Actively Recruiting
Efficacy of Placental Membrane Dressings in Accelerating Diabetic Foot Healing
Led by BioXTek · Updated on 2026-01-08
30
Participants Needed
2
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Evaluation of Efficacy of Placental Membrane Dressings in Accelerating Diabetic Foot Healing
CONDITIONS
Official 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, as of the date of the screening visit.
- Confirmed diagnosis of Type 1 or Type 2 diabetes mellitus.
- Has a diabetic foot ulcer located below the malleoli ranging in size from 1.0 cm2 to 20.0 cm2, post debridement.
- The diabetic foot ulcer has been present for at least 4 weeks and no more than 12 months.
- The ulcer is non-healing, defined as less than 30% reduction in size despite standard care between screening and study day 1.
- If more than one ulcer is present, the target ulcer must be at least 2 cm away from any other ulcers.
- The ulcer depth is Wagner Grade I or II with no exposed muscle, tendon, bone, or joint capsule.
- Adequate arterial blood supply to the foot confirmed by at least one specified measurement.
- Willing to follow all investigator instructions, attend all visits, and adhere to off-loading protocols during the study.
You will not qualify if you...
- Hemoglobin A1c level greater than 10%.
- Chronic oral steroid use over 7.5 mg daily within the 30 days before screening.
- Use of oral or parenteral corticosteroids or cytotoxic agents within 30 days before screening.
- Positive test for HIV or diagnosis of AIDS.
- History of malignancy or cancer within 5 years prior to screening, except non-melanoma skin cancer.
- Pregnant or lactating women.
- Women of child-bearing potential unwilling to avoid pregnancy or use effective birth control.
- Currently on dialysis or planning to start dialysis.
- Participation in another device, drug, or biological trial within 30 days before screening.
- Use of wound treatments such as enzymes, growth factors, skin substitutes, amniotic or umbilical cord tissue therapies within the last 30 days.
- Current use of topical antimicrobial or silver-containing products.
- Target ulcer located over an active or inactive Charcot deformity.
- Ulcer depth graded as Wagner Grade III or higher with exposed muscle, tendon, bone, or joint capsule.
- Presence of gangrene on any part of the affected foot.
- Suspected osteomyelitis, cellulitis, or infection signs in the target ulcer.
- Previous use of human placental membrane applied to the target ulcer.
AI-Screening
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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
CONTACT
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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