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 |
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.
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
sites
4502 Medical Drive
San Antonio, Texas 78284
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials