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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.
Full 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.
Primary Objective The COMS One Therapy System is intended to promote wound healing in chronic DFUs. As part of the clinical investigation, the primary objective is to determine time to complete wound healing, defined as complete skin re-epithelialization without drainage confirmed by 2 consecutive trial visits 2 weeks apart.
Secondary Objectives Secondary objectives are confirmation of safety and assessment of wound healing parameters as well as subject and site reported outcomes.
A total of 450 subjects with refractory DFU will be screened. It is expected that 50% of subjects will be excluded from the trial if either of the following occur between screening and randomization: >30% wound closure over a period of 2 weeks or >50% wound closure over a period of 4 weeks (measured post-debridement). The remaining 224 subjects will be randomized into two groups (112 Subjects Sham device treated; 112 Subjects COMS One device treated) to account for approximately 10% missing data due to early trial withdrawal or missed endpoint assessment.
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Inclusion criteria
Exclusion criteria
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 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)
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)
Blood chemistry or counts values as follows (based on subject's medical files):
Primary purpose
Allocation
Interventional model
Masking
450 participants in 2 patient groups
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Central trial contact
Bernard Laurel; Rejelle Williams
Data sourced from clinicaltrials.gov
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