Xcell Amnio Matrix for Diabetic Foot Ulcers
This study is looking at how well a product called Xcell Amnio Matrix™ (XAM) works for people with chronic non-healing diabetic foot ulcers (DFUs). DFUs are open sores or wounds on the feet of people with diabetes. XAM is a special type of biological dressing made from amniotic membrane. The study will compare XAM, applied weekly along with standard care, to standard care alone. The main goal is to see how many people have their wounds completely close within 12 weeks. You may be able to join if you are 18 or older and have type 1 or type 2 diabetes requiring medication. The current recruitment status is unclear.
- Study design
- This is an interventional study planning to enroll 135 participants. It compares Xcell Amnio Matrix™ plus standard care to standard care alone.
- What's involved
- You will be screened and re-screened after 2 weeks. If eligible, you will receive weekly study product applications and return to the clinic every 7 days for 12 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- After completing the 12-week treatment, subjects will be followed up after 2 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Prospective Clinical Study to Evaluate the Effectiveness and Safety of Xcell Amnio MatrixTM (XAM) in the Management of Chronic Non-healing DFUs
At a glance
Conditions
Where it's being run
3 sites across 2 statesWho to contact
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What this trial measures
- Proportion of subjects with complete wound closure during the 12 weeks of the Treatment PhaseBaseline to12 weeks
Complete wound closure is defined as 100% re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart.