leg pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Body rash | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Additional ulcer left ankle | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Right mid thigh lacerations | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Increased maceration | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Fracture of vertebral disk | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered moderate. |
|
| Reopening of ulcers on target limb | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered moderate. |
|
| Worsening of recurring non-target ulcers on target limb | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered moderate. |
|
| Worsening of target ulcer | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Lower respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Redness, skin breakdown to target limb | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
| Swelling of the right foot | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | The AE was considered mild. |
|
There were no known limitations or caveats reported during this study.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Natasha Schappell, CCRP | Smith & Nephew, Inc. | 817-302-3949 | natasha.schappell@smith-nephew.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 5, 2015 | Dec 10, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D014647 | Varicose Ulcer |
| D014456 | Ulcer |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D014648 | Varicose Veins |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United States |
|
| Change in wound area |
|
|
|
|
|