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BR-AC plus Standard Care for Foot Ulcer

N/A
Waitlist Available
Research Sponsored by BioStem Technologies
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Patient has signed the informed consent form.
* Male or female patient at least 18 years of age or older, as of the date of the screening visit.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over the 17-week study period
Awards & highlights

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.

Who is the study for?
This trial is for individuals with non-healing diabetic foot ulcers. Participants must be able to attend weekly visits and comply with wound care instructions. Details on specific inclusion or exclusion criteria are not provided, but typically these would involve factors like the severity of the ulcer, overall health status, and any other medical conditions that might affect healing.
What is being tested?
The study compares two approaches: one group receives BR-AC plus standard care (like cleaning and bandaging), while another gets just standard care. The goal is to see if adding BR-AC improves healing. Patients who don't heal in 12 weeks with standard care can switch to try BR-AC for another 12 weeks.
What are the potential side effects?
Specific side effects of BR-AC aren't listed here, but generally treatments for foot ulcers could cause skin irritation, infection risk increase due to immune response changes, or allergic reactions depending on the components of the treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over the 17-week study period
This trial's timeline: 3 weeks for screening, Varies for treatment, and over the 17-week study period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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.
Secondary study objectives
To compare differences between treatment groups in percent change in wound area (cm2).
To compare differences between treatment groups in percent change in wound volume (cm3).
To compare differences between treatment groups in proportions of wounds with complete wound closure, based on time in days to closure.
+2 more
Other study objectives
DFUs that acquire clinical signs and symptoms of infections post-randomization
Proportion of subjects experiencing adverse events, by treatment group

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BR-AC plus Standard CareExperimental Treatment1 Intervention
All subjects in the treatment group will receive sponsor-approved standard of care. Standard of care is defined as: * Debridement, * Wound cleansing with a neutral, non-irritating and non-toxic solution, * Non-adherent wound contact layer, a foam pad, alginate or hydrofiber dressing for moderately draining wounds, a secondary retention bandage, and * An off-loading device. Using an appropriate size to cover the entire wound area, BR-AC should be applied directly to the wound surface following sharp debridement w. It is recommended that the product be trimmed to fit the area of the wound with sterile scissors before application.
Group II: Standard CarePlacebo Group1 Intervention
All subjects in the control group will receive sponsor-approved standard of care. Standard of care is defined as: * Debridement, * Wound cleansing with a neutral, non-irritating and non-toxic solution, * Non-adherent wound contact layer, a foam pad, alginate or hydrofiber dressing for moderately draining wounds, a secondary retention bandage, and * An off-loading device.

Find a Location

Who is running the clinical trial?

BioStem TechnologiesLead Sponsor
2 Previous Clinical Trials
160 Total Patients Enrolled
2 Trials studying Foot Ulcer
160 Patients Enrolled for Foot Ulcer
Robert Frykberg, DPM, MPHStudy DirectorIndependent
1 Previous Clinical Trials
60 Total Patients Enrolled
1 Trials studying Foot Ulcer
60 Patients Enrolled for Foot Ulcer
~40 spots leftby Nov 2025
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