Clinical Study to Compare 3 Multi-Layered Foam Dressings for the Management of Chronic Wounds
Condition: Chronic Wound; Venous Leg Ulcer; Diabetic Foot Ulcer
MeSH terms: Diabetic Foot; Varicose Ulcer; Foot Ulcer; Leg Ulcer; Ulcer; Wounds and Injuries
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): Bordered Five-Layer Foam Dressing; Hydropolymer Foam Dressing; Hydrocellular Multi-Layer Foam Dressing
Intervention type(s): Device; Device; Device
Intervention description(s): Bordered, five-layer, flexible foam dressing with soft silicone adhesive technology; Hydropolymer, adhesive foam island dressing; Multi-layered, hydrocellular foam dressing with silicone adhesive
Other intervention name(s): Five-layer; Hydropolymer; Hydrocellular
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention 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)
Primary purpose: Treatment
Keywords: Chronic wound; Venous Leg Ulcer; Diabetic Foot Ulcer; Wound dressing