Calendario›BSEM›A Prospective Trial of Non-healing Diabetic Foot Ulcers Treated With Standard Care With or Without BR-AC
A Prospective Trial of Non-healing Diabetic Foot Ulcers Treated With Standard Care With or Without BR-AC
Ensayo de BioStem Technologies, Inc. en Ulcera de pie diabetico.
Más ensayos de: Úlcera de pie diabético.
- Fase
- Sin fase asignada
- Estado
- Completado
- Participantes
- 71
- Centros
- 11
- Fin del objetivo primario
- dic 2025
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, simple ciego. Comenzó en sep 2024.
Qué mide
To determine whether DFUs treated with standard care plus BR-AC results in a higher probability of achieving complete wound closure compared to standard care alone. (over the 12-week treatment period) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis 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.
Más ensayos de BSEM
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| Non-healing Venous Leg Ulcers Treated With Standard Care With or Without BR-AC | Sin fase asignada | En marcha, sin reclutar | ago 2026 (real) |
| Non-healing Diabetic Foot Ulcers Treated With Standard Care With or Without BR-AM | Sin fase asignada | Completado | nov 2025 (real) |
| Vendaje | Sin fase asignada | Retirado antes de empezar | dic 2024 (prevista, ya pasada: sin actualizar en el registro) |
Todos los de BSEM, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT06511596), actualizada en ene 2026.