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Dehydrated Human Umbilical Cord Allograft in the Management of Diabetic Foot Ulcers

Diabetic Foot Ulcers Clinical Trial

Official title:
A Multicenter, Prospective, Randomized, Controlled, Comparative Parallel Study of Dehydrated Human Umbilical Cord Allograft in the Management of Diabetic Foot Ulcers

Clinical Trial 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)

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02844660
Study type Interventional
Source MiMedx Group, Inc.
Contact
Status Completed
Phase N/A
Start date July 2016
Completion date July 2018
View Details
See also
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