Actively Recruiting
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
Led by BioXTek · Updated on 2026-01-08
30
Participants Needed
2
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of placental membrane dressings in speeding up the healing of diabetic foot ulcers. This randomized, open-label Phase 4 trial compares the healing process of patients treated with dehydrated placental membrane dressings to matched historical controls who received standard care. The study focuses on adults with diabetic foot ulcers that have not improved sufficiently with standard treatment. Participants in the study will receive the placental membrane dressing applied to their diabetic foot ulcer. The trial compares this treatment to historical control patients who received no intervention beyond standard care. The study includes a treatment period of 12 weeks during which wound closure and healing progress will be monitored. During the study, participants will have their wounds assessed regularly to measure wound closure, time to wound closure, and percent change in wound size over 12 weeks. Researchers will track these outcomes to evaluate the treatment's impact. Participants must follow study instructions, attend all visits, and adhere to off-loading protocols to support healing. The total participation time matches the 12-week observation period.
CONDITIONS
Brief Title
Efficacy of Placental Membrane Dressings in Accelerating Diabetic Foot Healing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has signed the informed consent form.
- Male or female patient at least 18 years of age or older.
- Confirmed diagnosis of Type 1 or Type 2 diabetes mellitus.
- Has a diabetic foot ulcer located below the ankle between 1.0 cm2 and 20.0 cm2 in size after debridement.
- Ulcer has been present for at least 4 weeks and up to 12 months.
- Ulcer is non-healing with less than 30% reduction in size despite standard care.
- If more than one ulcer is present, the target ulcer is at least 2 cm away from others.
- Ulcer depth is Wagner Grade I or II without exposed muscle, tendon, bone, or joint capsule.
- Adequate blood supply to the foot as confirmed by specific pressure or index measurements.
- Willing to follow study instructions, attend all visits, and adhere to off-loading protocols.
You will not qualify if you...
- Hemoglobin A1c level greater than 10%.
- Chronic oral steroid use above 7.5 mg daily within 30 days before screening.
- Use of corticosteroids or cytotoxic agents within 30 days before screening.
- Positive test for HIV or diagnosis of AIDS.
- Active malignancy or history of cancer within 5 years except non-melanoma skin cancer.
- Pregnant or breastfeeding women.
- Women of childbearing potential unwilling to use effective birth control.
- Currently on dialysis or planning to start dialysis.
- Participation in another drug, device, or biological trial within 30 days.
- Use of advanced wound treatments including enzymes, growth factors, or biological therapies within 30 days.
- Current use of topical antimicrobial or silver-containing products.
- Ulcer over a Charcot deformity.
- Ulcer depth Wagner Grade III or higher with exposed muscle, tendon, bone, or joint capsule.
- Presence of gangrene on affected foot.
- Suspected infection like osteomyelitis or cellulitis in the target ulcer.
- Previous use of human placental membrane on the target ulcer.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants receive placental membrane dressings to promote healing of their diabetic foot ulcers.
Weekly visits for up to 12 weeks
Trial Site Locations
Total: 2 locations
1
Axsendo
Phoenix, Arizona, United States, 85024
Actively Recruiting
2
Axsendo Clinical Research
Houston, Texas, United States, 77058
Actively Recruiting
Research Team
J
Josh Arnold
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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