Clinical trial NCT01970163: DermACELL in Subjects With Chronic Wounds of the Lower Extremities
Official title: A Multicenter, Randomized, Controlled, Open Label Trial of DermACELL in Subjects With Chronic Wounds of the Lower Extremities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcer
Keywords: Diabetic foot ulcer
Venous stasis ulcer
Wound of the lower extremity
Skin substitute
Acellular Dermal Matrix
Lead sponsor: LifeNet Health
Sponsor class: INDUSTRY
First posted: 2013-10-25
Enrollment: 202
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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);

Primary outcomes:
measure: Effect of DermACELL on the proportion of chronic wounds of the lower extremity that have healed.
timeFrame: 12 weeks
Secondary outcomes:
measure: Proportion of wounds closed at 12 weeks and weekly thereafter for up to 24 weeks
timeFrame: 24 weeks
Other outcomes:
measure: Incidence of treatment-emergent adverse events (AE), changes in vital signs, ankle-brachial index (ABI) and physical examination findings.
timeFrame: 24 weeks
Locations:
city: Montgomery
country: United States
facility: Institute for Advanced Wound Care
state: Alabama
city: Tucson
country: United States
facility: Southern Arizona VA Health Care System
state: Arizona
city: Carlsbad
country: United States
facility: ILD Research Center
state: California
city: Castro Valley
country: United States
facility: Center for Clinical Research
state: California
city: Fresno
country: United States
facility: Limb Preservation Platform
state: California
city: Fresno
country: United States
facility: Limb Preservation Platform
state: California
city: Norwalk
country: United States
facility: Fairfield County Foot Surgeons
state: Connecticut
city: Gulf Breeze
country: United States
facility: Andrews Research and Education Institute
state: Florida
city: North Chicago
country: United States
facility: Rosalind Franklin University, CLEAR
state: Illinois
city: Boston
country: United States
facility: Boston Medical College
state: Massachusetts
city: Dunmore
country: United States
facility: Wound Institute and Reseach Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System
state: Pennsylvania
Study officials:
affiliation: LifeNet Health, Scientific Affairs
name: Mark Moore, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Walters J, Cazzell S, Pham H, Vayser D, Reyzelman A. Healing Rates in a Multicenter Assessment of a Sterile, Room Temperature, Acellular Dermal Matrix Versus Conventional Care Wound Management and an Active Comparator in the Treatment of Full-Thickness Diabetic Foot Ulcers. Eplasty. 2016 Feb 4;16:e10. eCollection 2016.
citation: Cazzell S, Vayser D, Pham H, Walters J, Reyzelman A, Samsell B, Dorsch K, Moore M. A randomized clinical trial of a human acellular dermal matrix demonstrated superior healing rates for chronic diabetic foot ulcers over conventional care and an active acellular dermal matrix comparator. Wound Repair Regen. 2017 May;25(3):483-497. doi: 10.1111/wrr.12551. Epub 2017 Jun 12.