Betafoam Diabetes Mellitus Foot Study
- Conditions
- Diabetes MellitusFoot Ulcer
- Interventions
- Device: Betafoam®Device: Medifoam®
- Registration Number
- NCT02732886
- Lead Sponsor
- Mundipharma Korea Ltd
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 71
-
Adult of age ≥19 years at the time of informed consent
-
Foot ulcers related to diabetes mellitus:
- Present
- Type I or II diabetes mellitus with HbA1c <10%, or serum creatinine ≤ 200 μmol/l
- Wagner grade I-II (Partial- or full- thickness and not involving bone, tendon, or capsule (probing to tendon or capsule)
- Post -debridement ulcer bed size ≥ 1*1cm2
-
No clinical signs of infection & necrosis
-
Site at anywhere below ankle
-
No vascular abnormalities of the foot by palpation (i.e. the dorsalis pedis should be examined by the physician and characterized as present or absent)
- Pregnant & lactating females
- Known allergy to the dressing product including povidone iodine
- Known hyperthyroidism or other acute thyroid diseases
- Subject with clinical infection who should be administered antibiotics continuously after enrolment
- Subject has any condition(s) that seriously compromises the patient's ability to complete this study.
- Subject has participated in interventional study utilizing an investigational drug within the previous 30 days
- Subjects with known immune-suppressed state; who undergo chemotherapy or with end-stage renal disease requiring haemodialysis or had kidney transplant surgery previously and with immunosuppressant specifically
- Subjects requiring skin grafting per physician's discretion
- Vulnerable subjects as defined by Good Clinical Practice guidelines.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Betafoam® Betafoam® Brand name: Betafoam® Generic term: Wound dressing with 3% povidone iodine Medifoam® Medifoam® Brand name: Medifoam® Generic term: Wound dressing
- Primary Outcome Measures
Name Time Method Proportion of subjects with a target ulcer which achieves complete wound closure in 8 weeks 8 weeks Skin re-epithelialization without drainage or dressing requirements
- Secondary Outcome Measures
Name Time Method Proportion of subjects with a target ulcer which achieves complete wound closure in 4 weeks 4 weeks Skin re-epithelialization without drainage or dressing requirements
Wound infection rate until completion of skin re-epithelialization 8 weeks Wound infection rate until the completion of skin re-epithelialization in each subject by recording the signs and symptoms of infection at every visit
Number of days till completion of wound healing from baseline 8 weeks Safety as determined through collection of adverse events 8 weeks Patient's level of satisfaction with treatment measured weekly using numeric rating scale (NRS) 8 weeks 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.
Total number of the dressing change and mean number of dressing change per day compared to wound healing period 8 weeks Change amount and change rate of the target ulcer size after using the investigational device 8 weeks 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.
Trial Locations
- Locations (1)
Inje University Sanggye Paik Hospital
🇰🇷Seoul, Korea, Republic of