Clinical Study to Compare 3 Multi-Layered Foam Dressings for the Management of Chronic Wounds

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective, Randomized, Controlled Study Using Cross-Over Design to Evaluate and Compare 3 Multi-Layered Foam Dressings for the Management of Chronic Wounds

Conditions
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Chronic Wound, Venous Leg Ulcer, Diabetic Foot Ulcer

Intervention / Treatment
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* Device: Bordered Five-Layer Foam Dressing
* Device: Hydropolymer Foam Dressing
* Device: Hydrocellular Multi-Layer Foam Dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female subjects 18-85 years of age with leg and foot ulcers (i.e. VLU, DFU). Signed informed consent. Subject and/or caregiver must be willing and able to tolerate multi-layered compression bandages when applicable and offloading footwear. Study subject must be available and able to visit the clinic weekly for the full 4-week period. Exclusion Criteria: Pressure ulcers should not be included. Pressure injury as defined by the National Pressure Ulcer Advisory Panel (NPUAP). Presence of local wound infection as determined by study doctor based on clinical signs and symptoms. Subject has any evidence of peripheral arterial disease (PAD). Subject diagnosed with malignancy other than cutaneous basal cell carcinoma. Subject has received growth factor therapy (e.g. autologous platelet-rich plasma gel, becaplermin, bilayered cell therapy, dermal substitute, extracellular matrix e.g. amnion, amniotic tissue) within 2 weeks of screening date. Pregnancy or lactation at time of study participation. Subject is currently receiving or has received radiation or chemotherapy within 3 months of randomization. Subject is currently enrolled or participated in another investigational device, drug or biological trial within 30 days of baseline of this study. Present history of alcohol or drug abuse. Known allergy/hypersensitivity to any of the components of the dressing. Subject not suitable for the investigation according to the investigator's judgment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Five-layer vs Hydropolymer<br>Bordered Five-layer Foam Dressing for 2 weeks, followed by Hydropolymer Foam Dressing for 2 weeks. | Device: Bordered Five-Layer Foam Dressing<br>* Bordered, five-layer, flexible foam dressing with soft silicone adhesive technology<br>* Other names: Five-layer;Device: Hydropolymer Foam Dressing<br>* Hydropolymer, adhesive foam island dressing<br>* Other names: Hydropolymer;|
| Active Comparator: Hydropolymer vs Five-layer<br>Hydropolymer Foam Dressing for 2 weeks, followed by Bordered Five-layer Foam Dressing for 2 weeks | Device: Bordered Five-Layer Foam Dressing<br>* Bordered, five-layer, flexible foam dressing with soft silicone adhesive technology<br>* Other names: Five-layer;Device: Hydropolymer Foam Dressing<br>* Hydropolymer, adhesive foam island dressing<br>* Other names: Hydropolymer;|
| Active Comparator: Five-layer vs Hydrocellular<br>Bordered Five-layer Foam Dressing for 2 weeks, followed by Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks. | Device: Bordered Five-Layer Foam Dressing<br>* Bordered, five-layer, flexible foam dressing with soft silicone adhesive technology<br>* Other names: Five-layer;Device: Hydrocellular Multi-Layer Foam Dressing<br>* Multi-layered, hydrocellular foam dressing with silicone adhesive<br>* Other names: Hydrocellular;|
| Active Comparator: Hydrocellular vs Five-layer<br>Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks, followed by Bordered Five-layer Foam Dressing for 2 weeks | Device: Bordered Five-Layer Foam Dressing<br>* Bordered, five-layer, flexible foam dressing with soft silicone adhesive technology<br>* Other names: Five-layer;Device: Hydrocellular Multi-Layer Foam Dressing<br>* Multi-layered, hydrocellular foam dressing with silicone adhesive<br>* Other names: Hydrocellular;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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: Inappropriate dressing type Inappropriate dressing change freq. (i.e. more frequent changes required) Change in wound condition (e.g. increase in exudate amt) Dislodgement of dressing: Suboptimal dressing application (e.g. selection of inappropriate dressing size, failure to clean periwound skin before applying dressing, insufficient fixation) Exposure of dressing to mechanical forces (e.g. off-loading devices, patient mobility) Patient interference w/ dressing Dressing design deficiency: Insufficient fluid handling capacity (absorption, retention and/or moisture vapor transmission) Insufficient adhesion Insufficient conformability (i.e. ability to conform to body contours & challenging anatomical wound locations) | 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: Inappropriate dressing type Inappropriate dressing change freq. (i.e. more frequent changes required) Change in wound condition (e.g. increase in exudate amt) Dislodgement of dressing: Suboptimal dressing application (e.g. selection of inappropriate dressing size, failure to clean periwound skin before applying dressing, insufficient fixation) Exposure of dressing to mechanical forces (e.g. off-loading devices, patient mobility) Patient interference w/ dressing Dressing design deficiency: Insufficient fluid handling capacity (absorption, retention and/or moisture vapor transmission) Insufficient adhesion Insufficient conformability (i.e. ability to conform to body contours & challenging anatomical wound locations) | Weeks 1 and 3 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic wound, Venous Leg Ulcer, Diabetic Foot Ulcer, Wound dressing