This study is to evaluate the efficacy of OCM™ used in combination with off-loading devices for the treatment of diabetic foot ulcers.
The study will include three phases: screening phase, treatment phase and healing confirmation. All measurements in the trial are captured by Tissue Analytics.The two week screening phase is to confirm the chronicity of the diabetic foot ulcer (DFU) and the eligibility of subjects. Subjects will be treated with standard of care (SOC) which includes cleaning of the wound, debridement when needed, dressing, and offloading. If the ulcer decreases by 30% in area measurement after 2 weeks of SOC, then the subject does not qualify for the treatment phase. The treatment phase begins with assessment to confirm continued eligibility and if met, subjects are treated weekly with the OCM™ therapy plus continued offloading. At the conclusion of 4 weekly treatments, the ulcer will be assessed by PI for response and evaluation of percent area reduction. Continued therapy through treatment visit 12 is at the PI's discretion where percent area reduction is assessed and recorded. OCM™ results will be compared to a Control Group of subjects identified and matched retrospectively from the same site, who received the same advanced treatments that the OCM™ treated cohort had received prior to the trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
The three omeza products were designed to be used in combination for the treatment of chronic wounds
Jobst Vascular Institute
Toledo, Ohio, United States
Percent area change after 4 weeks of treatment compared to baseline
After a 2 week screening phase with standard of care and total contact casting, the wound will be measured and assessed by Tissue Analytics platform. At each treatment visit the change in the wound size and healing status will be assessed. After 4 weeks of treatment the change in wound size will be compared to baseline measurement from treatment visit 1 and the percent area reduction (PAR) recorded.
Time frame: 6 weeks
Incidence in wound closure by week 12 of treatment
Treatment will continue and measurements recorded by Tissue Analytics platform until wound closure or up to 12 weeks of treatment.
Time frame: 14 weeks
Incidence of adverse events
Safety of the products used in combination will be assessed by the PI and assesses throughout treatment for adverse events or reactions to the products.
Time frame: 14 weeks
Change in subject's perception of pain at baseline and weekly throughout treatment
Subjects will be required to assess ulcer pain at baseline and at each treatment visit by a questionnaire assessing pain on a numerical scale
Time frame: 14 weeks
Increase in physical function and ambulation
Subjects will be asked to complete a questionnaire to assess physical function and ambulation status at baseline and at each treatment visit.
Time frame: 14 weeks
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