NCT02587104

dHACM In the Treatment of Diabetic Foot Ulcers

A Single Center, Prospective, Non-Randomized, Historical Controlled Trial of dHACM In the Treatment of Diabetic Foot Ulcers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: MiMedx Group, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A single-centered, non-randomized study with approximately 20 subjects that will be seen for up to 12 weeks, each receiving the EpiFix plus standard of care. Safety and effectiveness will be monitored throughout the study.

Detailed description

Approximately 20 subjects will be enrolled in this study. Subjects will be seen for up to12 weeks unless 100% epithelialization of the index wound and two subsequent healing confirmation visits have been achieved prior to week 12. Each subject will receive a weekly application of the EpiFix plus standard of care until 100% epithelialization is achieved. The subjects will be evaluated for efficacy and safety during the course of the trial.

Conditions

• Diabetic Foot Ulcers

Interventions

Type	Name	Description
OTHER	EpiFix	Weekly application of EpiFix and standard of care (moist wound therapy and offloading)

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-05-01
• Completion: 2016-06-01
• First posted: 2015-10-27
• Last updated: 2017-08-25

Locations

1 site across 1 country: Canada