Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06511596 · ClinicalTrials.gov registry record · NA
A Prospective Trial of Non-healing Diabetic Foot Ulcers Treated With Standard Care With or Without BR-AC
A NA study, sponsored by BioStem Technologies.
- Completed
- Registry status
- NA
- Development phase
- 71
- Enrollment target
NCT06511596 is a NA study that has completed, run by BioStem Technologies. The registered enrollment target is 71 participants.
The verdict
NCT06511596, a NA study, has completed, sponsored by BioStem Technologies.
- COMPLETED
- Registry status
- NA
- Development phase
- 71 participants
- Enrollment target
Study Summary
This trial is a multicenter, randomized, controlled study designed to evaluate the safety and efficacy of BioREtain® Amnion Chorion (BR-AC) plus standard of care versus standard of care only in the treatment of diabetic foot ulcers. The trial design will control potential variables that may affect the outcome between the treatment group and the control group by standardizing the requirements for debridement, wound dressings, and off-loading. Weekly subject visits will help monitor compliance in wound care and off-loading, as well as to document when wound closure is achieved. The study will also implement the use of an electronic imaging and measurement device using a standardized protocol to ensure the measuring of the wound surface area and volume is accurate, highly reproducible, and minimally variable. There will also be a crossover treatment phase for those patients that were relegated to standard care only. After their 12-week standard of care treatment phase and for only those subjects that did not achieve complete wound closure, will be allowed to crossover for an additional 12 weeks of treatment with the BR-AC product following the protocol and procedures set forth within this document.
Interventions
- OTHER Standard Care
- OTHER BR-AC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2024-09-03 |
| Est. Completion | 2025-12-22 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06511596
The ClinicalTrials.gov registry entry for NCT06511596 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioStem Technologies, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Standard Care is the first listed.
NCT06511596 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06511596 about?
NCT06511596 is a clinical study titled "A Prospective Trial of Non-healing Diabetic Foot Ulcers Treated With Standard Care With or Without BR-AC". This trial is a multicenter, randomized, controlled study designed to evaluate the safety and efficacy of BioREtain® Amnion Chorion (BR-AC) plus standard of care versus standard of care only in the treatment of diabetic foot ulcers. The trial design will control potential variables that may affect t...
What is the current status of trial NCT06511596?
This trial is currently completed. It is a NA study. The enrollment target is 71 participants. The study started on 2024-09-03. Estimated completion is 2025-12-22.
What interventions are being tested in trial NCT06511596?
The interventions under investigation include: Standard Care (OTHER), BR-AC (OTHER).
Who is sponsoring clinical trial NCT06511596?
This trial is sponsored by BioStem Technologies, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.