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

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Evaluation of Tissue Engineering Approaches for Treatment of Neuropathic Diabetic Foot Ulcers Resistant to Standard of Care: A Prospective, Randomized Controlled Trial

Conditions
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Foot Ulcer, Diabetic

Intervention / Treatment
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* Device: MatriStem
* Device: Cellular Dermal Replacement Tissue


Participation Criteria
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Eligibility Criteria
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Major 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>MatriStem MicroMatrix and MatriStem Wound Matrix | Device: MatriStem<br>* MatriStem MicroMatrix and MatriStem Wound Matrix<br>|
| Active Comparator: Comparator<br>Cellular Dermal Replacement Tissue | Device: Cellular Dermal Replacement Tissue<br>* Cellular Dermal Replacement Tissue<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Complete Wound Closure | Number of participants with incidence of complete wound closure | 8 Weeks |