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: Completed NA study, sponsored by BioStem Technologies.
NCT06511596 is a NA study that has completed, run by BioStem Technologies. The registered enrollment target is 71 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Percentage of subjects with complete wound closure over the 12-week treatment period, defined as 100% reepithelialization of the wound without drainage, where healing has been confirmed at two visits two weeks apart.
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 |
What the finished NCT06511596 record still lists
NCT06511596 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard Care is the first listed.
NCT06511596 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT06511596's enrollment target sits among peer trials
71 1102nd of 2000 higher than 898 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05452889 · 71 participants · Early Phase 1
PET Image in PAH Patients
- NCT05766943 · 71 participants · NA
Reduction of Myopotential Interference With Smart Pass in S-ICD Patients
- NCT06229678 · 71 participants · Early Phase 1
Ketones, SGLT2, HFrEF
- NCT06377566 · 71 participants · Phase 2
A Study of BV-AVD in People With Bulky Hodgkin Lymphoma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI