The study will evaluate the treatment effect of MDI-1228-mesylate Gel compared with standard of care alone for the complete healing rate at the end of 12 weeks in participants with diabetic foot ulcers (targeted ulcer). In addition, the proportion of subjects whose target ulcer area is reduced by 50% after 12 weeks of treatment.
The study is targeted to enroll approximately sixty subjects with diabetic foot ulcers. All subjects will be randomized at baseline visits at a 2:1 ratio to either receive the study treatment plus standard of care or standard of care alone. All subjects who meet inclusion/exclusion criteria will have all ulcers treated; however, only one ulcer, the largest, will be selected as the target ulcer. Before performing any study procedures, all potential subjects will sign an informed consent form (ICF). The total study duration is anticipated to be up to 18 weeks, including: * Up to a 14-day screening period * Up to 12 weeks study treatment * Up to 4 weeks of follow-up * End-of-treatment visit will be performed on the last day of treatment (D84) * End-of-Study visit will be performed at the follow-up visit (D112) Wound photography should be dedicated to one study site personnel to control variance.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Approximately 40 subjects will receive 0.75% MDI-1228\_mesylate gel twice daily for 12 weeks.
Approximately 20 subjects will receive the standard of care alone including wound cleaning, debribement and other additional care decided by the healthcare provider.
Site 001
Durham, North Carolina, United States
RECRUITINGDrug related treatment emergent adverse events
Incidence (severity and causality) of any drug related local and systemic treatment emergent adverse events (TEAE) for 12 weeks during the study treatment.
Time frame: 1-12 weeks
Complete Healing and Time to closure for targeted diabetic foot ulcer
The proportion of subjects with complete healing of the target ulcer area after 12 weeks of treatment
Time frame: 1-12 weeks
Ulcer area reduced by 50%
The proportion of subjects whose ulcer area was reduced by 50% after 12 weeks of treatment. \[The ulcer area will be calculated using a photograph of the ulcer area and PI assessment.\]
Time frame: 12 weeks
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