BR-AM for Diabetic Foot Ulcer
Recruiting in Palo Alto (17 mi)
+15 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: BioStem Technologies
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?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.
How is the BR-AM treatment different from other treatments for diabetic foot ulcers?
BR-AM (Vendaje, BioREtain Amniotic Membrane) is unique because it uses the amniotic membrane, which has properties that help heal wounds by reducing inflammation and promoting tissue growth. This treatment is different from standard care as it provides a biological scaffold that supports the body's natural healing process without causing an immune response.
12347What data supports the effectiveness of the treatment BR-AM for Diabetic Foot Ulcer?
Research shows that using amniotic membrane, a part of the BR-AM treatment, can help heal diabetic foot ulcers by protecting the wound and promoting healing. Studies have found it effective in treating these ulcers, which are difficult to heal with standard care.
12347Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it excludes those using certain treatments like chronic oral steroids, cytotoxic agents, and specific wound treatments within 30 days before screening. It's best to discuss your current medications with the trial team to see if they are allowed.
Eligibility Criteria
This trial is for adults 18+ with Type 1 or Type 2 Diabetes who have a chronic diabetic foot ulcer located below the ankle, sized between 1.0 and 20.0 cm², and not involving muscle, tendon, bone exposure (Wagner Grade I or II). The ulcer should be hard-to-heal, existing for more than four weeks but less than one year. Participants must have adequate blood flow to the foot and sign informed consent.Inclusion Criteria
I am 18 years old or older.
I have been diagnosed with Type 1 or Type 2 Diabetes.
I have a foot ulcer below my ankle, sized 1 to 20 cm2, measured after cleaning.
My foot ulcer is shallow, without exposed muscle or bone.
Participant Groups
The study compares two approaches: standard wound care alone versus standard care plus BR-AM treatment in healing diabetic foot ulcers. It's randomized and controlled; some patients may switch from just standard care to also receiving BR-AM after an initial phase if their wounds don't heal.
2Treatment groups
Experimental Treatment
Active Control
Group I: BR-AM 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-AM should be applied directly to the wound surface following sharp debridement. It is recommended that the product be trimmed to fit the area of the wound with sterile scissors before application.
Group II: Standard CareActive Control1 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.
BR-AM is already approved in United States for the following indications:
🇺🇸 Approved in United States as Vendaje for:
- Diabetic foot ulcers
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Site 19Palmdale, CA
Site 13Torrance, CA
Site 20DeLand, FL
Site 15Chapel Hill, NC
More Trial Locations
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Who is running the clinical trial?
BioStem TechnologiesLead Sponsor
References
Amniotic membrane transplantation in the treatment of chronic lower limb ulcers. [2012]Approximately 1% of the general population have venous or arterial lower limb ulcers. These lesions can be treated with biological skin substitutes such as cadaver skin or tissue-engineered skin equivalents, but treatment fails in 25% of cases, resulting in pain and loss of patient autonomy, as well as increased morbidity and health care costs. In the treatment of corneal ulcers, amniotic membrane has been shown to have antimicrobial and bacteriostatic properties, and to protect the wound without eliciting an immune response. The same properties have been reported in the treatment of burns and postthrombotic ulcers.
An evaluation of dehydrated human amniotic membrane allografts in patients with DFUs. [2022]To evaluate healing of chronic diabetic foot ulcers (DFUs) with use of dehydrated human amniotic membrane (dHAM) in patients failing under standard of care treatment.
Efficacy and Time Sensitivity of Amniotic Membrane treatment in Patients with Diabetic Foot Ulcers: A Systematic Review and Meta-analysis. [2020]Diabetic foot ulcers (DFUs) are complex chronic wounds which have a major long-term impact on the morbidity, mortality and quality of patients. The objective of this study was to assess the efficacy and time sensitivity of human amnion/chorion membrane treatment in patients with chronic DFUs.
Biological effects of amniotic membrane on diabetic foot wounds: a systematic review. [2023]The amniotic membrane has biological properties that are beneficial to the wound healing process of diabetic foot ulcers (DFU). Our aim is to analyse the scientific evidence found in literature on the use of the amniotic membrane to stimulate DFU healing.
Human amniotic membrane allograft, a novel treatment for chronic diabetic foot ulcers: A systematic review and meta-analysis of randomised controlled trials. [2021]To evaluate the efficacy and safety of human amniotic membrane (HAM) allograft in treating chronic diabetic foot ulcers (DFUs), a comprehensive search of randomised controlled trials in MEDLINE, EMBASE, PubMed, CENTRAL and Web of Science was conducted to December 7, 2019. Two reviewers independently screened the studies, extracted data, and evaluated the quality of studies. The primary outcome was the proportion of complete healing. The secondary outcomes were mean time to complete healing and adverse events. Statistical analyses were performed using RevMan 5.3. We identified 257 articles, of which 7 articles (465 participants) were included in the meta-analysis. The proportion of complete wound healing in HAM plus standard of care (SOC) group was 3.88 times as high as that in SOC alone (RR: 3.88 [95% CI: 2.34, 6.44]) at 6 weeks, and 2.01 times at 12 weeks (RR: 2.01 [95%CI: 1.45, 2.77]). The intervention group had a significantly shorter time to complete healing (MD: -30.33 days, [95% CI: -37.95, -22.72]). The number needed to treat within 6 weeks was 2.3 ([95% CI: 1.8, 3.1]). No significant difference was shown in adverse events. Results were consistent in a sensitivity analysis. Hence, HAM plus SOC is effective and safe in treating chronic DFUs.
Effectiveness and safety of human amnion/chorion membrane therapy for diabetic foot ulcers: An updated meta-analysis of randomized clinical trials. [2021]Human amnion/chorion membrane therapy has shown advantages in the management of diabetic foot ulcers and its effectiveness has been evaluated in the systematic reviews and meta-analyses. However, the number of patients included in the previous literatures was small and the safety profile of human amnion/chorion membrane therapy was not concerned. Therefore, we conducted an updated meta-analysis to better understand the effectiveness and safety of human amnion/chorion membrane therapy for diabetic foot ulcers. The PubMed, Embase, Cochrane Library, and ClinicalTrial.gov databases were searched for any randomized clinical trials comparing human amnion/chorion membrane therapy and standard therapy in the treatment of diabetic foot ulcers. Ulcer healing rate was considered as the primary outcome and the secondary outcomes mainly included mean time to ulcer healing and adverse events. Nine RCTs with 541 patients were included. Compared with merely standard therapy, human amnion/chorion membrane therapy plus standard therapy improved the ulcer healing rates at 6 weeks (RR = 3.50, 95% CI: 2.35-5.21), 12 weeks (RR = 2.09, 95% CI: 1.53-2.85) and 16 weeks (RR = 1.70, 95% CI: 1.25-2.30), and also shortened the healing time (MD = -4.58, 95% CI: -5.70 to -3.46). Meanwhile, no significant difference was observed in the number of patients with adverse events (RR = 0.56, 95% CI: 0.31-1.03) between two groups. This meta-analysis suggests that human amnion/chorion membrane therapy as an adjuvant treatment could promote the healing of diabetic foot ulcers and has a safety profile. More evidence from large high-quality randomized clinical trials with long follow-up duration are in urgent need to further confirm our findings.
Systematic review on the rational use of amniotic membrane allografts in diabetic foot ulcer treatment. [2021]Diabetic foot ulcer is a complication with multiple aetiological factors which has a significant impact to patients' lives and costs to the healthcare system. The potential of human amniotic membrane to act as an allograft has been studied in relation to this condition. Aim of this study is to evaluate the current scientific evidence on its effectiveness in healing diabetic foot ulcers.
Evaluation of the effect of a gel made with amniotic fluid formulation on the healing of diabetic foot ulcers: A triple-blind clinical trial. [2023]The aim of this study was to evaluate the effect of a gel made with amniotic fluid (AF) formulation on wound healing in diabetic foot ulcers.