DermACELL in Subjects With Chronic Wounds of the Lower Extremities

Completed · Not applicable

Conditions studied: Diabetic Foot Ulcer

In brief

The study will compare treatment with DermACELL to conventional care in diabetic foot ulcers (DFU) and venous stasis ulcers (VSU).

Key facts

Study ID

NCT01970163

Run by

LifeNet Health

People needed

202

Starts

2013-10-01

Expected to finish

2016-04-01

Last updated by the study team

2018-03-14

Who can join

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

You may qualify if…

• Male and female between the ages of 21 and 80 that are able to provide informed consent, are available for weekly clinic visits and are willing to comply with off-loading requirements of treatment;
• If diabetic, have been on a stable dose of medication to treat diabetes for less than 30 days;
• Have a DFU that has been present for at least 30 days or have a VSU that has been present for at least 60 days;

You may not qualify if…

• Have a DFU or VSU that is infected;
• Are pregnant or lactating;
• Have an allergy or are sensitive to one of the following antibiotics: lincomycin, gentamicin, polymyxin B, or vancomycin;
• Have a sensitivity to polysorbate 20, N-lauroyl sarcosinate, benzonase or glycerol;
• Have had a HbA1c level greater than 12% within the past 90 days;
• Have liver function tests or kidney function tests that are very elevated;
• Have a known or suspected disease of the immune system;
• Have had surgery in the past 30 days to increase blood flow into your leg or foot;
• Have cancer or a connective tissue disease (i.e. lupus, rheumatoid arthritis);
• Have undergone wound healing treatment with a living skin equivalent (i.e., Dermagraft®, Apligraf®, TheraSkin®, Oasis®, GraftJacket®, Integra®, Alloderm®) or topical growth factors in the last 4 weeks;
• Have active Charcot disease, a weakening of the bones in the foot that can occur in people who have significant nerve damage (neuropathy);

Where it is running

• Institute for Advanced Wound Care — Montgomery, Alabama, United States
• Southern Arizona VA Health Care System — Tucson, Arizona, United States
• ILD Research Center — Carlsbad, California, United States
• Center for Clinical Research — Castro Valley, California, United States
• Limb Preservation Platform — Fresno, California, United States
• Limb Preservation Platform — Fresno, California, United States
• Fairfield County Foot Surgeons — Norwalk, Connecticut, United States
• Andrews Research and Education Institute — Gulf Breeze, Florida, United States
• Rosalind Franklin University, CLEAR — North Chicago, Illinois, United States
• Boston Medical College — Boston, Massachusetts, United States
• Wound Institute and Reseach Center — Dunmore, Pennsylvania, United States
• VA Pittsburgh Healthcare System — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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