Actively Recruiting
A Prospective, Multi-center, Randomized Controlled Trial Evaluating Xcell Amnio MatrixTM with Standard Care Compared to Standard Care Alone for Diabetic Foot Ulcers
Led by New Horizon Medical Solutions · Updated on 2026-03-31
135
Participants Needed
3
Research Sites
N/A
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
Researchers are evaluating the clinical outcomes of treating Diabetic Foot Ulcers (DFUs) with a weekly application of Xcell Amnio MatrixTM (XAM) alongside standard care, compared to standard care alone. The study aims to find out how many participants achieve complete wound closure during a 12-week treatment phase. Participants will be adults over 18 years old with chronic non-healing DFUs that meet specific criteria related to ulcer size, duration, and health status. The study involves two groups: one receiving Xcell Amnio MatrixTM plus standard care, and the other receiving only standard care chosen by the investigator. Eligible participants will receive weekly treatments with the study product for 12 weeks, returning to the clinic every 7 days (±3 days) for visits. After completing treatment, participants will have a follow-up visit two weeks later to assess continued healing. Participants will be screened and re-screened to confirm eligibility. Throughout the trial, researchers will monitor wound closure rates, changes in wound area, time to complete healing, and pain levels in the target ulcer using a pain rating scale. The total participation includes 12 weeks of treatment and a 2-week follow-up, with regular clinic visits to assess progress and ensure safety.
CONDITIONS
Brief 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
- Diagnosis of diabetes mellitus (Type 1 or Type 2) requiring insulin or medication to control blood glucose
- Glycosylated hemoglobin (HbA1c) level less than 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
- Ulcer located at or below the ankle (malleolus)
- Willingness to use off-loading devices if needed for plantar ulcers
- Ulcer extends through full skin thickness but not to muscle, tendon, or bone
- At least 12 weeks post lower extremity revascularization if applicable
- General good health without conditions interfering with study or adding risk
- Adequate circulation to affected lower limbs as shown by specified tests within 12 weeks
- Willing to use acceptable contraception during the trial if of childbearing potential
- Ability to understand and sign informed consent
- Availability and willingness to complete all study assessments and comply with standard care
You will not qualify if you...
- Evidence of ongoing infection or use of antimicrobials
- Wheelchair bound or bed-ridden status (ambulatory with assistance allowed)
- Ulcer at amputation site
- Undergoing renal dialysis
- Known or suspected cancer in target ulcer or recent cancer history (last 5 years)
- Osteomyelitis at ulcer site within 6 months
- History of radiation at ulcer site
- Severe heart failure or uncontrolled cardiac arrhythmia
- Autoimmune diseases requiring corticosteroid treatment
- Recent or planned use of immunosuppressants, chemotherapy, growth hormone, antifungals, or investigational drugs
- Prior treatment of ulcer with negative pressure, hyperbaric oxygen, or tissue-engineered materials within 4 weeks
- Anticipated need for negative pressure or hyperbaric oxygen therapy during study
- More than 35% ulcer healing during run-in period
- Pregnancy or breastfeeding
- Other conditions affecting ability to complete study or poor treatment adherence
- Active Charcot foot (stable chronic Charcot foot allowed)
- Ulcers only on toes 2, 3, 4, or 5 (ulcer on plantar surface of great toe allowed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive either Xcell Amnio Matrix along with standard care or standard care alone for diabetic foot ulcers.
Weekly visits for up to 12 weeks
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
K
Kher Lee Ng
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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