A Multicenter, Prospective, Randomized, Controlled, Comparative Parallel Study of Dehydrated Human Umbilical Cord Allograft in the Management of Diabetic Foot Ulcers
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetic Foot Ulcers
- Sponsor
- MiMedx Group, Inc.
- Enrollment
- 130
- Locations
- 13
- Primary Endpoint
- Study Safety Measurement
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
A Multicenter, Prospective, Randomized Controlled Comparative Parallel Study To determine the safety and effectiveness of EpiCord as compared to standard of care (SOC) therapy for the treatment of chronic, non-healing diabetic foot ulcers (DFUs)
Detailed Description
This is a prospective, multicenter, randomized controlled trial. The trial will include approximately 66 subjects in up to 10 experienced clinical centers in the United States. The estimated enrollment period is 18 weeks (this includes the 2-week run-in period). After completing a 2-week screening period, the subjects will be followed for at least 16 weeks post-randomization.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject has a known history of Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per ADA).
- •Index ulcer characteristics:
- •a. Ulcer present for ≥ 30 days prior to randomization (Day 0) b. Index ulcer is located below the ankle c. Index ulcer area after debridement is ≥ 1 cm² and ≤ 15 cm² at the randomization visit
- •Subject has completed 14-day run-in period with ≤ 30% wound area reduction post-debridement.
- •Subject has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 60 days:
- •Dorsum transcutaneous oxygen test (TcPO2) with results ≥ 30 mmHg, OR
- •ABIs with results of ≥ 0.7 and ≤ 1.2, OR
- •Doppler arterial waveforms, which are triphasic or biphasic at the ankle of the affected foot
- •The subject is willing and able to provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study
- •Index Ulcer Assessment:
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Study Safety Measurement
Time Frame: 12 weeks
The proportion of product related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events at 12 weeks.
Complete Ulcer Closure
Time Frame: 12 weeks
The percentage of subjects with complete closure of the study ulcer as assessed by photographic evaluation
Secondary Outcomes
- Rate of wound closure(up to 12 weeks)
- Time to complete closure(up to 12 weeks)
- Incidence of ulcer recurrence(up to 12 weeks)
- Quality of Life Health Survey(up to 12 weeks)
- Quality of Life-Pain(up to 12 weeks)
- Cost effectiveness of treatment(up to 12 weeks)