BR-AM for Diabetic Foot Ulcer

Recruiting at 16 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

Trial Summary

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 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. ^{1 2 3 4 5}

Is BR-AM safe for treating diabetic foot ulcers?

Research shows that treatments using human amniotic membrane, like BR-AM, are generally safe for people with diabetic foot ulcers, with no significant difference in adverse events compared to standard care. ^{1 4 6 7 8}

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. ^{1 2 3 4 5}

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.

Research Team

Bert Slade, MD

Principal Investigator

Independent

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

Systematic review on the rational use of amniotic membrane allografts in diabetic foot ulcer treatment. [2021]

3. United States 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. [2020]

4. Spain pubmed.ncbi.nlm.nih.gov

Amniotic membrane transplantation in the treatment of chronic lower limb ulcers. [2012]

5. England pubmed.ncbi.nlm.nih.gov

Biological effects of amniotic membrane on diabetic foot wounds: a systematic review. [2023]

6. Switzerland 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. [2023]

7. United States 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. [2021]

8. England 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. [2021]