Placental membrane dressings to speed healing of diabetic foot ulcers

A Randomized, Open-Label Trial Evaluating the Efficacy of Placental Membrane Dressings in Accelerating Diabetic Foot Healing Compared to Matched Historical Controls Receiving Standard of Care

This trial will test whether placental membrane dressings help adults with diabetes and chronic foot ulcers heal faster.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 45 Years to 85 Years
• Sex: All
• Sponsor: BioXTek (Industry-sponsored)
• Locations: 2 sites (Phoenix, Arizona and 1 other locations)
• Trial ID: NCT07326553 on ClinicalTrials.gov

What this trial studies

This Phase 4 interventional study applies placental membrane dressings to eligible diabetic foot ulcers alongside standard wound care. Eligible ulcers are Wagner Grade I or II, located below the malleoli, measure 1.0–20.0 cm2 after debridement, and have been present 4 weeks to 12 months with <30% reduction on standard care; wound area is measured with an eKare device. Participants are treated and followed at outpatient sites in Phoenix or Houston to track wound-size change and time to closure. The trial tests real-world healing outcomes for a marketed placental membrane product.

Who should consider this trial

Good fit: Adults (≥18) with Type 1 or Type 2 diabetes who have a Wagner Grade I–II foot ulcer 1.0–20.0 cm2 located below the malleoli, present 4 weeks to 12 months, and showing <30% size reduction with standard care are ideal candidates.

Not a fit: Patients with deeper ulcers exposing muscle, tendon, bone, or joint capsule (Wagner Grade III+), inadequate arterial supply, active infection or osteomyelitis, ulcers outside the specified size/duration, or who cannot attend the study sites are unlikely to benefit.

Why it matters

Potential benefit: If successful, this approach could speed ulcer closure, reduce infections, and lower the risk of prolonged wound care or amputation.

How similar studies have performed: Previous clinical work with placental-derived (amnion/chorion) dressings has shown improved healing in many chronic wound and diabetic foot ulcer studies, so the approach has supportive evidence.

Eligibility criteria

Inclusion Criteria.

1. Patient has signed the informed consent form.
2. Male or female patient at least 18 years of age or older, as of the date of the screening visit.
3. Confirmed diagnosis of Type 1 or Type 2 DM.
4. Has a DFU that is located below the malleoli ranging in size from 1.0 cm2 to 20.0 cm2, post debridement, when measured by the investigator staff at the screening visit using the eKare device.
5. The DFU has been present for ≥4 weeks and ≤12 months.
6. The DFU is non-healing as defined as \<30% reduction in size in response to standard of care from Screening (Visit 1) to Study Day 1 (Visit 2).
7. If more than one ulcer is present the selected target ulcer must be at least 2 cm from the nearest edge of any adjacent ulcers.
8. The depth of the target foot ulcer is graded as Wagner Grade I or II, i.e., with no evidence of exposed muscle, tendon, bone, or joint capsule.
9. Arterial supply adequacy to the foot with the target ulcer confirmed by any one of the following and documented in medical record/EMR:

   1. Great toe pressure ≥ 40 mm/Hg
   2. Systolic blood pressure Ankle Brachial Index (ABI) in the range ≥ 0.70 ≤ 1.20
   3. TcPO2 ≥ 30 mmHg from the foot
   4. Toe Brachial Index or TBI ≥ 0.65
10. Willing to follow all instructions given by the Investigator, return for all visits, and adhere to off-loading protocols while on the study.

Exclusion Criteria

1. Hemoglobin A1c (HbA1c) level is \> 10%.
2. Chronic oral steroid use of \> 7.5 mg daily within the previous 30 days preceding screening.
3. Chronic oral or parenteral corticosteroids, or any cytotoxic agents within the previous 30 days preceding screening.
4. Has tested positive for Human Immunodeficiency Virus (HIV) or has Acquired Immune Deficiency Syndrome (AIDS).
5. Has malignancy or history of cancer in 5 years preceding the screening visit other than non- melanoma skin cancer.
6. Pregnant or lactating women.
7. Women of child-bearing potential who are unwilling to avoid pregnancy or use an effective form of birth control.
8. Currently on dialysis or planning to start dialysis.
9. Is currently enrolled or participated in another device, drug, or biological trial within 30 days of screening.
10. Has used wound treatments with enzymes, growth factors, living skin, dermal substitutes including other amniotic or umbilical cord tissue therapies, or other advanced biological therapies within the last 30 days.
11. Current use of topical anti-microbial or silver-containing products.
12. Target ulcer is over an active or inactive Charcot deformity.
13. The depth of the target ulcer is graded as Wagner Grade III or higher, i.e., with evidence of exposed muscle, tendon, bone, and/or joint capsule.
14. Gangrene is present on any part of the affected foot.
15. Current suspicion of osteomyelitis, cellulitis, or other clinical signs or symptoms of target ulcer infection.
16. Any previous use of human placental membrane applied to the target ulcer.

Where this trial is running

Phoenix, Arizona and 1 other locations

• Axsendo — Phoenix, Arizona, United States (Recruiting)
• Axsendo Clinical Research — Houston, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Josh Arnold

Conditions Diabete Mellitus; Foot Ulcer Chronic