BR-AM for Diabetic Foot Ulcer

Recruiting at 18 trial locations

Overseen By Nick McCoy

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: BioStem Technologies

Must not be taking: Steroids, Cytotoxic agents, Antimicrobials, others

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of BioREtain® Amniotic Membrane (BR-AM) alongside standard care in healing diabetic foot ulcers. Diabetic foot ulcers are persistent sores on the feet of individuals with diabetes that can be difficult to heal. Participants will receive either standard care or standard care plus BR-AM, which is applied directly to the wound to aid healing. Individuals with diabetes who have a long-lasting foot ulcer below the ankle that hasn't healed in over a month may be suitable for this trial. The study also allows those who initially receive only standard care to try the new treatment if their ulcer does not heal after 12 weeks. As an unphased trial, this study provides patients the opportunity to explore a new treatment option that could improve healing outcomes.

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 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.

What prior data suggests that the BioREtain Amniotic Membrane is safe for treating diabetic foot ulcers?

Research shows that treatments like BR-AM, which use human amniotic membrane, are usually well-tolerated for healing diabetic foot ulcers. Previous studies have demonstrated significantly better wound healing with these treatments compared to standard methods, indicating their safety and effectiveness for many patients.

Specific details on side effects for BR-AM are not available, but its inclusion in a clinical trial suggests earlier research found it safe. Additionally, amniotic membrane treatments are already used for other health issues, providing some confidence in BR-AM's safety for most people. As always, discussing any concerns with a healthcare team before joining a trial is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about BR-AM for diabetic foot ulcers because it offers a unique approach compared to standard care. Unlike traditional treatments that primarily focus on wound management with dressings and devices, BR-AM is applied directly to the wound, potentially enhancing healing by directly interacting with the tissue. This targeted application is thought to accelerate healing and improve outcomes by optimizing the wound environment. This promising method could revolutionize how we treat diabetic foot ulcers, making healing faster and more effective.

What evidence suggests that BR-AM might be an effective treatment for diabetic foot ulcers?

Research has shown that BR-AM, a type of amniotic membrane, may aid in healing diabetic foot ulcers. In this trial, one group of participants will receive BR-AM alongside standard care. One study found that BR-AM helped wounds close more effectively than standard treatment alone. Another study demonstrated that using BR-AM led to better healing, with only a 3.2% chance that it wasn't more effective than regular treatment. These findings suggest that adding BR-AM to standard care could enhance the likelihood of complete ulcer healing. ^{1 2 6 7 8}

Who Is on the Research Team?

Bert Slade, MD

Principal Investigator

Independent

Are You a Good Fit for This Trial?

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

My ABI measurement is between 0.70 and 1.20.

My foot's oxygen level is adequate.

I have signed the informed consent form.

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-AM 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-AM for additional treatment

12 weeks

Weekly visits

Follow-up

Participants are monitored for the longevity and durability of the closed wound

4 weeks

2 visits at two-week intervals

What Are the Treatments Tested in This Trial?

Interventions

• BR-AM

Trial Overview 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.

How Is the Trial Designed?

Group I: BR-AM 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-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 Care Active Control 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.

BR-AM is already approved in United States for the following indications:

Approved in United States as Vendaje for:

• Diabetic foot ulcers

Who Is Running the Clinical Trial?

BioStem Technologies

Lead Sponsor

Trials

4

Recruited

280+

Published Research Related to This Trial

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]

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]

Human amniotic membrane allografts have shown a significantly higher wound closure rate in diabetic foot ulcers compared to conventional treatments, based on a review of 12 studies including 8 randomized control trials.

Despite variations in study methods and outcomes, the evidence suggests that amniotic membrane can effectively reduce healing time for chronic ulcers that do not respond to standard therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review on the rational use of amniotic membrane allografts in diabetic foot ulcer treatment. Lakmal, K., Basnayake, O., Hettiarachchi, D.[2021]

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]

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]

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]

A clinical trial involving 92 type 2 diabetic patients demonstrated that a gel made from amniotic fluid significantly improved wound healing in diabetic foot ulcers compared to a placebo, with notable differences in wound grade and healing duration after eight weeks.

The study suggests that amniotic fluid gel is a safe and effective treatment option for chronic diabetic foot ulcers, highlighting its potential as a beneficial therapeutic intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the effect of a gel made with amniotic fluid formulation on the healing of diabetic foot ulcers: A triple-blind clinical trial. Niami, F., Molavynejad, S., Hemmati, AA., et al.[2023]

Amniotic membrane transplantation showed promising results in treating refractory chronic leg ulcers, with complete re-epithelialization achieved in one case by week 8 and an average wound size reduction of 81.93% by week 16 across four ulcers.

The treatment also significantly reduced pain intensity by 86.6% without any observed adverse effects, suggesting it is a safe and effective alternative for patients with difficult-to-treat ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amniotic membrane transplantation in the treatment of chronic lower limb ulcers. Alsina-Gibert, M., Pedregosa-Fauste, S.[2012]

Citations

1. 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.

2. ir.biostemtechnologies.com ir.biostemtechnologies.com/biostem-technologies-reports-breakthrough-results-in-a-diabetic-foot-ulcer-wound-closure-study-comparing-bioretain-to-standard-of-care-treatment/

BioStem Technologies Reports Breakthrough Results in a ... In this study, researchers conducted a retrospective analysis to evaluate the effectiveness of a sterile, dehydrated amnion/chorion membrane ...

3. dermatologytimes.com dermatologytimes.com/view/biostem-launches-br-am-dfu-clinical-trial-for-non-healing-diabetic-foot-ulcers

BioStem Launches BR-AM-DFU Clinical Trial for Non- ... The novel study will evaluate the standard of care treatment with and without Vendaje, aiming to demonstrate its superiority in advanced wound care.

4. biospace.com biospace.com/press-releases/biostem-technologies-launches-clinical-trial-to-demonstrate-the-therapeutic-benefits-of-its-bioretain-technology-in-treating-diabetic-foot-ulcers-using-vendaje

BioStem Technologies Launches Clinical Trial to ... The BR-AM-DFU trial is a multicenter, randomized, controlled study that will enroll 60 patients with non-healing DFUs at approximately twelve sites across the ...

5. 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.

6. ir.biostemtechnologies.com ir.biostemtechnologies.com/biostem-technologies-launches-clinical-trial-to-demonstrate-the-therapeutic-benefits-of-its-bioretain-technology-in-treating-diabetic-foot-ulcers-using-vendaje/

BioStem Technologies Launches Clinical Trial to ... The BR-AM-DFU trial is a multicenter, randomized, controlled study that will enroll 60 patients with non-healing DFUs at approximately twelve sites across the ...

7. 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 ...

8. withpower.com withpower.com/trial/br-am-for-diabetic-foot-ulcer-93988

BR-AM for Diabetic Foot Ulcer Human amniotic membrane allografts have shown a significantly higher wound closure rate in diabetic foot ulcers compared to conventional treatments, based on a ...