This study is for people with non-healing venous leg ulcers (open sores on the leg caused by poor blood flow). It compares standard care for these ulcers with standard care plus a product called BR-AC. BR-AC is made from a human placental membrane. Researchers want to see if adding BR-AC helps wounds heal completely within 12 weeks better than standard care alone. You could be eligible if you are at least 18 years old and have a venous leg ulcer between 2 and 20 square centimeters that hasn't healed for at least 4 weeks. The study aims to enroll 60 participants. If you are in the standard care group and your wound doesn't heal in 12 weeks, you may be able to switch to receive BR-AC for another 12 weeks.

Study design

This is a multi-center, randomized, controlled study with 60 planned participants. It compares two groups: one receiving standard care and another receiving standard care plus BR-AC.

What's involved

Participants will have their wounds treated weekly for 12 weeks. There is a two-week run-in period before the main treatment begins.

Compensation

Not stated in the trial record.

Follow-up

The primary outcome of complete wound closure is measured over a 12-week treatment period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.