A Comparative Efficacy Study: Treatment for Non-healing Diabetic Foot Ulcers

Not Applicable

Terminated

Brief Summary: The primary objective of this study is to assess the effectiveness of MatriStem devices compared to cellular dermal replacement tissue, for the treatment of non-healing diabetic foot ulcers.

Detailed Description: Due to their characteristically poor healing capacity, diabetic foot ulcers (DFUs) are challenging for clinicians to treat. This prospective, multi-center clinical study will examine outcomes following treatment of DFUs, with one of two FDA cleared tissue-engineered devices, MatriStem® or cellular dermal replacement tissue, on DFUs that have demonstrated an inadequate response to initial standard of care therapy. The incidence of ulcer closure, rate of wound closure, and quality of life will be evaluated over a eight week period.

Recruitment & Eligibility

Inclusion Criteria

Subject has a current diagnosis of type I or type II diabetes
Subject's ulcer is on the forefoot or heel
Subject has chronic ulcer - has been present for minimum of 4 weeks
Subject's ulcer extends through the dermis and into the subcutaneous tissue
Subject's HgbA1c <12%
Subject has adequate circulation to the study foot as evidenced by a Doppler measured ABI greater than or equal to 0.7after 10 minutes rest

Major

Exclusion Criteria

Subject has a known sensitivity to bovine- or porcine-derived products.
Subject's ulcer is due to a non-diabetic etiology
Subject's ulcer is over a Charcot deformity of the mid-foot
Subject's random blood sugar readings are >450 mg/dL
Subject is on dialysis
Subject has a non-study ulcer on the study limb located within 7.0 cm of the study ulcer

Primary Outcome Measures

Name	Time	Method
Number of Participants With Complete Wound Closure	8 Weeks	Number of participants with incidence of complete wound closure

Secondary Outcome Measures

Name	Time	Method

Locations (9): Carl t. Hayden Phoenix VA Medical Center
🇺🇸
Phoenix, Arizona, United States
Associated Foot & Ankle Specialists, PC
🇺🇸
Phoenix, Arizona, United States
Center for Clinical Research Inc.
🇺🇸
Castro Valley, California, United States
Valley Vascular Surgery Associates
🇺🇸
Fresno, California, United States
Denver VA Medical Center
🇺🇸
Denver, Colorado, United States
Georgetown University Medical Center
🇺🇸
Washington, District of Columbia, United States
Advanced Research Institute of Miami
🇺🇸
Homestead, Florida, United States
NewPhase Clinical Trials, Corp.
🇺🇸
Miami Beach, Florida, United States
Professional Health Care of Pinellas
🇺🇸
Saint Petersburg, Florida, United States
Carl t. Hayden Phoenix VA Medical Center
🇺🇸Phoenix, Arizona, United States