An Open-Label Trial to Assess the Clinical Effectiveness of DermACELL AWM in Subjects With Chronic Venous Leg Ulcers
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Venous Leg Ulcer
- Sponsor
- LifeNet Health
- Enrollment
- 100
- Locations
- 7
- Primary Endpoint
- Healing Rate
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief 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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Have been on a stable anti-diabetic treatment for at least 30 days before the baseline visit if the subject has a diagnosis of Type 1 or Type 2 diabetes as defined by the American Diabetes Association
- •Have a full-thickness venous leg ulcer that does not penetrate into the muscle, tendon or bone.
- •Have a single target ulcer
- •Have a wound with an area greater than or equal to 1 cm2 and less than 25 cm2 and a depth less than or equal to 9 mm
- •Have a venous stasis ulcer that has been present for at least 30 days.
- •Have a Clinical severity, Etiology or cause, Anatomy and Pathophysiology ulcer classification (CEAP) Grade C6: an open venous ulcer
- •Have an absence of infection based on Infectious Disease Society of America criteria
- •Have adequate circulation to the affected lower extremity, defined as an Ankle-brachial index (ABI) greater than 0.
- •Have the ability to comply with off-loading (if required for specific wound), compression and dressing change requirements
- •Have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an institutional review board (IRB), and agree to abide by the study restrictions and return to the site for the required assessments
Exclusion Criteria
- •Be pregnant or lactating
- •Have a venous leg ulcer on the dorsum of the foot or more than 50% of the ulcer is below the malleolus
- •Have circulating hemoglobin A1c exceeding 12% within 90 days of the screening visit
- •Have serum creatinine concentrations of 3.0 mg/dL or greater within 30 days prior to screening
- •Have a sensitivity to either of the following antibiotics: lincomycin, gentamicin, polymyxin B, or vancomycin
- •Have a sensitivity to polysorbate 20, N-lauroyl sarcosinate, benzonase or glycerol
- •Have the wound treated with biomedical or topical growth factors within the previous 30 days before the screening visit
- •Need for any additional concomitant dressing material other than the ones approved for this study
- •Have clinical signs of an infection at the study ulcer site
- •Have the inability to tolerate compression bandage
Outcomes
Primary Outcomes
Healing Rate
Time Frame: 16 Weeks
effect of DermACELL on the proportion of chronic venous leg ulcers that have achieved 100% re-epithelialization without drainage or dressing requirements
Secondary Outcomes
- Time to wound closure(16 Weeks)