Non-healing Diabetic Foot Ulcers Treated With Standard Care With or Without BR-AM

Launched by BIOSTEM TECHNOLOGIES · Aug 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how effective a new treatment called BR-AM is when used alongside standard care for patients with diabetic foot ulcers that are not healing. Diabetic foot ulcers are wounds that can develop on the feet of people with diabetes, and they can be difficult to treat. The trial is designed to compare the healing outcomes of patients receiving both BR-AM and standard care to those receiving only standard care. Participants will have regular visits to monitor their healing progress and to ensure they are following treatment guidelines properly.

To join this study, participants must be at least 18 years old and diagnosed with Type 1 or Type 2 diabetes. They should have a specific type of foot ulcer that has not healed for more than four weeks, and it should meet certain size and depth criteria. Throughout the trial, participants will receive careful monitoring and support, and if someone does not heal completely during the first 12 weeks of standard care, they will have the chance to receive the BR-AM treatment for an additional 12 weeks. This trial aims to provide more effective options for healing diabetic foot ulcers, which can greatly improve patients' quality of life.

Gender

ALL

Eligibility 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 eKare 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.