Study of E-GRAFT™ for Diabetic Foot Ulcers

This study is looking at how well a product called E-GRAFT™ helps heal diabetic foot ulcers (DFUs) compared to another dressing called FIBRACOL™. Both treatments will be given along with standard care. We want to see if E-GRAFT™ leads to more ulcers healing completely after 12 weeks. Researchers will also track how quickly ulcers close, changes in their size, any side effects, changes in nerve damage or pain, and if infections occur. You might be able to join if you are at least 18 years old, have type 1 or 2 diabetes, and have a diabetic foot ulcer between 1.0 and 10.0 square centimeters in size. The study is currently recruiting about 100 participants.

Study design
This study compares two groups of participants, with one group receiving E-GRAFT™ and the other receiving FIBRACOL™, both with standard care. It aims to enroll 100 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 12 weeks to assess ulcer healing.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06767501

Clinical Trial Evaluating an Amnion Membrane Allograft for Use in the Management of Non- Healing Diabetic Foot Ulcers Versus Standard Of Care

Recruiting
NAAges 18+InterventionalTreatment
Skye Biologics Holdings, LLC
~100 participants
Updated 2025-01-10 on ClinicalTrials.gov
What's tested:E-GRAFT ™FIBRACOL™

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Comparison of the proportion of index ulcers "healed" at 12-weeks
Measured over 12-weeks
Diabetic Foot Ulcers (DFUs)
1 sites across 1 states
Virginia1
  • Charles M Zelen, DPM FACFAS · PRINCIPAL_INVESTIGATOR · Professional Education and Research Institute

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  • Comparison of the proportion of index ulcers "healed" at 12-weeks12-weeks

    Investigator assessment of healing (100% epithelization w/no drainage), measurements of ulcer size using manual measurements