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Treatment of non-healing diabetic foot ulcers with a new therapy

A Prospective, Multicenter, Randomized, Controlled Trial of Non-healing Diabetic Foot Ulcers Treated With Standard Care With or Without BR-AC

Not applicable Interventional BioStem Technologies · NCT06511596

This study is testing a new therapy called BioREtain® Amnion Chorion to see if it helps people with diabetic foot ulcers heal better than just using standard care alone.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment60 (estimated)
Ages18 Years and up
SexAll
SponsorBioStem Technologies Industry-sponsored
Locations11 sites (San Francisco, California and 10 other locations)
Trial IDNCT06511596 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, controlled trial evaluates the safety and efficacy of BioREtain® Amnion Chorion (BR-AC) combined with standard care versus standard care alone for treating diabetic foot ulcers. The study standardizes treatment protocols, including debridement and wound dressings, and employs weekly visits to monitor compliance and document healing progress. A crossover phase allows patients who do not heal with standard care to receive BR-AC after 12 weeks. Additionally, a follow-up phase assesses the durability of wound closure for those who achieve healing.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with Type 1 or Type 2 diabetes and chronic non-healing diabetic foot ulcers.

Not a fit: Patients with infected diabetic foot ulcers or those with inadequate arterial supply to the foot may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve healing rates for patients with chronic diabetic foot ulcers.

How similar studies have performed: Previous studies have shown that advanced therapies can improve healing rates in diabetic foot ulcers, suggesting potential success for this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Patient has signed the informed consent form.
* Male or female patient at least 18 years of age or older, as of the date of the screening visit.
* Confirmed diagnosis of Type 1 or Type 2 Diabetes.
* Has a DFU that is located below the malleoli at least 1.0 cm2 or up to 20.0 cm2 when measured by the investigator staff at the screening visit using the Tissue Analytics device post debridement.

  a. If more than one ulcer is present the selected target ulcer must be at least 2 cm from the nearest edge of any adjacent ulcers.
* The depth of the target foot ulcer is graded as Wagner Grade I or II, i.e., with no evidence of exposed muscle, tendon, bone, or joint capsule.
* The target ulcer is "chronic, hard-to-heal," defined as having a duration of \> 4 weeks but ≤ 52 weeks at the time of the screening visit.
* Arterial supply adequacy to the foot with the target ulcer confirmed by any one of the following:

  1. Great toe pressure ≥ 40 mm/Hg
  2. Systolic blood pressure Ankle Brachial Index (ABI) in the range ≥ 0.70 ≤ 1.20
  3. TcPO2 ≥ 30 mmHg from the foot
  4. Toe Brachial Index or TBI ≥ 0.50
* Willing to follow all instructions given by the Investigator, return for all visits, and adhere to off-loading protocols while on the study.

Exclusion Criteria:

* Hemoglobin A1c (HbA1c) level is \> 12% (108 mmol/mol).
* Chronic oral steroid use of \> 7.5 mg daily within the previous 30 days preceding screening.
* Chronic oral or parenteral corticosteroids, or any cytotoxic agents within the previous 30 days preceding screening.
* Has tested positive for Human Immunodeficiency Virus (HIV) or has Acquired Immune Deficiency Syndrome (AIDS).
* Has malignancy or history of cancer in 5 years preceding the screening visit other than non-melanoma skin cancer.
* Pregnant women.
* Women of child-bearing potential who are unwilling to avoid pregnancy or use an effective form of birth control.
* Currently on dialysis or planning to start dialysis.
* Is currently enrolled or participated in another device, drug, or biological trial within 30 days of screening.
* Has used wound treatments with enzymes, growth factors, living skin, dermal substitutes including other amniotic or umbilical cord tissue therapies, or other advanced biological therapies within the last 30 days.
* Current use of topical anti-microbial or silver-containing products.
* Target ulcer is over an active or inactive Charcot deformity.
* The depth of the target ulcer is graded as Wagner Grade III or higher, i.e., with evidence of exposed muscle, tendon, bone, and/or joint capsule.
* Gangrene is present on any part of the affected foot.
* Current suspicion of osteomyelitis, cellulitis, or other clinical signs or symptoms of target ulcer infection.
* Any previous use of Vendaje®, Vendaje AC®, AmnioWrap2® applied to the target ulcer.

The following additional exclusion criteria should be reviewed for all subjects at the end of the screening run-in period prior to randomization for eligibility determination:

* The target ulcer has decreased \> 30% in wound area post debridement at baseline following the two-week run-in period.
* Use of excluded concomitant medications, therapies, or procedures during the two-week run-in period.
* Has clinical signs or symptoms of infection within the target ulcer.

Where this trial is running

San Francisco, California and 10 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Diabetic Foot Ulcernon-infected diabetic foot ulcerdiabetic foot woundnon-ischemic diabetic foot ulcer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.