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Tests treatment safety and results for Diabetic Foot Ulcer
Official title Trial to Evaluate the Safety and Effectiveness of Treatment With COMS One Device in Subjects With Diabetic Foot Ulcers
ClinicalTrials.gov ID: NCT05758545
What this study is testing
- What it's testing
- 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.
- Time commitment: about 4 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 90
You may be able to join if
- people are male or female, ≥22 and ≤90 years of age
- Female people of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence)...
- 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...
- Type 1 or Type 2 diabetes mellitus
- 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...
You likely can't join if
- Known pregnancy or lactating
- Active skin cancer, a history of skin cancer or any other localized cancer, precancerous lesions or large moles in the areas to be treated.
- Subject who is taking any medications the Investigator believes may interfere with healing of the target DFU
- Subject who is currently undergoing treatment for an active systemic infection, including osteomyelitis
- Wagner Grade 3, 4 or 5
- Participation in another trial with investigational drug or device within the 30 days preceding and during the present trial
See the full eligibility criteria
- people are male or female, ≥22 and ≤90 years of age
- Female people 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...
- 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...
- Type 1 or Type 2 diabetes mellitus
- 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...
- Wagner Grade 1 or 2 (without bone exposure)
- There is a minimum 2 cm margin between the target DFU and any other ulcer on that same foot, post-debridement
- Target DFU duration \>30 days and \<52 weeks
- Target DFU area between 0.5 - 25 cm2 at screening (Target DFU is ≥ 0.5cm2 after debridement at start of Run-In Phase)
- 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...
- Known pregnancy or lactating
- Active skin cancer, a history of skin cancer or any other localized cancer, precancerous lesions or large moles in the areas to be treated.
- Subject who is taking any medications the Investigator believes may interfere with healing of the target DFU
- Subject who is currently undergoing treatment for an active systemic infection, including osteomyelitis
- Wagner Grade 3, 4 or 5
- Participation in another trial with investigational drug or device within the 30 days preceding and during the present trial
- Any co-morbid medical condition which places the subject at unreasonable risks in the opinion of the Investigator
- Subject has chronic renal insufficiency requiring dialysis (end stage renal disease)
- 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
- For people 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...
- For people 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...
- Blood chemistry or counts values as follows (based on subject's medical files):
- Pre-albumin \<10 mg/dL OR albumin \<2.8 g/dL
- Serum BUN \>60 mg/dL
- Serum creatinine \>4.0 mg/dL
- WBC \<2.0 x 109/L
- Hemoglobin \<8.0 g/dL
- Absolute neutrophil \<1.0 x 109/L
- Platelet count \<50 x 109/L
- HbA1C \>12%
The study team makes the final eligibility decision.
Where it's taking place
- Mesa, Arizona, United States
- Tucson, Arizona, United States
- Castro Valley, California, United States
- Fresno, California, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- Vista, California, United States
- Bay Pines, Florida, United States
- Bradenton, Florida, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- Sweetwater, Florida, United States
- Augusta, Georgia, United States
- Chicago, Illinois, United States
- O'Fallon, Illinois, United States
- Westwood, New Jersey, United States
- Buffalo, New York, United States
- Lake Success, New York, United States
- Chapel Hill, North Carolina, United States
+ 6 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mesa, Arizona, United States; Tucson, Arizona, United States; Castro Valley, California, United States; Fresno, California, United States; Los Angeles, California, United States; San Francisco, California, United States and 20 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.