Actively Recruiting
Trial to Evaluate the Safety and Effectiveness of Treatment With COMS One Device in Subjects With Diabetic Foot Ulcers
Led by Piomic Medical · Updated on 2026-02-17
450
Participants Needed
30
Research Sites
208 weeks
Total Duration
On this page
Sponsors
P
Piomic Medical
Lead Sponsor
N
NAMSA
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Trial to Evaluate the Safety and Effectiveness of Treatment With COMS One Device in Subjects With Diabetic Foot Ulcers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 22 to 90 years
- Female participants of childbearing potential must use acceptable contraception throughout the study
- Ability to understand and sign informed consent and comply with study requirements
- Diagnosis of type 1 or type 2 diabetes mellitus
- Presence of one full-thickness diabetic foot ulcer at or below the ankle
- Ulcer classified as Wagner Grade 1 or 2 without bone exposure
- At least 2 cm distance between target ulcer and any other ulcer on the same foot after debridement
- Ulcer duration longer than 30 days and less than 52 weeks
- Ulcer size between 0.5 and 25 cm² at screening
- Adequate blood flow to the affected limb based on specified vascular measurements
You will not qualify if you...
- Known pregnancy or breastfeeding
- Active skin cancer, history of skin cancer, other localized cancer, precancerous lesions, or large moles in treatment area
- Use of medications that may interfere with ulcer healing as judged by investigator
- Current treatment for active systemic infection including bone infection
- Ulcer classified as Wagner Grade 3, 4, or 5
- Participation in another investigational drug or device trial within 30 days before or during this trial
- Any medical condition posing unreasonable risk as judged by investigator
- Chronic kidney failure requiring dialysis
- Use of systemic corticosteroids at specified doses and durations
- Ulcer showing significant healing during run-in phase (specific closure percentages)
- Abnormal blood chemistry or blood cell counts outside specified thresholds
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 30 locations
1
Titan Clinical Research
Mesa, Arizona, United States, 85202
Actively Recruiting
2
Southern Arizona VA Health Care System
Tucson, Arizona, United States, 85723
Actively Recruiting
3
Center for Clinical Research Inc.
Castro Valley, California, United States, 94546
Actively Recruiting
4
VA Central California Healthcare
Fresno, California, United States, 93703
Actively Recruiting
5
Limb Preservation Platform, Inc.
Fresno, California, United States, 93710
Actively Recruiting
6
Angel City Research, Inc.
Los Angeles, California, United States, 90010
Actively Recruiting
7
UCLA Ronald Regan - Department of Surgery
Los Angeles, California, United States, 90095
Actively Recruiting
8
Center for Clinical Research Inc.
San Francisco, California, United States, 94115
Actively Recruiting
9
Center for Clinical Research Inc.
San Francisco, California, United States, 94117
Actively Recruiting
10
ILD Research Center
Vista, California, United States, 92081
Actively Recruiting
11
Bay Pines VA Healthcare System
Bay Pines, Florida, United States, 33744
Actively Recruiting
12
MCR Health
Bradenton, Florida, United States, 34208
Actively Recruiting
13
University of Florida Health Jacksonville
Jacksonville, Florida, United States, 32209
Withdrawn
14
Clever Medical Research LLC
Miami, Florida, United States, 33126
Actively Recruiting
15
The Angel Medical Research Corporation
Miami Lakes, Florida, United States, 33016
Withdrawn
16
Vital Medical Research
Sweetwater, Florida, United States, 33174
Actively Recruiting
17
Aiyan Diabetes Center
Augusta, Georgia, United States, 30907
Actively Recruiting
18
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Actively Recruiting
19
Rush University
Chicago, Illinois, United States, 60612
Withdrawn
20
Gateway Clinical Trials
O'Fallon, Illinois, United States, 62269
Actively Recruiting
21
Curalta Clinical Trials
Westwood, New Jersey, United States, 07675
Actively Recruiting
22
Veteran Affairs of WNY Healthcare System
Buffalo, New York, United States, 14215
Actively Recruiting
23
Northwell Comprehensive Wound Healing Center
Lake Success, New York, United States, 11042
Withdrawn
24
UNC Medical Center
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
25
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
26
UPMC McKeesport
McKeesport, Pennsylvania, United States, 15132
Actively Recruiting
27
Vanderbilt University Medical Center - Vanderbilt Wound Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
28
Richard C. Galperin DPM PA
Dallas, Texas, United States, 75208
Actively Recruiting
29
HCA Healthcare Houston Medical Center
Houston, Texas, United States, 77004
Actively Recruiting
30
Futuro Clinical Trials, LLC
McAllen, Texas, United States, 78501
Actively Recruiting
Research Team
R
Rejelle Williams
CONTACT
B
Bernard Laurel
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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