An Evaluation of Tissue Engineering Approaches for Treatment of Neuropathic Diabetic Foot Ulcers Resistant to Standard of Care: A Prospective, Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Foot Ulcer, Diabetic
- Sponsor
- Integra LifeSciences Corporation
- Enrollment
- 56
- Locations
- 9
- Primary Endpoint
- Number of Participants With Complete Wound Closure
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Number of Participants With Complete Wound Closure
Time Frame: 8 Weeks
Number of participants with incidence of complete wound closure