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
All sentinel cohort participants will receive biologic plus SOC. who receive at least one treatment of the biologic plus SOC and complete the treatment period of 12 weeks.Standard wound care for diabetic foot ulcersParticipants in the randomized phase are assigned by randomization (2:1) to BIOxHEAL plus SOC or SOC alone. once weekly for up to 12 weeks or until complete ulcer closure
All sentinel cohort participants will receive biologic plus SOC. who receive at least one treatment of the biologic plus SOC and complete the treatment period of 12 weeks.: BIOxHEAL is a sterile, single-use biologic derived from human amniotic membrane. It retains the native extracellular matrix structure and naturally occurring biologically active factors of the tissue. It is applied topically to the target ulcer once weekly, together with standard of care, for up to 12 weeks or until complete closure. At each visit, the investigator selects the presentation size that covers the entire ulcer surface without unnecessary excess. Each unit is individually packaged for single-patient, one-time use.
Standard wound care for diabetic foot ulcers: Standard wound care for diabetic foot ulcers: sharp debridement as clinically indicated; wound cleansing with normal saline; moist wound environment using protocol-specified dressings; offloading of plantar ulcers with a device approved by the Medical Monitor; optimization of glycemic control with the participant's providers; nutritional assessment and counseling; and smoking-cessation counseling for current smokers.
Participants in the randomized phase are assigned by randomization (2:1) to BIOxHEAL plus SOC or SOC alone. once weekly for up to 12 weeks or until complete ulcer closure: Standard wound care for diabetic foot ulcers: sharp debridement
Study summary
BIOxHEAL is an investigational biologic made from donated human amniotic membrane, placed directly on the wound to help it heal. Adults with type 1 or type 2 diabetes who have a foot ulcer that has not healed with standard wound care may be able to join. Participants are assigned by chance to one of two groups: BIOxHEAL plus standard wound care, or standard wound care alone. Both groups visit the clinic once a week for up to 12 weeks, or until the ulcer has fully closed. The main question is whether more ulcers close completely by Week 12 when BIOxHEAL is added to standard care
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Age 18 years or older
* Diagnosis of type 1 or type 2 diabetes mellitus
* At randomization, a target ulcer with a surface area of 1.0 cm² to 25.0 cm², measured after debridement
* Target ulcer present for at least 4 weeks and no more than 52 weeks of standard of care before the first screening visit
* Target ulcer located on the foot, with at least 50% of the ulcer below the malleolus
* Target ulcer is Wagner grade 1, extending at least through the dermis or subcutaneous tissue
* Adequate blood flow to the affected limb, confirmed within 3 months of the first screening visit by any one of the following:
* Ankle-brachial index (ABI) of 0.7 to 1.3
* Toe-brachial index (TBI) of 0.6 or higher \* Transcutaneous oxygen measurement (TcPO2) of 40 mmHg or higher
* Arterial Doppler ultrasound showing biphasic dorsalis pedis and posterior tibial flow at the ankle of the affected limb
* If two or more ulcers are present, they are at least 2 cm apart (the largest eligible ulcer is the target ulcer)
* Agrees to use the prescribed offloading method for the whole study
* Agrees to attend the weekly study visits
* Willing and able to take part in the informed consent process
Exclusion Criteria:
* Life expectancy of less than 6 months
* Target ulcer not caused by diabetes
* Infected target ulcer, or cellulitis of the surrounding skin
* Osteomyelitis of the target ulcer, based on clinical assessment supported by at least one of the following:
* Imaging consistent with osteomyelitis (e.g., X-ray, MRI or nuclear medicine study)
* Positive bone culture
* Abnormal inflammatory markers (e.g., ESR, CRP) with clinical signs highly suggestive of osteomyelitis, in the Investigator's judgment
* Infection of the target ulcer or elsewhere that requires systemic antibiotics
* Current use of immunosuppressants (including systemic corticosteroids above 10 mg prednisone per day or equivalent) or cytotoxic chemotherapy
* Topical steroids applied to the ulcer within 1 month before the first screening visit
* Previous partial amputation of the affected foot, if the resulting deformity prevents proper offloading of the target ulcer
* HbA1c of 12% or higher within 3 months before the first screening visit
* Target ulcer area decreased by more than 20% in the 2 weeks before the first screening visit
* Target ulcer area decreases by 25% or more during the screening period on standard of care (from the first screening visit to the randomization visit)
* Acute Charcot foot, or inactive Charcot foot that prevents proper offloading of the target ulcer
* Pregnant, or planning to become pregnant within the next 6 months
* Unwilling or unable to use the required contraception during the study
* End-stage renal disease requiring dialysis
* Any medical or psychological condition that, in the Investigator's opinion, may interfere with study assessments
* Hyperbaric oxygen therapy or a cellular and/or tissue-based product (CTP) within 30 days before the first screening visit
* Mini Nutritional Assessment (MNA) score below 17
Primary outcome measure(s)
Primary Endpoint - Proportion of Target Ulcers with Complete Closure at Week 12 — Baseline to Week 12 The percentage of target ulcers achieving wound healing in 12 weeks. Complete wound healing will be determined by the Investigator and confirmed by blinded, independent evaluators with expertise in wound care
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.
