DermACELL in Subjects With Chronic Wounds of the Lower Extremities

Not Applicable

Completed

• Conditions: Diabetic Foot Ulcer
• Interventions: Other: GraftJacket; Other: DermACELL; Other: Conventional Care Dressings

• Registration Number: NCT01970163
• Lead Sponsor: LifeNet Health

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-22
• Study First Submitted QC: 2013-10-22
• Study First Posted: 2013-10-25
• Primary Completion: 2016-01
• Study Completion: 2016-04
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-12
• Last Update Posted: 2018-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

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);

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GraftJacket	GraftJacket	GraftJacket acellular dermal matrix will be used in those subjects diagnosed with a diabetic foot ulcer.
DermACELL	DermACELL	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).
Conventional care dressings	Conventional Care Dressings	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.

Primary Outcome Measures

Name	Time	Method
Effect of DermACELL on the proportion of chronic wounds of the lower extremity that have healed.	12 weeks	The primary outcome is the comparison of the proportion of chronic wounds treated with DermACELL and treated with conventional care that have achieved 100% re-epithelialization without dressing or drainage requirements at 12 weeks. Wound closure is defined as first observation of 100% re-epithelialization without drainage or dressing requirements and complete wound closure is defined as 100% re-epithelialization without dressing or drainage requirements confirmed at two consecutive study visits 2 weeks apart.

Secondary Outcome Measures

Name	Time	Method
Proportion of wounds closed at 12 weeks and weekly thereafter for up to 24 weeks	24 weeks	The proportion of subjects with closed wounds at 12 weeks and weekly thereafter will be compared in subjects treated with DermACELL, GraftJacket (Diabetic foot ulcer subjects only) and conventional care wound management. A comparison of the proportion of subjects who received a second application of acellular dermal matrix will be made between the DermACELL and GraftJacket arms in those subjects with diabetic foot ulcers.

Trial Locations

Locations (11)

Center for Clinical Research; 🇺🇸 Castro Valley, California, United States

ILD Research Center; 🇺🇸 Carlsbad, California, United States

Institute for Advanced Wound Care; 🇺🇸 Montgomery, Alabama, United States

Andrews Research and Education Institute; 🇺🇸 Gulf Breeze, Florida, United States

Wound Institute and Reseach Center; 🇺🇸 Dunmore, Pennsylvania, United States

Rosalind Franklin University, CLEAR; 🇺🇸 North Chicago, Illinois, United States

Limb Preservation Platform; 🇺🇸 Fresno, California, United States

Fairfield County Foot Surgeons; 🇺🇸 Norwalk, Connecticut, United States

Boston Medical College; 🇺🇸 Boston, Massachusetts, United States

VA Pittsburgh Healthcare System; 🇺🇸 Pittsburgh, Pennsylvania, United States

Southern Arizona VA Health Care System; 🇺🇸 Tucson, Arizona, United States