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
Public ClinicalTrials.gov record NCT07852338. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT07852338
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 253 participants
Conditions and interventions
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
- Standard wound care for diabetic foot ulcers Other
- 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
Biological · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 8, 2026 (Estimated)
- Primary completion
- Nov 2028 (Estimated)
- Completion
- Jan 2029 (Estimated)
- Last update posted
- Oct 1, 2026
2026 – 2029
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| NOMS Ankle and Foot Care Center | Boardman | Ohio | 44512 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07852338, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 1, 2026 · Synced Oct 2, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07852338 live on ClinicalTrials.gov.