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Study identifier: NCT05758545 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Trial to Evaluate the Safety and Effectiveness of Treatment With COMS One Device in Subjects With Diabetic Foot Ulcers

Condition: Diabetic Foot Ulcer  ·  Sponsor: Piomic Medical

PhaseNA
Planned participants450
Who can joinAll sexes, 22 Years to 90 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Rejelle Williams  ·  +41 44 244 19 78  ·  williams@piomic.com

Bernard Laurel  ·  +1-855-574-6642  ·  laurel@piomic.com

Always discuss trial participation with your own doctor first.

Locations (30)

Titan Clinical ResearchMesa, Arizona, United StatesRecruiting
Southern Arizona VA Health Care SystemTucson, Arizona, United StatesRecruiting
Center for Clinical Research Inc.Castro Valley, California, United StatesRecruiting
VA Central California HealthcareFresno, California, United StatesRecruiting
Limb Preservation Platform, Inc.Fresno, California, United StatesRecruiting
Angel City Research, Inc.Los Angeles, California, United StatesRecruiting
UCLA Ronald Regan - Department of SurgeryLos Angeles, California, United StatesRecruiting
Center for Clinical Research Inc.San Francisco, California, United StatesRecruiting
Center for Clinical Research Inc.San Francisco, California, United StatesRecruiting
ILD Research CenterVista, California, United StatesRecruiting
Bay Pines VA Healthcare SystemBay Pines, Florida, United StatesRecruiting
MCR HealthBradenton, Florida, United StatesRecruiting

+ 18 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05758545