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
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
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.
Parallel
Xcell Amnio Matrix
Biological/VaccineA lyophilized amniotic membrane allograft
Standard of Care (SOC)
DrugThe SOC will be based on investigator's choice
Proportion of subjects with complete wound closure during the 12 weeks of the Treatment Phase
Complete wound closure is defined as 100% re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart.
Wound Area Change (%) during the 12 weeks of the Treatment Phase
Wound area change is defined as the percentage of wound area change as measured by SnapshotNIR wound imaging device.
Time to complete wound closure during the 12 weeks of the Treatment Phase
The time of complete closure will be the visit when 100% re-epithelialization without drainage or dressing requirements was first achieved.
Change in pain in the target ulcer assessed using the Numerical Pain Rating Scale (NPRS) during the 12 weeks of the Treatment Phase.
Minimum value: 0 Maximum value: 100 Higher scores indicate a better outcome (greater satisfaction or improved quality of life related to wound care).
Change in quality of life using the WOUND-Q (patient-reported outcome measure) assessment
Exploratory Outcome Measure Minimum value: 0 Maximum value: 100 Higher scores indicate a better outcome (greater satisfaction or improved quality of life related to wound care).
Changes in tissue perfusion (tissue oxygen saturation (StO2), oxyhemoglobin, and deoxyhemoglobin) as measured by SnapshotNIR wound imaging device.
Exploratory Outcome Measure
Incidence and severity of treatment-emergent adverse events (TEAEs)
Safety Outcome Measure
Incidence of withdrawals due to Adverse Events (AEs)
Safety Outcome Measure
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New Horizon Medical Solutions
Lead sponsor
Amarex Clinical Research
Collaborator
