A Prospective Trial of Non-healing Diabetic Foot Ulcers Treated With Standard Care With or Without BR-AC
NCT Number: NCT06511596
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetic Foot Ulcer
Interventions: OTHER: BR-AC|OTHER: Standard Care
Sponsor: BioStem Technologies
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-12
Locations: Site 02, San Francisco, California, 94115, United States|Site 04, Sylmar, California, 91342, United States|Site 07, Torrance, California, 90502, United States|Site 01, Vista, California, 92081, United States|Site 08, North Chicago, Illinois, 60064, United States|Site 06, O'Fallon, Illinois, 62269, United States|Site 10, Westwood, New Jersey, 07675, United States|Site 03, Fort Worth, Texas, 76104, United States|Site 09, Frisco, Texas, 75034, United States|Site 05, McAllen, Texas, 78501, United States

Summary:
This trial is a multicenter, randomized, controlled study designed to evaluate the safety and efficacy of 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 Measures: 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., 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., over the 12-week treatment period
Secondary Outcome Measures: To compare differences between treatment groups in proportions of wounds with complete wound closure, based on time in days to closure., Time in number of days to complete wound closure over the 12-week treatment period, starting from baseline to the time of initial observation of wound closure., over the 12-week treatment period|To compare differences between treatment groups in percent change in wound area (cm2)., Percent change from baseline in wound surface area (cm2) at 12-weeks post-randomization., at 12 weeks|To compare differences between treatment groups in percent change in wound volume (cm3)., Percent change from baseline in wound volume (cm3) at 12-weeks post-randomization., at 12 weeks|To determine the total number of applications of BR-AC needed to achieve complete wound closure., Total number of applications of BR-AC to achieve complete wound closure over 12-weeks post-randomization., over 12-weeks post-randomization|To determine whether subjects that crossover and receive standard care plus BR-AC results in a higher probability of achieving complete wound closure over the 12 additional weeks versus standard care alone., Time from Visit 18 to initial observation of wound closure (defined as 100% reepithelialization of the wound without drainage) over an additional 12 weeks (Visits 19-30), where healing has been confirmed at two visits two weeks apart., over an additional 12 weeks
Other Outcome Measures: DFUs that acquire clinical signs and symptoms of infections post-randomization, Differences in clinical signs and symptoms of infection from Visit 2 through end of study between the treatment groups, over 12-weeks post-randomization|Proportion of subjects experiencing adverse events, by treatment group, Spontaneously reported and elicited adverse events, coded in MedDRA, over the 17-week study period