Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06565156
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Non-healing Diabetic Foot Ulcers Treated With Standard Care With or Without BR-AM
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Multicenter Randomized Controlled Trial of Non-healing Diabetic Foot Ulcers Treated With Standard Care With or Without BR-AM
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial is a multicenter randomized controlled study designed to evaluate the safety and efficacy of BR-AM 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 offloading 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
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
Detailed Description:
This study examines a patient population with a diabetic foot ulcer DFU having adequate perfusion without clinical signs and symptoms of infection Historical data has demonstrated that around 30 of DFUs heal within 12 weeks using standard care alone However roughly half of patients suffering from DFUs require additional measures including advanced therapy It is hypothesized that weekly applications of the human placental allograft BR-AM Vendaje applied to a nonhealing DFU will result in a higher rate of wounds showing complete healing within 12 weeks of initiating therapy compared to standard care alone
This study has a crossover period where subjects on standard care alone who do not achieve complete healing within 12 weeks of initiating therapy will be allowed to crossover to receive BR-AC over 12 additional weeks to evaluate if their wound can achieve complete healing
A follow-up phase will commence for all subjects that achieve complete wound closure which is designed to measure longevity and durability of the closed wound This follow up period will consist of a four-week follow up with two visits at each two-week interval
This study has a crossover period where subjects on standard care alone who do not achieve complete healing within 12 weeks of initiating therapy will be allowed to crossover to receive BR-AC over 12 additional weeks to evaluate if their wound can achieve complete healing
A follow-up phase will commence for all subjects that achieve complete wound closure which is designed to measure longevity and durability of the closed wound This follow up period will consist of a four-week follow up with two visits at each two-week interval
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None