NCT02844660

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: MiMedx Group, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Foot Ulcers

Interventions

Type	Name	Description
BIOLOGICAL	EpiCord	Weekly application of EpiCord and standard of care (moist wound therapy and offloading)
OTHER	Standard of Care	moist wound therapy and offloading

Timeline

• Start date: 2016-07-01
• Primary completion: 2018-07-01
• Completion: 2018-07-01
• First posted: 2016-07-26
• Last updated: 2022-05-13

Locations

13 sites across 1 country: United States