NCT03589586

Clinical Effectiveness of DermACELL AWM in Subjects With Chronic Venous Leg Ulcers

An Open-Label Trial to Assess the Clinical Effectiveness of DermACELL AWM in Subjects With Chronic Venous Leg Ulcers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: LifeNet Health · Industry
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, randomized, controlled, open-label trial designed to evaluate the safety and efficacy of DermACELL in subjects with a single target chronic venous leg ulcer (VLU).

Detailed description

This study is a multicenter, randomized, controlled, open-label trial designed to evaluate the safety and efficacy of DermACELL in subjects with a single target chronic venous leg ulcer (VLU). After eligibility is determined at a screening visit, VLU subjects will be entered into a 2 week run-in period of conventional wound care with moist wound therapy and multilayer compression bandage. At baseline, those continuing to meet eligibility criteria will be randomized to either DermACELL or conventional care wound management at a ratio of 1:1. The appropriate size of DermACELL will be applied to the wound of subjects in the DermACELL arm. The ADM will be attached with sutures, sterile adhesive strips, or bioadhesive, and covered with a dressing. For subjects in the conventional care wound management arm, the debrided wound will undergo a moist-wound therapy consisting of alginates, foams, or hydrogels, and will be covered with a gauze that is appropriate for the type of wound (moist or dry). Subsequent study visits will occur every week until 100% re-epithelialization or up to 16 weeks after treatment (whichever comes first).

Conditions

• Venous Leg Ulcer

Interventions

Type	Name	Description
OTHER	DermACELL AWM	DermACELL AWM is a sterile, ready to use acellular dermal matrix

Timeline

• Start date: 2018-06-25
• Primary completion: 2021-01-15
• Completion: 2021-03-15
• First posted: 2018-07-18
• Last updated: 2021-03-18

Locations

7 sites across 1 country: United States