NCT02184455

Feasibility Study of DermGEN for Diabetic Foot Ulcer Treatment

A Feasibility Study of DermGEN Dermal Regeneration Scaffold for the Treatment of Diabetic Foot Ulcers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Dr. Paul F. Gratzer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical trial is to perform a limited pilot study to determine the safety and feasibility of DermGEN in the treatment of non-healing diabetic foot ulcers (DFU). This will be a one-arm prospective study. It is hypothesized that DermGEN treatment will result in positive healing outcomes with no significant adverse effects.

Detailed description

This will be a one-arm prospective study. This study in Halifax will be mirrored in one other participating health care center in Toronto, Ontario, Canada with each centre anticipated to enrol 5-10 patients for a total of 15-20 patients.

Conditions

• Diabetes Type I
• Diabetes Type II

Interventions

Type	Name	Description
BIOLOGICAL	DermGEN	DermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue.

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2014-07-09
• Last updated: 2019-09-24
• Results posted: 2019-09-16

Locations

2 sites across 1 country: Canada