At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 11 enrolled
Drug / intervention
DermGENbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Feasibility Study of DermGEN Dermal Regeneration Scaffold for the Treatment of Diabetic Foot Ulcers
In Brief
A Phase 1 clinical trial evaluating DermGEN for Diabetes Type I and Diabetes Type II. Completed, enrolled 11 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Type I, Diabetes Type II
CountriesCanada
Timeline
Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 2014
Enrollment StartJul 2016
Primary CompletionMay 2017
TodayJul 2026
First PostedJul 9, 2014
Enrollment StartJul 1, 2016
Primary CompletionMay 1, 2017
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 12.0 years ago
Interventions
DermGENbiological
DermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue.