BR-AC + Standard Care for Diabetic Foot Ulcers

Not currently recruiting at 10 trial locations

Overseen By Nick McCoy

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: BioStem Technologies

Must not be taking: Steroids, Cytotoxic agents

Disqualifiers: HIV/AIDS, Cancer, Dialysis, Pregnancy, others

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding BioREtain® Amnion Chorion (BR-AC) to standard care improves the healing of diabetic foot ulcers compared to standard care alone. Participants will receive either the usual care treatments, such as cleaning and bandaging, or the same treatments plus BR-AC, a special product applied to the ulcer. If the ulcer does not heal after 12 weeks of standard care, participants may switch to the BR-AC treatment. The trial seeks individuals with Type 1 or Type 2 diabetes who have had a foot ulcer for more than four weeks but less than a year. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance future treatment options.

Will 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 who have used certain wound treatments or are on chronic oral steroids above a certain dose. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that BR-AC, a treatment for diabetic foot ulcers, was well-tolerated by patients in past studies. In these studies, patients using BR-AC rarely reported serious side effects. The treatment showed promise in helping wounds heal better than standard care alone.

This suggests that BR-AC is generally safe. However, like any treatment, it may carry risks. It's important to consult a healthcare provider to determine if this treatment is suitable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Unlike the standard care for diabetic foot ulcers, which involves methods like debridement and wound dressings, BR-AC is applied directly to the wound, possibly enhancing healing through its unique composition. Researchers are excited about BR-AC because it offers a new mechanism of action, potentially boosting the body's natural healing processes more effectively than current options. This targeted approach might lead to faster and more complete wound healing, reducing complications and improving patients' quality of life.

What evidence suggests that BR-AC plus standard care could be effective for diabetic foot ulcers?

Research has shown that BioRetain® Amnion Chorion (BR-AC) can improve healing in diabetic foot ulcers. One study found that using the BR-AC tissue transplant led to better healing results compared to standard care alone. In this trial, participants in one arm will receive BR-AC in addition to standard care, which uses a special membrane from the placenta to support the body's natural healing. Specifically, that study showed that patients experienced better healing with BR-AC for diabetic foot ulcers. These findings suggest that BR-AC could be a promising addition to standard wound care for improved ulcer healing. ^{2 3 4 6 7}

Who Is on the Research Team?

Bert Slade, MD

Principal Investigator

Independent

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My ulcer has been present for more than 4 weeks but less than a year.

My foot ulcer is shallow, without exposed muscle or bone.

Patient has signed the informed consent form

Exclusion Criteria

Hemoglobin A1c (HbA1c) level is > 12% (108 mmol/mol)

Any previous use of Vendaje, Vendaje AC, AmnioWrap2 applied to the target ulcer

I have gangrene on part of my foot.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either standard care or BR-AC plus standard care for diabetic foot ulcers

12 weeks

Weekly visits

Crossover Treatment

Participants who did not achieve complete wound closure with standard care crossover to receive BR-AC for additional treatment

12 weeks

Weekly visits

Follow-up

Participants are monitored for the longevity and durability of wound closure

4 weeks

2 visits (in-person) at two-week intervals

What Are the Treatments Tested in This Trial?

Interventions

• BR-AC

Trial Overview 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.

How Is the Trial Designed?

Group I: BR-AC plus Standard Care Experimental Treatment 1 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 Care Placebo Group 1 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.

Who Is Running the Clinical Trial?

BioStem Technologies

Lead Sponsor

Trials

4

Recruited

280+

Published Research Related to This Trial

Human amniotic membrane (HAM) allograft significantly improves the healing of chronic diabetic foot ulcers (DFUs), with a healing rate 3.88 times higher than standard care alone at 6 weeks and 2.01 times higher at 12 weeks, based on a meta-analysis of 7 studies involving 465 participants.

Patients receiving HAM treatment experienced a shorter time to complete healing by an average of 30.33 days, with no significant increase in adverse events, indicating that HAM is both effective and safe for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human amniotic membrane allograft, a novel treatment for chronic diabetic foot ulcers: A systematic review and meta-analysis of randomised controlled trials. Su, YN., Zhao, DY., Li, YH., et al.[2021]

In a study of 11 patients with chronic diabetic foot ulcers (DFUs) who did not heal with standard care, the addition of dehydrated human amniotic membrane (dHAM) treatment led to a significant increase in healing rates, with 91% achieving complete healing by 12 weeks.

Patients treated with dHAM showed an average wound size reduction of 87.6% after 4 weeks, compared to only 26.8% with standard care alone, indicating that dHAM can greatly enhance healing outcomes for difficult-to-treat DFUs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of dehydrated human amniotic membrane allografts in patients with DFUs. Zelen, CM.[2022]

The use of amniotic membrane for treating diabetic foot ulcers (DFUs) significantly increased the rate of wound healing, with patients healing 2.32 times more often and 32 days faster compared to those using conventional dressings, based on a meta-analysis of six clinical trials involving 331 patients.

While the amniotic membrane showed promising results in terms of healing speed and frequency, there was no statistical evidence to suggest it was more effective than other conventional dressings, indicating that further research is needed to fully establish its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biological effects of amniotic membrane on diabetic foot wounds: a systematic review. Paggiaro, AO., Menezes, AG., Ferrassi, AD., et al.[2023]

The use of human amnion/chorion membrane in conjunction with standard therapy significantly improves healing rates for diabetic foot ulcers (DFUs), with a marked reduction in incomplete healing wounds compared to standard care alone, as shown in a meta-analysis of seven randomized controlled trials involving 352 initial studies.

Optimal assessment times for evaluating wound healing progress with amnion treatment are at 4 weeks and 12 weeks, indicating that early and later evaluations are crucial for understanding treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Time Sensitivity of Amniotic Membrane treatment in Patients with Diabetic Foot Ulcers: A Systematic Review and Meta-analysis. Laurent, I., Astère, M., Wang, KR., et al.[2020]

In a study of 63 patients with diabetes and chronic foot ulcers, 40% of the ulcers closed after 12 weeks of treatment with a chorioamniotic allograft, with smaller ulcers showing better closure rates (57% for small ulcers compared to 10% for large ulcers).

The treatment was found to be safe, with no unexpected adverse events reported, supporting its use as a wound cover for chronic foot ulcers in patients with diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human placental membrane as a wound cover for chronic diabetic foot ulcers: a prospective, postmarket, CLOSURE study. Pacaccio, DJ., Cazzell, SM., Halperin, GJ., et al.[2019]

Using dehydrated human amnion/chorion membrane (DHACM) for treating lower extremity diabetic ulcers (LEDUs) significantly reduced the number of amputations and healthcare utilization compared to standard care, based on a study of over 1.2 million Medicare patients.

DHACM treatment not only improved clinical outcomes, providing an additional 0.013 quality-adjusted life years (QALYs) but also saved $3,670 per patient in the first year, indicating it is a cost-effective option for managing LEDUs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of dehydrated human amnion/chorion membrane allografts in lower extremity diabetic ulcer treatment. Tettelbach, WH., Armstrong, DG., Chang, TJ., et al.[2022]

Human amnion/chorion membrane therapy significantly improves healing rates for diabetic foot ulcers compared to standard therapy, with a notable increase in healing rates at 6, 12, and 16 weeks, and it also reduces the time to healing.

The therapy has a favorable safety profile, showing no significant increase in adverse events compared to standard treatment, indicating it is a safe option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of human amnion/chorion membrane therapy for diabetic foot ulcers: An updated meta-analysis of randomized clinical trials. Huang, W., Chen, Y., Wang, N., et al.[2021]

Citations

1. ir.biostemtechnologies.com ir.biostemtechnologies.com/biostem-technologies-completes-enrollment-in-clinical-trial-evaluating-bioretain-amnion-chorion-for-treatment-of-diabetic-foot-ulcers/

BioStem Technologies Completes Enrollment in Clinical ... We continue to enroll patients in two additional studies targeting venous leg ulcers using BR-AC and diabetic foot ulcers using BR-A. Both ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11183911/

Assessing placental membrane treatment efficiency in ... The findings suggest that while L‐AC might be slightly more effective in complete ulcer healing, RE‐AC offers overall better treatment efficiency.

3. biospace.com biospace.com/press-releases/biostem-technologies-reports-positive-top-line-clinical-results-demonstrating-superior-outcomes-with-bioretain-allograft-in-diabetic-foot-ulcers

BioStem Technologies Reports Positive Top-Line Clinical ... BioStem Technologies Reports Positive Top-Line Clinical Results Demonstrating Superior Outcomes with BioRetain® Allograft in Diabetic Foot ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06511596?term=biostem&rank=2

A Prospective Trial of Non-healing Diabetic Foot Ulcers ... This trial is a multicenter, randomized, controlled study designed to evaluate the safety and efficacy of BioREtain® Amnion Chorion (BR-AC) plus standard of ...

5. globenewswire.com globenewswire.com/news-release/2025/10/31/3178220/0/en/BioStem-Technologies-Reports-Positive-Top-Line-Clinical-Results-Demonstrating-Superior-Outcomes-with-BioRetain-Allograft-in-Diabetic-Foot-Ulcers.html

BioStem Technologies Reports Positive Top-Line Clinical BioStem Technologies Reports Positive Top-Line Clinical Results Demonstrating Superior Outcomes with BioRetain® Allograft in Diabetic Foot ...

6. ir.biostemtechnologies.com ir.biostemtechnologies.com/biostem-technologies-reports-positive-top-line-clinical-results-demonstrating-superior-outcomes-with-bioretain-allograft-in-diabetic-foot-ulcers/

BioStem Technologies Reports Positive Top-Line Clinical ... BioStem Technologies Reports Positive Top-Line Clinical Results Demonstrating Superior Outcomes with BioRetain® Allograft in Diabetic Foot ...

7. internationaljournaloftissuerepair.com internationaljournaloftissuerepair.com/index.php/ijtr/article/view/30

A prospective, multicenter, randomized, controlled trial of ... With only a 3.2% probability that BR-AC is not superior to SOC, these results provide strong evidence of treatment benefit. Author Biographies.