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

Diabetic Foot Ulcer Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03662997
Study type Interventional
Source Molnlycke Health Care AB
Contact
Status Completed
Phase N/A
Start date March 19, 2019
Completion date November 15, 2019
View Details
See also
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