A Prospective Clinical Study to Evaluate the Effectiveness and Safety of Xcell Amnio MatrixTM (XA… (NCT07116174) | Clinical Trial Compass
RecruitingNot Applicable
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 range18 Years
SexALL
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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
✓. 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.
✕
What they're measuring
1
Proportion of subjects with complete wound closure during the 12 weeks of the Treatment Phase
. 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.