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RECRUITING

NCT07852338

PHASE3

a Prospective, Multicenter, Randomized Controlled Trial, With a Non-randomized Sentinel Cohort, Evaluating the Efficacy of Bioxheal, a Single-layer Placental-derived Biologic in Nonhealing Diabetic Foot Ulcers

Sponsor: Applied Biologics, LLC

View on ClinicalTrials.gov

Summary

BIOxHEAL is an investigational placental-derived biologic being evaluated for the treatment of nonhealing diabetic foot ulcers. Adults with type 1 or type 2 diabetes who have a diabetic foot ulcer that has not healed with standard wound care may be eligible to participate. Participants in the randomized phase are assigned by chance in a 2:1 ratio to receive either BIOxHEAL administered topically in combination with standard of care (SOC), or SOC alone. Treatment is administered once weekly for up to 12 weeks or until complete ulcer closure. The primary objective is to evaluate whether BIOxHEAL plus SOC increases the proportion of target ulcers achieving complete closure at Week 12 compared with SOC alone.

Official title: a Randomized Controlled Multicenter Clinical Trial, Evaluating the Efficacy of a Single Layer Placental-based Biologic and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

253

Start Date

2026-10-08

Completion Date

2027-09

Last Updated

2026-10-16

Healthy Volunteers

Conditions

Diabetic Foot Ulcer Amniotic Membrane Placental Allograft Biologic

Interventions

OTHER

Standard of Care

Protocol-defined standard of care (SOC) for diabetic foot ulcers, performed at each study visit: wound cleansing with sterile saline, sharp debridement as clinically indicated, a non-adherent silicone primary dressing with an absorbent secondary dressing to maintain a moist wound environment, offloading for plantar and pressure-bearing ulcers (Foot Defender boot, Total Contact Cast, or Medical Monitor-approved equivalent), and diabetes education and nutritional support, including smoking cessation counseling for current smokers.

BIOLOGICAL

BIOxHEAL (human amniotic membrane allograft)

BIOxHEAL is an investigational, sterile, single-use biologic derived from human amniotic membrane. BIOxHEAL is administered topically to the target ulcer once weekly in combination with protocol-defined standard of care for up to 12 weeks or until complete ulcer closure. Each unit is individually packaged for single-patient, one-time use.

Inclusion Criteria: Participants must be at least 18 years of age or older. Participants must have a diagnosis of type 1 or 2 diabetes mellitus. At randomization (or enrollment for the sentinel cohort), participants must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 25.0 cm2 measured post debridement. The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit. The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus. The target ulcer must be Wagner Grade 1 extending at least through the dermis or subcutaneous tissue. The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable: ABI greater than or equal to 0.7 and less than or equal to 1.3 TBI greater than or equal to 0.6 TCOM greater than or equal to 40 mmHg Arterial Doppler ultrasound with biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle on the extremity where the index ulcer is located If the participant has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer. The participant must consent to using the prescribed offloading method for the duration of the study. The participant must agree to attend the weekly study visits required by the protocol. The participant must be willing and able to participate in the informed consent process. The participant must have a suitable living environment to manage prescribed offloading and wound care management. Exclusion Criteria: Known life expectancy of less than 6 months. Target ulcer is not secondary to diabetes. Wagner Grade 2 to 5 ulcers. Target ulcer is infected, or there is cellulitis in the surrounding skin. Evidence of osteomyelitis complicating the target ulcer, based on clinical assessment supported by at least one of the following: Imaging (for example, plain radiography, MRI, or nuclear medicine study) consistent with osteomyelitis Positive bone culture Abnormal inflammatory markers (for example, ESR, CRP) in conjunction with clinical signs highly suggestive of osteomyelitis per Investigator judgment - Documentation of the basis for diagnosing or excluding osteomyelitis must be available in the participant's source documents Infection in the target ulcer or in a remote location that requires systemic antibiotic therapy. Receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy. Topical application of steroids to the ulcer surface within one month of initial screening. Previous partial amputation on the affected foot, if the resulting deformity impedes proper offloading of the target ulcer. Glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit. The surface area of the target ulcer has reduced in size by more than 40% between Screening Visit 1 and Treatment Visit 1 during the protocol-defined screening period. Acute Charcot foot, or an inactive Charcot foot, that impedes proper offloading of the target ulcer. Women who are pregnant or considering becoming pregnant within the next 6 months. Male or female participants who are unwilling or unable to comply with the required contraceptive measures for the duration of study participation. End stage renal disease requiring dialysis. Serum creatinine level greater than 3.0 mg/dL. Aspartate aminotransferase (AST, GOT) and/or alanine aminotransferase (ALT, GPT) greater than 3 times the upper limit of normal. A medical or psychological condition that, in the opinion of the investigator, may interfere with study assessments. Treated with hyperbaric oxygen therapy or a Cellular and/or Tissue Product (CTP) in the 30 days prior to the initial screening visit. Mini Nutritional Assessment (MNA) screening score below 12.

Locations (1)

NOMS Ankle and Foot Care Center

Boardman, Ohio, United States