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



Status:Terminated
Conditions:Gastrointestinal, Podiatry, Diabetes
Therapuetic Areas:Endocrinology, Gastroenterology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - 85
Updated:4/17/2018
Start Date:May 2013
End Date:December 2015

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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

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.

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.

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 surgar 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
We found this trial at
9
sites
3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 687-7695
Georgetown University Medical Center Georgetown University Medical Center is committed to excellence in research, education...
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Castro Valley, California 94546
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Denver, Colorado 80220
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Fresno, California 93720
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Homestead, Florida 33035
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Miami Beach, Florida 33140
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1839 Central Avenue
Saint Petersburg, Florida 33713
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