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Efficacy of Placental Membrane Dressings in Accelerating Diabetic Foot Healing | Clinical Trials | Clareo Health

RECRUITINGPHASE4

Efficacy of Placental Membrane Dressings in Accelerating Diabetic Foot Healing

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

NCT07326553•BioXTek

View on ClinicalTrials.gov

Summary

Evaluation of Efficacy of Placental Membrane Dressings in Accelerating Diabetic Foot Healing

Eligibility

Age

45 - 85 years

Sex

ALL

Healthy Volunteers

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
+4 more criteria

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.
+6 more criteria

Locations (2)

Axsendo

Phoenix, Arizona, United States

Axsendo Clinical Research

Houston, Texas, United States

Key Dates

Start Date

December 1, 2025

Primary Completion Date

July 31, 2026

Completion Date

December 31, 2026

Last Updated

January 8, 2026

Enrollment

ESTIMATED participants

Conditions

Diabete MellitusFoot Ulcer Chronic

Interventions

Placental Membrane

BIOLOGICAL

Contacts

Josh Arnold

CONTACT

302-604-4532 Josh.Arnold@Purity-Health.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 8, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy of Placental Membrane Dressings in Accelerating Diabetic Foot Healing

Inclusion Criteria

Exclusion Criteria

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