Foot Ulcer, Diabetic Clinical Trial
Official title:
An Evaluation of Tissue Engineering Approaches for Treatment of Neuropathic Diabetic Foot Ulcers Resistant to Standard of Care: A Prospective, Randomized Controlled Trial
NCT number | NCT01858545 |
Other study ID # | ACL2011-002-I |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2013 |
Est. completion date | December 2015 |
Verified date | March 2021 |
Source | Integra LifeSciences Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 56 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Center for Clinical Research Inc. | Castro Valley | California |
United States | Denver VA Medical Center | Denver | Colorado |
United States | Valley Vascular Surgery Associates | Fresno | California |
United States | Advanced Research Institute of Miami | Homestead | Florida |
United States | NewPhase Clinical Trials, Corp. | Miami Beach | Florida |
United States | Associated Foot & Ankle Specialists, PC | Phoenix | Arizona |
United States | Carl t. Hayden Phoenix VA Medical Center | Phoenix | Arizona |
United States | Professional Health Care of Pinellas | Saint Petersburg | Florida |
United States | Georgetown University Medical Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Integra LifeSciences Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Complete Wound Closure | Number of participants with incidence of complete wound closure | 8 Weeks |
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