This study is about testing a new device called **COMS One** to help heal **diabetic foot ulcers (DFUs)**, which are wounds on the feet that are hard to heal due to diabetes. The study will last **24 weeks** and will compare the COMS One device to a "sham" device, which is like a pretend device that does nothing, to see which works better. People in the study will receive normal care for their DFUs, along with either the real or sham device.
The main goal is to see how fast the ulcers heal completely. Ulcers are considered healed when the skin grows back fully and there is no drainage for two visits, two weeks apart. The study will also look at how safe the device is and how well it works.
- The study will include 450 people, but only 224 will be chosen to test the devices.
- Participants can be men or women, aged 22-90, with certain diabetes types and foot ulcers.
- The study involves regular visits to check on the ulcers and might require you to use special foot gear.
How understandable was the trial content above?
Hard to understand
Easy to understand