Study details
Enrolling now
A Prospective Clinical Trial to Evaluate Xcell Amnio MatrixTM (XAM) in Managing Chronic Non-healing DFUs
New Horizon Medical Solutions
NCT IDNCT07116174ClinicalTrials.gov data as of Apr 2026
Target enrollment
108
Study length
about 1 year
Ages
18+
Locations
3 sites in CA, TX
What this study is about
This trial is testing whether applying Xcell Amnio MatrixTM (XAM) as an adjunct to standard care helps heal chronic non-healing diabetic foot ulcers. Participants will receive XAM weekly for 12 weeks and be followed up after treatment.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Receive Xcell Amnio Matrix
- 2.Take Standard of Care (SOC)
Participation Burden
What's physically and logistically required of participants.
Logistics & Travel
In-person visits
Requires travel to a study site
Physical Intervention
Standard
How treatment is administered
Treatment Assignment
Randomized (Open Label)
You are randomly assigned, but you will know your treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
Endpoints
Secondary: Change in pain in the target ulcer assessed using the Numerical Pain Rating Scale (NPRS) during the 12 weeks of the Treatment Phase.