The primary objective of this study is to assess the effectiveness of cellular dermal replacement tissue vs. non-viable extracellular matrix (ECM) for the treatment of non-healing diabetic foot ulcers. Our hypothesis is that these devices are of equal efficacy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
SECONDARY dressing gauze and tape
debridement, irrigation
Dermagraft per company protocol
VA Northern California Health Care System, Mather, CA
Sacramento, California, United States
Wound Closure by Week 15
The primary outcome of interest is defined as the wound healed completely on or before visit 15, regardless of a later recurrence.
Time frame: 15 weeks
Wound Closure at 20 Weeks
Complete wound closure at study endpoint. The Secondary outcome of interest is defined as the wound healed completely on or before visit 19, regardless of a later recurrence. The number of subjects analyzed at secondary outcome differs from primary outcome due to some subjects not completing the study.
Time frame: 20 weeks
Cost Effectiveness
Time frame: 12 weeks
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Oasis per company protocol