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Feasibility Study of DermGEN for Diabetic Foot Ulcer Treatment

NCT02184455 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2019-09-24

Study results available
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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.

Conditions

  • Diabetes Type I
  • Diabetes Type II

Interventions

BIOLOGICAL

DermGEN

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

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Nova Scotia Health Authority

    collaborator OTHER

  • Dr. Paul F. Gratzer

    lead INDUSTRY

Principal Investigators

  • Mark Glazebrook, PhD,MD · Queen Elizabeth II Health Sciences Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-01
Primary Completion
2017-05-01
Completion
2017-05-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02184455 on ClinicalTrials.gov