RECRUITING

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

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Conditions

Diabetic Foot UlcerRefractory Diabetic Foot Ulcer (DFU)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Concurrent Optical and Magnetic Stimulation (COMS) for Treatment of Refractory Diabetic Foot Ulcer; a Prospective Randomized, Sham-controlled, Double-blinded, Pivotal Clinical Trial

Quick Facts

Study Start:2023-06-19
Study Completion:2027-06-19
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05758545

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Subjects are male or female, ≥22 and ≤90 years of age
  2. 2. Female subjects of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence) starting at screening and throughout the duration of their study participation.
  3. 3. The participant (or LAR if applicable) must be able to understand and sign the informed consent form (ICF) and comply with requirements set in the protocol including trial visits, trial treatment and dressing regimens and compliance with required offloading device (if applicable)
  4. 4. Type 1 or Type 2 diabetes mellitus
  5. 5. Presence of one full-thickness DFU located at or below the malleoli (If the subject has more than one DFU that meets eligibility criteria, the investigator will designate one DFU as the target DFU to be treated in the trial)
  6. 6. Wagner Grade 1 or 2 (without bone exposure)
  7. 7. There is a minimum 2 cm margin between the target DFU and any other ulcer on that same foot, post-debridement
  8. 8. Target DFU duration \>30 days and \<52 weeks
  9. 9. Target DFU area between 0.5 - 25 cm2 at screening (Target DFU is ≥ 0.5cm2 after debridement at start of Run-In Phase)
  10. 10. Adequate vascular perfusion of the target limb (same limb as where the target DFU is located) as evidenced by: either a skin perfusion pressure (SPP) measurement of ≥30mmHg OR an ankle-brachial index (ABI) \>0.7 but less than 1.2 or a toe-brachial index (TBI) \>0.4 but less than 1.1 or a transcutaneous oxygen pressure (TcPO2) \>40mmHg
  1. 1. Known pregnancy or lactating
  2. 2. Active skin cancer, a history of skin cancer or any other localized cancer, precancerous lesions or large moles in the areas to be treated.
  3. 3. Subject who is taking any medications the Investigator believes may interfere with healing of the target DFU
  4. 4. Subject who is currently undergoing treatment for an active systemic infection, including osteomyelitis
  5. 5. Wagner Grade 3, 4 or 5
  6. 6. Participation in another trial with investigational drug or device within the 30 days preceding and during the present trial
  7. 7. Any co-morbid medical condition which places the subject at unreasonable risks in the opinion of the Investigator
  8. 8. Subject has chronic renal insufficiency requiring dialysis (end stage renal disease)
  9. 9. Subject is being treated with systemic corticosteroids (prednisone, dexamethasone, hydrocortisone, methylprednisolone, or similar) \>10mg/day for more than 10 days or any dose \>30 days
  10. 10. For subjects in the 2-Week Run-In Phase: more than 30% closure of target DFU at Screening Run-In Phase Visit I or Randomization/Baseline Visit or more than 50% closure of target DFU between the 2 Week Historical Period and Randomization/Baseline Visit (measured post-debridement)
  11. 11. For subjects in the 4-Week Run-In Phase: more than 30% closure of target DFU at Screening Run-In Visit II or between Screening Run-In Phase Visit II and Randomization/Baseline Visit or more than 50% closure of target DFU between Screening Run-In Phase Visit I and Randomization/Baseline Visit (measured post-debridement)
  12. 12. Blood chemistry or counts values as follows (based on subject's medical files):
  13. 1. Pre-albumin \<10 mg/dL OR albumin \<2.8 g/dL
  14. 2. Serum BUN \>60 mg/dL
  15. 3. Serum creatinine \>4.0 mg/dL
  16. 4. WBC \<2.0 x 109/L
  17. 5. Hemoglobin \<8.0 g/dL
  18. 6. Absolute neutrophil \<1.0 x 109/L
  19. 7. Platelet count \<50 x 109/L
  20. 8. HbA1C \>12%

Contacts and Locations

Study Contact

Rejelle Williams
CONTACT
+41 44 244 19 78
williams@piomic.com
Bernard Laurel
CONTACT
+1-855-574-6642
laurel@piomic.com

Principal Investigator

Aksone Nouvong, DPM
PRINCIPAL_INVESTIGATOR
University of California, Los Angeles

Study Locations (Sites)

Titan Clinical Research
Mesa, Arizona, 85202
United States
Center for Clinical Research Inc.
Castro Valley, California, 94546
United States
Limb Preservation Platform, Inc.
Fresno, California, 93710
United States
Angel City Research, Inc.
Los Angeles, California, 90010
United States
UCLA Ronald Regan - Department of Surgery
Los Angeles, California, 90095
United States
Center for Clinical Research Inc.
San Francisco, California, 94115
United States
Center for Clinical Research Inc.
San Francisco, California, 94117
United States
Bay Pines VA Healthcare System
Bay Pines, Florida, 33744
United States
University of Florida Health Jacksonville
Jacksonville, Florida, 32209
United States
The Angel Medical Research Corporation
Miami Lakes, Florida, 33016
United States
Clever Medical Research LLC
Miami, Florida, 33126
United States
Aiyan Diabetes Center
Augusta, Georgia, 30907
United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
United States
Rush University
Chicago, Illinois, 60612
United States
Veteran Affairs of WNY Healthcare System
Buffalo, New York, 14215
United States
Northwell Comprehensive Wound Healing Center
Lake Success, New York, 11042
United States
UNC Medical Center
Chapel Hill, North Carolina, 27514
United States
The Ohio State University
Columbus, Ohio, 43210
United States
UPMC McKeesport
McKeesport, Pennsylvania, 15132
United States
Vanderbilt University Medical Center - Vanderbilt Wound Center
Nashville, Tennessee, 37232
United States
Richard C. Galperin DPM PA
Dallas, Texas, 75208
United States
HCA Healthcare Houston Medical Center
Houston, Texas, 77004
United States

Collaborators and Investigators

Sponsor: Piomic Medical

  • Aksone Nouvong, DPM, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-19
Study Completion Date2027-06-19

Study Record Updates

Study Start Date2023-06-19
Study Completion Date2027-06-19

Terms related to this study

Keywords Provided by Researchers

  • Refractory Diabetic Foot Ulcer (DFU)

Additional Relevant MeSH Terms

  • Diabetic Foot Ulcer