A Comparative Efficacy Study: Treatment for Non-healing Diabetic Foot Ulcers
- Conditions
- Foot Ulcer, Diabetic
- Registration Number
- NCT01858545
- Lead Sponsor
- Integra LifeSciences Corporation
- 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
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 56
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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
Trial Locations
- 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