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

Part of paid clinical trials in Fresno, California.

Sponsor
New Horizon Medical Solutions
Study ID
NCT07116174
Status
Recruiting
Apply to this trial

Conditions

  • Diabetic Foot Ulcer (DFU)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Xcell Amnio Matrix — BIOLOGICAL
    A lyophilized amniotic membrane allograft
  • Standard of Care (SOC) — DRUG
    The SOC will be based on investigator's choice

Study Details

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

Key Dates

Start date
Aug 15, 2025
Status verified
Jul 2025
Primary completion
Aug 15, 2026
Completion
Aug 15, 2026

Study Design

Enrollment
135 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Xcell Amnio MatrixTM (XAM) + Standard of Care (SOC)
  • Active Comparator: Standard of Care (SOC)

Primary Outcome Measure

Proportion of subjects with complete wound closure during the 12 weeks of the Treatment Phase [ Time Frame: Baseline to12 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Limb Preservation Platform, Inc.FresnoCalifornia93710
Shawn Cazzell, DPM
[email protected]
559-431-1700
Shawn Cazzell, DPM (PRINCIPAL_INVESTIGATOR)
North Park PodiatrySan DiegoCalifornia92104
Trent Brookshier, DPM
[email protected]
619-283-2097
Trent Brookshier, DPM (PRINCIPAL_INVESTIGATOR)
Richard C. GalperinDallasTexas75208
Richard Galperin, DPM, PA
[email protected]
214-330-9299
Richard Galperin, DPM, PA (PRINCIPAL_INVESTIGATOR)

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