A Prospective Clinical Study to Evaluate the Effectiveness and Safety of Xcell Amnio MatrixTM (XAM) in the Management of Chronic Non-healing DFUs

NCT07116174 | Recruiting

• 1 other identifier: XAM-001
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this clinical trial is to evaluate the clinical outcomes of Diabetic Foot Ulcers (DFUs) treated with a weekly application of Xcell Amnio MatrixTM (XAM) as adjunct to standard of care (SOC) compared to SOC alone in male and female over the age of 18 years old. The main question it aims to answer is: What is the proportion of subjects with complete wound closure during the 12 weeks of the treatment phase? Participants:

• Will be screened and re-screened after 2 weeks to be assessed whether they meet the eligibility criteria
• Eligible subjects will receive study product application, and for 12 weeks will return to the clinic once every 7 days (±3 days) for treatment visits
• Subjects who complete the treatment will be followed up after 2 weeks

Conditions

Diabetic Foot Ulcer (DFU)

Keywords

DFU

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects with complete wound closure during the 12 weeks of the Treatment Phase

  Complete wound closure is defined as 100% re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart.

  Baseline to12 weeks

Secondary Outcomes (3)

• Wound Area Change (%) during the 12 weeks of the Treatment Phase

  Baseline to 12 weeks

• Time to complete wound closure during the 12 weeks of the Treatment Phase

  Baseline to 12 weeks

• Change in pain in the target ulcer assessed using the Numerical Pain Rating Scale (NPRS) during the 12 weeks of the Treatment Phase.

  Baseline to 12 weeks

Other Outcomes (6)

• Change in quality of life using the WOUND-Q (patient-reported outcome measure) assessment

  Baseline to 12 weeks

• Changes in tissue perfusion (tissue oxygen saturation (StO2), oxyhemoglobin, and deoxyhemoglobin) as measured by SnapshotNIR wound imaging device.

  Baseline to follow up visit at week 15

• Incidence and severity of treatment-emergent adverse events (TEAEs)

  Baseline to follow up visit at week 15

Study Arms (2)

Xcell Amnio MatrixTM (XAM) + Standard of Care (SOC)

EXPERIMENTAL

Biological: Xcell Amnio Matrix

Standard of Care (SOC)

ACTIVE COMPARATOR

Drug: Standard of Care (SOC)

Interventions

Xcell Amnio Matrix BIOLOGICAL

A lyophilized amniotic membrane allograft

Xcell Amnio MatrixTM (XAM) + Standard of Care (SOC)

Standard of Care (SOC) DRUG

The SOC will be based on investigator's choice

Standard of Care (SOC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will be eligible for enrollment in the study only if they meet ALL the following criteria at time of Screening:
• Subject is 18 years of age or older.
• Subject has diabetes mellitus (Type 1 or Type 2), requiring insulin or oral/injectable medications to control blood glucose levels
• Glycosylated hemoglobin (HbA1c) level is \<12%
• Note: Prior documented HbA1c within 12 weeks of Screening is acceptable.
• Duration of ulcer is ≥ 4 weeks but ≤ 1 year, unresponsive to SOC
• Ulcer area is ≥ 1.5cm2 and ≤ 20cm2 and with a clean, granulating base with minimal adherent slough at the Baseline Visit
• Ulcer location is at or below the ankle (malleolus)
• Subject is amenable to use of off-loading, as needed for plantar ulcer
• Ulcer extends through the full thickness of the skin but not down to muscle, tendon, or bone
• Subject is at least 12 weeks post lower extremity revascularization procedure, if one has been performed.
• Subject is in general good health, with no clinically significant medical conditions or abnormalities that, in the opinion of the Investigator, would interfere with study participation, the assessment of study endpoints, or pose additional risk to the subject.
• Adequate circulation to the affected lower extremities as demonstrated by one of the following within 12 weeks of screening:
• Dorsum transcutaneous oxygen measurement (TCOM) ≥ 30 mmHg,
• Skin perfusion pressure (SPP) measurement ≥ 30 mmHg,

You may not qualify if:

• Subjects meeting ANY of the following criteria at time of Screening will be excluded from enrollment:
• Clinical evidence of ongoing infection and/or receipt of IV, oral, or topical antimicrobials.
• Wheelchair bound or bed-ridden (ambulatory with assistance is acceptable).
• Ulceration at the site of amputation.
• Undergoing renal dialysis.
• Known or suspected malignancy in the target ulcer, or a history of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancer).
• Documented history of osteomyelitis at the target ulcer location within 6 months of screening.
• History of radiation at the ulcer site.
• New York Heart Association Class III or IV congestive heart failure or uncontrolled cardiac dysrhythmia.
• Diagnosis of autoimmune disease(s) (rheumatoid arthritis, lupus, psoriasis, Sjogren's syndrome) or arthritis requiring corticosteroid treatment.
• Subject has received in the past 4 weeks or is scheduled to receive any of following medication or therapies during the course of the study:
• Immunosuppressants (including chronic systemic corticosteroids or application of topical steroids to the ulcer surface)
• Cytotoxic chemotherapy
• Growth hormone
• Oral or systemic antifungal or antituberculosis treatment

Sponsors & Collaborators

• New Horizon Medical Solutions: lead
• Amarex Clinical Research: collaborator

Study Sites (3)

Limb Preservation Platform, Inc.

Fresno, California, 93710, United States

RECRUITING

North Park Podiatry

San Diego, California, 92104, United States

RECRUITING

Richard C. Galperin

Dallas, Texas, 75208, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Dawn Shepherd

CONTACT

817-233-1295; dawn.shepherd@nhmedical.com

Kher Lee Ng

CONTACT

KherLeeN@amarexcro.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 11, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: March 31, 2026

Record last verified: 2025-07

Locations

US (3)