Clinical Trial Evaluating an Amnion Membrane Allograft for Use in the Management of Non- Healing Diabetic Foot Ulcers Versus Standard Of Care (NCT06767501)
A Randomized Controlled Clinical Trial Evaluating The Efficacy of an Amnion Membrane Allograft Intended for Use in the Management of Non- Healing Diabetic Foot Ulcers Versus Standard Of Care Alone
๐ฉบ Plain-English Summary (8th-Grade Level)
The main purpose of this research study is to compare the proportion of wound closure in subjects that receive E-GRAFTโข with Standard of Care (SOC) versus FIBRACOLโข with SOC. Other research purposes include the following: * Rate of wound closure * Change in ulcer size over 12 weeks * Any adverse events or reactions (side effects) * Changes in neuropathy (nerve damage) * Change in pain levels * Occurrence of infection
Who can join: Review the eligibility criteria below.
Location: Professional Education and Research Institute โ Roanoke, Virginia
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (1 Sites)
- Professional Education and Research Institute โ Roanoke, Virginia
๐ Contact the Study Coordinator
Phone: (301) 471-8378
Email: aisaacdpm@gmail.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Diabetic Foot Ulcers (DFUs)
- PREPUP: A Randomized Trial of Bonvadisยฎ Versus Collagenase Ointment in Diabetic Foot Ulcers โ North Port, Florida
- Study of Miro3D Wound Matrix for Healing Wounds and Ulcers in Outpatient Care โ Coconut Creek, Florida
- Miro3D Wound Matrix for Treatment of Diabetic Foot Ulcers โ Phoenix, Arizona
- Miro3D Wound Matrix Study for Diabetic Foot Ulcers and Wound Healing โ Coconut Creek, Florida
Explore by condition: All Diabetic Foot Ulcers (DFUs) clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.