A Safety and Efficacy Study of INTEGRA® Dermal Regeneration Template for the Treatment of Diabetic Foot Ulcers



Status:Completed
Conditions:Gastrointestinal, Podiatry, Diabetes
Therapuetic Areas:Endocrinology, Gastroenterology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:April 2010
End Date:July 2014

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A Multi-Center, Randomized, Controlled Clinical Trial to Evaluate The Safety and Effectiveness of Integra® Dermal Regeneration Template for the Treatment of Neuropathic Diabetic Foot Ulcers

The objective of this study is to evaluate the safety and effectiveness of the INTEGRA®
Dermal Regeneration Template for the treatment of diabetic foot ulcers located distal to the
malleolus in subjects with diabetes mellitus, neuropathy, and without significantly
compromised arterial circulation.


Inclusion Criteria:

- Type I or Type II diabetes mellitus

- Glycosylated hemoglobin, HbA1c, ≤ 12%

- Diabetic foot ulcer located below the ankle and/or on the bottom of the foot which
has been present for 30 days and is sufficient size to qualify for the study

- Good vascular perfusion of the affected limb

Exclusion Criteria:

- Gangrene, infection, or osteomyelitis

- Sensitivity to bovine collagen and/or chondroitin.

- Ulcers resulting from other health conditions besides diabetes

- Conditions or laboratory values which are not within the specified ranges
We found this trial at
33
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4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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Amherst, New York 14226
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Atlanta, Georgia 30308
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Bakersfield, California 93309
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Bay Pines, Florida 33744
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Boston, Massachusetts 02118
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Cambridge, Massachusetts 02139
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Castro Valley, California 94546
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Dallas, Texas 75231
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Dallas, Texas 75390
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East Setauket, New York 11733
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El Centro, California 92243
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Fair Oaks, California 95628
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Fresno, California 94115
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Idaho Falls, Idaho 83404
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Indianapolis, Indiana 46280
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Las Vegas, Nevada 89119
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Metarie, Louisiana 70006
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Miami, Florida 33175
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Missoula, Montana
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Mobile, Alabama 36608
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Philadelphia, Pennsylvania 19107
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4800 Friendship Avenue
Pittsburg, Pennsylvania 15224
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Santa Rosa, California 95403
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Springfield, Illinois 62703
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St. George, Utah 84770
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Tamarac, Florida 33321
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Wellington, Florida 33414
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Willemstad, Curacao
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