Actively Recruiting
A Prospective Clinical Study to Evaluate the Effectiveness and Safety of Xcell Amnio MatrixTM (XAM) in the Management of Chronic Non-healing DFUs
Led by New Horizon Medical Solutions · Updated on 2026-03-31
135
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
Sponsors
N
New Horizon Medical Solutions
Lead Sponsor
A
Amarex Clinical Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Prospective Clinical Study to Evaluate the Effectiveness and Safety of Xcell Amnio MatrixTM (XAM) in the Management of Chronic Non-healing DFUs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Diagnosed with Type 1 or Type 2 diabetes requiring insulin or medication to control blood glucose
- Glycosylated hemoglobin (HbA1c) level below 12% within 12 weeks of screening
- Ulcer duration between 4 weeks and 1 year unresponsive to standard care
- Ulcer size between 1.5 cm² and 20 cm² with a clean, granulating base and minimal slough
- Ulcer located at or below the ankle (malleolus)
- Willingness to use off-loading for plantar ulcers if needed
- Ulcer extends through full skin thickness but not into muscle, tendon, or bone
- At least 12 weeks since any lower extremity revascularization procedure
- Generally in good health without conditions that interfere with study participation
- Adequate circulation to affected lower extremity confirmed by specified tests within 12 weeks
- Willingness to use acceptable contraception if of childbearing potential
- Ability to read, understand, and sign informed consent
- Willing and able to comply with all study assessments and standard care procedures
You will not qualify if you...
- Ongoing infection or recent use of intravenous, oral, or topical antimicrobials
- Wheelchair-bound or bedridden status (ambulatory with assistance allowed)
- Ulceration at amputation sites
- Undergoing renal dialysis
- Known or suspected cancer in the target ulcer or cancer history within 5 years except certain skin cancers
- Osteomyelitis at target ulcer within 6 months
- History of radiation at the ulcer site
- Severe heart failure (NYHA Class III or IV) or uncontrolled heart rhythm problems
- Autoimmune diseases requiring corticosteroid treatment
- Recent or planned use of immunosuppressants, chemotherapy, growth hormone, antifungals, antituberculosis treatment, or investigational drugs/devices
- Prior treatment of target ulcer with certain advanced therapies within 4 weeks
- Anticipated need for negative pressure wound therapy or hyperbaric oxygen during the study
- More than 35% healing of the target ulcer during the run-in period
- Pregnancy or breastfeeding
- Conditions compromising ability to complete study or poor adherence history
- Active Charcot foot (stable chronic Charcot foot allowed)
- Ulcers limited to toes 2, 3, 4, or 5 only
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Limb Preservation Platform, Inc.
Fresno, California, United States, 93710
Actively Recruiting
2
North Park Podiatry
San Diego, California, United States, 92104
Actively Recruiting
3
Richard C. Galperin
Dallas, Texas, United States, 75208
Actively Recruiting
Research Team
D
Dawn Shepherd
CONTACT
K
Kher Lee Ng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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