BR-AC + Standard Care for Diabetic Foot Ulcers

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

60 Participants Needed

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® Amnion Chorion (BR-AC) 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 off-loading. 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-AC product following the protocol and procedures set forth within this document.

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.

What data supports the effectiveness of the treatment BR-AC, BioREtain - Amnion Chorion, AmnioWrap2 for diabetic foot ulcers?

Research shows that using human amnion/chorion membrane therapy along with standard care significantly improves the healing rates of diabetic foot ulcers and shortens the healing time, without increasing adverse events. This suggests that the treatment is effective and safe for managing these ulcers. ^{1 2 3 4 5}

Is the treatment BR-AC (BioREtain - Amnion Chorion) safe for use in humans?

Research shows that using human amnion/chorion membrane therapy, like BR-AC, for diabetic foot ulcers is generally safe, with no significant difference in adverse events compared to standard care. ^{2 3 4 5 6}

How is the BR-AC treatment different from other treatments for diabetic foot ulcers?

BR-AC treatment uses a special membrane from the human placenta, which can help diabetic foot ulcers heal faster and more effectively than standard care alone. This treatment is unique because it combines the natural healing properties of the amnion and chorion membranes, which are not typically used in standard treatments. ^{1 3 4 5 7}

Research Team

Bert Slade, MD

Principal Investigator

Independent

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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]

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]

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 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]

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]

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]

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]

References

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

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

2. 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]

3. 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]

4. England pubmed.ncbi.nlm.nih.gov

Human placental membrane as a wound cover for chronic diabetic foot ulcers: a prospective, postmarket, CLOSURE study. [2019]

5. 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]

6. England pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of dehydrated human amnion/chorion membrane allografts in lower extremity diabetic ulcer treatment. [2022]