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

Completed · Not applicable

Conditions studied: Venous Leg Ulcer

In brief

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).

Key facts

Study ID: NCT03589586
Run by: LifeNet Health
People needed: 100
Starts: 2018-06-25
Expected to finish: 2021-03-15
Last updated by the study team: 2021-03-18

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 0.75.
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
Have provided written authorization for use and disclosure of protected health information
Have a life expectancy of greater than 6 months

You may not qualify if…

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
Have a known or suspected disease of the immune system
Have an active or untreated malignancy or active, uncontrolled connective tissue disease
Had a treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids less than 30 days before the baseline visit
Have presence of necrosis, purulence, or sinus tracts that cannot be removed by debridement
Has undergone a revascularization procedure aimed at increasing blood flow in the treatment target limb less than 4 weeks before the baseline visit
Have serum aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase levels greater than three times the normal upper limit within 30 days prior to screening
Have active Charcot disease
Have undergone treatment with a living skin equivalent within the last 4 weeks before the screening visit
Have ongoing evidence of peripheral vascular disease, including greater than one nonpalpable pulse on either foot
Have the presence of any condition that in the opinion of the investigator places the subject at undue risk or potentially jeopardizes the quality of the data to be generated

Where it is running

Arizona Regional Medical Research — Tucson, Arizona, United States
Southern Arizona VA Health Care System Department of Podiatry — Tucson, Arizona, United States
Limb Preservation Platform — Fresno, California, United States
LA Foot and Ankle Clinic — Los Angeles, California, United States
South Florida Podiatry — Deerfield Beach, Florida, United States
Doctors Research Network — South Miami, Florida, United States
Purvis Moyer Foot and Ankle Center — Rocky Mount, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.