A Prospective Clinical Study to Evaluate the Effectiveness and Safety of Xcell Amnio MatrixTM (XA… (NCT07116174) | Clinical Trial Compass
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A Prospective Clinical Study to Evaluate the Effectiveness and Safety of Xcell Amnio MatrixTM (XAM) in the Management of Chronic Non-healing DFUs
United States135 participantsStarted 2025-08-15
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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%
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of subjects with complete wound closure during the 12 weeks of the Treatment Phase
. Ulcer extends through the full thickness of the skin but not down to muscle, tendon, or bone
Exclusion criteria
. 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.