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

Completed · Not applicable

Conditions studied: Diabetic Foot Ulcer

In brief

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.

Key facts

Study ID

NCT06511596

Run by

BioStem Technologies

People needed

71

Starts

2024-09-03

Expected to finish

2025-12-22

Last updated by the study team

2026-01-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Great toe pressure ≥ 40 mm/Hg
• Systolic blood pressure Ankle Brachial Index (ABI) in the range ≥ 0.70 ≤ 1.20
• TcPO2 ≥ 30 mmHg from the foot
• 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.

You may not qualify if…

• 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 it is running

• Site 02 — San Francisco, California, United States
• Site 04 — Sylmar, California, United States
• Site 07 — Torrance, California, United States
• Site 01 — Vista, California, United States
• Site 11 — Miami, Florida, United States
• Site 08 — North Chicago, Illinois, United States
• Site 06 — O'Fallon, Illinois, United States
• Site 10 — Westwood, New Jersey, United States
• Site 03 — Fort Worth, Texas, United States
• Site 09 — Frisco, Texas, United States
• Site 05 — McAllen, Texas, United States

Full record on ClinicalTrials.gov

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