Status: Recruiting
Trial to Evaluate the Safety and Effectiveness of Treatment With COMS One Device in Subjects With Diabetic Foot Ulcers
The purpose of this clinical trial is to evaluate the safety and effectiveness of the treatment with the COMS One device in subjects with refractory diabetic foot ulcers (DFUs). The prospective randomized, double-blinded, sham-controlled trial is designed to demonstrate superiority of wound closure of the COMS One device to a sham-control device through 24 weeks post-application, when each is administered in conjunction with standard of care (SOC) in the treatment of DFUs.
Participants needed: 450
Trial details
Age: 22-90Biological sex: AllType: InterventionalSponsor: Piomic MedicalUpdated: Feb 17, 2026Locations: 30
Eligibility criteria
Subjects are male or female, ≥22 and ≤90 years of age [+9]
Known pregnancy or lactating [+18]