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

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

Study Overview

• Status: Recruiting
• Conditions: Diabete Mellitus; Foot Ulcer Chronic
• Intervention / Treatment: Biological: Placental Membrane

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Josh Arnold; Phone Number: 302-604-4532; Email: Josh.Arnold@Purity-Health.com

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85024
      • Recruiting
      • Axsendo
      • Contact: Tasha Marriot; Phone Number: 602-730-9500; Email: tasha.marriott@axsendoclinical.com
      • Principal Investigator: Udupa, MD
  • Texas
    • Houston, Texas, United States, 77058
      • Recruiting
      • Axsendo Clinical Research
      • Contact: Kassiy Pierce; Phone Number: 281-377-3988; Email: kassidy.tommapierce@axsendoclinical.com
      • Principal Investigator: Lepow, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placental Membrane Dressing	Biological: Placental Membrane; Dehyrdated Placental Membrane
No Intervention: Historical Controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Closure	Proportion of subjects achieving ≥90% wound closure.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to wound closure	Time in number of days to ≥90% wound closure over the 12- week treatment period, starting from baseline to the time of initial observation of wound closure	12 weeks
Percent Change	Percent change from baseline in wound surface area (cm2)	12 weeks

Collaborators and Investigators

• Sponsor: BioXTek

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 6, 2026
• First Submitted That Met QC Criteria: January 7, 2026
• First Posted (Actual): January 8, 2026

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus; membrane-associated placental tissue protein 1
• Other Study ID Numbers: BX-PM-DW-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Plan Description De-identified individual participant data (IPD) collected during the study will be made available to qualified researchers. Shared IPD will include participant-level demographic and baseline characteristics, wound characteristics, treatment assignment, and outcome measures related to diabetic foot ulcer healing (e.g., wound closure status, time to closure, wound area measurements, and adverse event data), as well as relevant analyzable datasets. Data will be shared in a de-identified format and will not include direct identifiers.

Access Criteria Access to de-identified IPD will be provided upon reasonable request to the study sponsor/principal investigator after publication of the primary results. Requests must include a research proposal and statistical analysis plan and will be reviewed for scientific merit and compliance with applicable ethical and privacy requirements. Data will be shared under a data use agreement and may be accessed through a secure data-shar

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No