DermACELL in Subjects With Chronic Wounds of the Lower Extremities

LifeNet Health

Status: Completed

Conditions: Diabetic Foot Ulcer

Treatments: Other: Conventional Care Dressings; Other: GraftJacket; Other: DermACELL

Study type: Interventional

Funder types: Industry

Identifiers

NCT01970163

CR-13-001

Details and patient eligibility

About

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

Full description

This study is designed to demonstrate the effectiveness of DermACELL in the treatment of chronic wounds of the lower extremities. DermACELL will be compared to conventional care in both subjects with diabetic foot ulcers (DFU) and subjects with venous stasis ulcers (VSU). In addition, DermACELL will be compared to an active comparator, GraftJacket, in subjects with diabetic foot ulcers.

DermACELL and GraftJacket are both made from donated human skin (dermis). These products have been processed so that cells are removed and bacteria and viruses are destroyed. This processing provided a supporting structure, an acellular dermal matrix, into which cells can migrate and divide during the wound healing process.

Enrollment: 202 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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;

Exclusion criteria

• 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);

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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202 participants in 3 patient groups, including a placebo group

DermACELL

Experimental group

Description:

DermACELL acellular dermal matrix will be used to treat subjects diagnosed with an ulcer of the lower extremity (diabetic foot ulcer or venous stasis ulcer).

Treatment:

Other: DermACELL

Conventional care dressings

Placebo Comparator group

Description:

Currently accepted standard of care wound management including Conventional care dressings will be utilized in subjects with a diagnosis of either diabetic foot ulcer or venous stasis ulcer.

Treatment:

Other: Conventional Care Dressings

GraftJacket

Active Comparator group

Description:

GraftJacket acellular dermal matrix will be used in those subjects diagnosed with a diabetic foot ulcer.

Treatment:

Other: GraftJacket