Study of Amnion-Intermediate-Chorion (AIC) for Diabetic Foot Ulcers
This study is looking at how well a treatment called Amnion-Intermediate-Chorion (AIC) helps heal diabetic foot ulcers when used with standard care, compared to standard care alone. AIC is a special dressing made from donated human placental tissue. Standard care involves cleaning the wound, removing dead tissue, taking pressure off the wound, and keeping it moist. You might be able to join if you are 18 or older, have type 1 or 2 diabetes with a controlled blood sugar level (HbA1c under 12%), and have a diabetic foot ulcer between 0.7 and 20 square centimeters. The main goal is to see what percentage of ulcers completely close within 1 to 12 weeks. The current status of this study is unclear, and it plans to enroll 120 participants.
- Study design
- This is an interventional study comparing two treatment approaches for diabetic foot ulcers, planning to enroll 120 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint, complete wound closure, is measured between 1 and 12 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.
Nonhealing Diabetic Foot Ulcers Treated With Standard of Care (SOC) Alone or Standard of Care and Amnion-Intermediate-Chorion (AIC)
At a glance
Conditions
Where it's being run
8 sites across 6 statesStudy leadership
- Research Director · STUDY_DIRECTOR · Cellution Biologics
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Percentage of ulcers with complete wound closure1-12 weeks
The percentage of DFU target ulcers achieving complete wound closure. Closure is defined as 100% re-epithelialization of the ulcer surface without detectable exudate.