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
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
Life expectancy of less than 6 months
Target ulcer not caused by diabetes
Infected target ulcer, or cellulitis of the surrounding skin
Imaging consistent with osteomyelitis (e.g., X-ray, MRI or nuclear medicine study)
Sequential
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.
Biological/VaccineBIOxHEAL 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
Other interventionStandard 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
Biological/VaccineStandard wound care for diabetic foot ulcers: sharp debridement
Primary Endpoint - Proportion of Target Ulcers with Complete Closure at 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
Proportion of Participants With Complete Closure of the Target Ulcer at Week 8
Complete closure is defined as 100% re-epithelialization of the target ulcer without drainage. It is assessed by the Investigator and confirmed by blinded independent evaluators using eKare digital imaging. The result is compared between biologic + SOC and SOC alone.
Mean Percent Change in Target Ulcer Surface Area From Baseline to Week 12
Target ulcer surface area is measured by eKare digital planimetry. Percent change = (Week 12 area - Baseline area) / Baseline area × 100. The result is compared between biologic + SOC and SOC alone.
Mean Change in Wound-QoL-17 Global Score From Baseline to Week 12
Wound-QoL-17 is a 17-item patient-reported questionnaire with a 7-day recall. Each item is scored from 0 ("not at all") to 4 ("very much"). The global score is the mean of the item scores and ranges from 0 to 4. Higher scores mean greater impairment of wound-related quality of life, which is a worse outcome. The result is compared between biologic + SOC and SOC alone.
Participants With Major or Minor Lower Extremity Amputation
This counts participants with at least one lower extremity amputation during the study, reported separately for major amputations (above the ankle) and minor amputations (at or below the ankle). It is summarized descriptively by treatment group.
Click on the lead sponsor to view all of their trials.
