Efficacy of Placental Membrane Dressings in Accelerating Diabetic Foot Healing
Recruiting now · Phase 4
Conditions studied: Diabete Mellitus, Foot Ulcer Chronic
In brief
Evaluation of Efficacy of Placental Membrane Dressings in Accelerating Diabetic Foot Healing
Key facts
- Study ID
- NCT07326553
- Run by
- BioXTek
- People needed
- 30
- Starts
- 2025-12-01
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-01-08
Who can join
Age: 45 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Hemoglobin A1c (HbA1c) level is > 10%.
- Chronic oral steroid use of > 7.5 mg daily within the previous 30 days preceding screening.
- Chronic oral or parenteral corticosteroids, or any cytotoxic agents within the previous 30 days preceding screening.
- Has tested positive for Human Immunodeficiency Virus (HIV) or has Acquired Immune Deficiency Syndrome (AIDS).
- Has malignancy or history of cancer in 5 years preceding the screening visit other than non- melanoma skin cancer.
- Pregnant or lactating women.
- Women of child-bearing potential who are unwilling to avoid pregnancy or use an effective form of birth control.
- Currently on dialysis or planning to start dialysis.
- Is currently enrolled or participated in another device, drug, or biological trial within 30 days of screening.
- 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.
- Current use of topical anti-microbial or silver-containing products.
- Target ulcer is over an active or inactive Charcot deformity.
- 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.
- Gangrene is present on any part of the affected foot.
- Current suspicion of osteomyelitis, cellulitis, or other clinical signs or symptoms of target ulcer infection.
- Any previous use of human placental membrane applied to the target ulcer.
Where it is running
- Axsendo — Phoenix, Arizona, United States (enrolling)
- Axsendo Clinical Research — Houston, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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