This trial is a multicenter, randomized, controlled study designed to evaluate the safety and efficacy of BioREtain® Amniotic Membrane (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-AM product following the protocol and procedures set forth within this document.
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 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
72
BR-AM is a single-layer amniotic membrane allograft. BR-AM is manufactured by BioStem Technologies, Inc. and is processed by the bioREtain method which, briefly, includes initial disinfection, processing with isotonic solutions, dehydration at 37-40°C and electron beam sterilization.
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.
Site 17
Guntersville, Alabama, United States
Site 22
Mesa, Arizona, United States
Site 25
Tucson, Arizona, United States
Site 19
Palmdale, California, United States
Site 02
San Francisco, California, United States
Site 01
Vista, California, United States
Site 27
Coral Gables, Florida, United States
Site 20
Deerfield Beach, Florida, United States
Site 28
DeLand, Florida, United States
Site 23
Springfield, Illinois, United States
...and 7 more locations
To determine whether DFUs treated with standard care plus BR-AM 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
Time frame: over the 12-week treatment period
To compare differences between treatment groups in proportions of wounds with complete wound closure, based on time in days to closure.
Percent change from baseline in wound surface area (cm2) at 12-weeks post-randomization.
Time frame: at 12 weeks
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.
Time frame: 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.
Time frame: at 12 weeks
To determine the total number of applications of BR-AM needed to achieve complete wound closure.
Total number of applications of BR-AM to achieve complete wound closure over 12-weeks post-randomization.
Time frame: over 12-weeks post-randomization
To determine whether subjects that crossover and receive standard care plus BR-AM results in a higher probability of achieving complete wound closure over the 12 additional weeks versus standard care alone based on time in days to closure.
Time in days 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.
Time frame: over an additional 12 weeks
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