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

Conditions

• Amniotic Membrane Placental Allograft
• Biologic
• Diabetic Foot Ulcer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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
  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 — OTHER
  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 — BIOLOGICAL
  Standard wound care for diabetic foot ulcers: sharp debridement

Study Details

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

Key Dates

First listed

Oct 1, 2026

Start date

Oct 8, 2026

Status verified

Sep 2026

Primary completion

Nov 30, 2028

Completion

Jan 31, 2029

Study Design

Enrollment

253 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Sentinel Cohort: BIOxHEAL + SOC
  All sentinel cohort participants will receive BIOxHEAL plus SOC. who receive at least one treatment of the biologic plus SOC and complete the treatment period of 12 weeks.
• Active Comparator: Randomized: SOC Alone
  To determine the efficacy of SOC alone in achieving wound healing of nonhealing diabetic foot ulcers over 12 weeks.
• Experimental: Randomized: BIOxHEAL + SOC
  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

Primary Outcome Measure

Primary Endpoint - Proportion of Target Ulcers with Complete Closure at Week 12 [ Time Frame: Baseline to Week 12 ]

Central Contacts

• susan A weins, RN
  2505142586
  [email protected]

Locations (1)

Find similar trials in Boardman, OH

Related Studies

• Trial to Evaluate the Safety and Effectiveness of Treatment With COMS One Device in Subjects With Diabetic Foot Ulcers
  Recruiting · Piomic Medical · Mesa, Arizona
• Kerecis Real-World Fish Skin Graft Registry
  Enrolling By Invitation · Kerecis Ltd. · Sarasota, Florida
• Modified Multi-Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of DFU and VLUs
  Recruiting · Stability Biologics · Circleville, Ohio
• A Study to Evaluate the Efficacy of a Purified Native Type 1 Collagen Extracellular Matrix With Polyhexamethylene Biguanide Antimicrobial (PCMP) and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers
  Recruiting · Organogenesis · Clevland, Ohio