This study is to compare the efficacy and safety of Medifoam® and Betafoam®, which is a new dressing that contains povidone-iodine, in patients with diabetes foot ulcer. 70 patients (35 each arm) are targeted to be enrolled in this study. Treatment follow periods are 8weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
71
Inje University Sanggye Paik Hospital
Seoul, South Korea
Proportion of subjects with a target ulcer which achieves complete wound closure in 8 weeks
Skin re-epithelialization without drainage or dressing requirements
Time frame: 8 weeks
Proportion of subjects with a target ulcer which achieves complete wound closure in 4 weeks
Skin re-epithelialization without drainage or dressing requirements
Time frame: 4 weeks
Wound infection rate until completion of skin re-epithelialization
Wound infection rate until the completion of skin re-epithelialization in each subject by recording the signs and symptoms of infection at every visit
Time frame: 8 weeks
Patient's level of satisfaction with treatment measured weekly using numeric rating scale (NRS)
Level of patient's satisfaction with the application and removal of dressing, as measured using numeric rating scale (NRS). This is done weekly from Visits 3 to 17.
Time frame: 8 weeks
Number of days till completion of wound healing from baseline
Time frame: 8 weeks
Total number of the dressing change and mean number of dressing change per day compared to wound healing period
Time frame: 8 weeks
Safety as determined through collection of adverse events
Time frame: 8 weeks
Change amount and change rate of the target ulcer size after using the investigational device
The area of the target ulcer is calculated with a film drawn to the shape of the wound at the target ulcer, by using the Visitrak digital planimetry.
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Time frame: 8 weeks