Diabetes Mellitus, Foot Ulcer
Conditions
Keywords
foam dressing
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.
Interventions
DEVICEMedifoam®
Foam Dressing
DEVICEBetafoam®
Foam dressing including Betadine iodine
Sponsors
Mundipharma Korea Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| Number of days till completion of wound healing from baseline | 8 weeks | — |
| 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 |
| Safety as determined through collection of adverse events | 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. |
| Total number of the dressing change and mean number of dressing change per day compared to wound healing period | 8 weeks | — |
Countries
South Korea
Outcome results
None listed