Status:
TERMINATED
A Comparative Efficacy Study: Treatment for Non-healing Diabetic Foot Ulcers
Lead Sponsor:
Integra LifeSciences Corporation
Conditions:
Foot Ulcer, Diabetic
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
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
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 followin...
Eligibility Criteria
Inclusion
- Major
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT01858545
Start Date
May 1 2013
End Date
December 1 2015
Last Update
April 15 2021
Active Locations (9)
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1
Carl t. Hayden Phoenix VA Medical Center
Phoenix, Arizona, United States, 85012
2
Associated Foot & Ankle Specialists, PC
Phoenix, Arizona, United States, 85015
3
Center for Clinical Research Inc.
Castro Valley, California, United States, 94546
4
Valley Vascular Surgery Associates
Fresno, California, United States, 93720