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NCT05758545 · ClinicalTrials.gov registry record · NA
Trial to Evaluate the Safety and Effectiveness of Treatment With COMS One Device in Subjects With Diabetic Foot Ulcers
A NA study of Diabetic Foot Ulcer, sponsored by Piomic Medical.
- Recruiting
- Registry status
- NA
- Development phase
- 450
- Enrollment target
- 20
- Study locations
NCT05758545: Recruiting NA study of Diabetic Foot Ulcer, sponsored by Piomic Medical.
NCT05758545 is a NA study of Diabetic Foot Ulcer that is actively recruiting participants, run by Piomic Medical. The registered enrollment target is 450 participants, above the 248-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (81% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05758545, a NA study of Diabetic Foot Ulcer, is actively recruiting participants, sponsored by Piomic Medical.
- RECRUITING
- Registry status
- NA
- Development phase
- 450 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
The primary endpoint for this pivotal trial is time to complete wound closure from randomization through 24 weeks, which is defined as complete skin re-epithelialization without drainage confirmed by 2 consecutive trial visits 2 weeks apart.
Conditions Studied
Interventions
- DEVICE Sham device
- DEVICE COMS One device
Study Locations (20)
California
- Center for Clinical Research Inc. - Castro Valley
- VA Central California Healthcare - Fresno
- Limb Preservation Platform, Inc. - Fresno
- Angel City Research, Inc. - Los Angeles
- UCLA Ronald Regan - Department of Surgery - Los Angeles
- Center for Clinical Research Inc. - San Francisco
- Center for Clinical Research Inc. - San Francisco
- ILD Research Center - Vista
Florida
- Bay Pines VA Healthcare System - Bay Pines
- MCR Health - Bradenton
- University of Florida Health Jacksonville - Jacksonville
- Clever Medical Research LLC - Miami
- The Angel Medical Research Corporation - Miami Lakes
- Vital Medical Research - Sweetwater
Illinois
- Northwestern University Feinberg School of Medicine - Chicago
- Rush University - Chicago
- Gateway Clinical Trials - O'Fallon
Arizona
- Titan Clinical Research - Mesa
- Southern Arizona VA Health Care System - Tucson
Georgia
- Aiyan Diabetes Center - Augusta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2023-06-19 |
| Est. Completion | 2027-06-19 |
| Phase | NA |
What NCT05758545 shows while recruiting
NCT05758545 is an interventional study that assigns participants to a tested intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap, above the 248-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (81% higher).
The record links to 1 condition, with Diabetic Foot Ulcer appearing as the primary indexed condition, and to 2 interventions - of which Sham device is the first listed.
NCT05758545 names 20 study sites across 5 states, led by California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT05758545 about?
NCT05758545 is a clinical study titled "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 ...
What is the current status of trial NCT05758545?
This trial is currently recruiting. It is a NA study. The enrollment target is 450 participants. The study started on 2023-06-19. Estimated completion is 2027-06-19.
What conditions does trial NCT05758545 study?
This clinical trial studies the following conditions: Diabetic Foot Ulcer.
What interventions are being tested in trial NCT05758545?
The interventions under investigation include: Sham device (DEVICE), COMS One device (DEVICE).
Who is sponsoring clinical trial NCT05758545?
This trial is sponsored by Piomic Medical, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05758545 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetic Foot Ulcer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05758545's enrollment target sits among peer trials
450 5th of 67 higher than 63 of 67 other Diabetic Foot Ulcer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Foot Ulcer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Feasibility and Effectiveness of a Remote Monitoring Program for the Treatment of Diabetic Foot Ulcers
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-
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Modified Platform Trial Evaluating PpLHACM and SOC Versus SOC Alone in the Treatment of Nonhealing DFUs
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-
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