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This study is to compare the efficacy and safety of MedifoamĀ® and BetafoamĀ®, 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BetafoamĀ® | Experimental | Brand name: BetafoamĀ® Generic term: Wound dressing with 3% povidone iodine |
|
| MedifoamĀ® | Active Comparator | Brand name: MedifoamĀ® Generic term: Wound dressing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MedifoamĀ® | Device | Foam Dressing |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with a target ulcer which achieves complete wound closure in 8 weeks | Skin re-epithelialization without drainage or dressing requirements | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with a target ulcer which achieves complete wound closure in 4 weeks | Skin re-epithelialization without drainage or dressing requirements | 4 weeks |
| Wound infection rate until completion of skin re-epithelialization |
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Inclusion Criteria:
Adult of age ā„19 years at the time of informed consent
Foot ulcers related to diabetes mellitus:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Hyongjin Jung, Dr. PhD. | Inje University Sangye Paik Hospital, | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University Sanggye Paik Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31773882 | Derived | Gwak HC, Han SH, Lee J, Park S, Sung KS, Kim HJ, Chun D, Lee K, Ahn JH, Kwak K, Chung HJ. Efficacy of a povidone-iodine foam dressing (Betafoam) on diabetic foot ulcer. Int Wound J. 2020 Feb;17(1):91-99. doi: 10.1111/iwj.13236. Epub 2019 Nov 26. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D016523 | Foot Ulcer |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| BetafoamĀ® |
| Device |
Foam dressing including Betadine iodine |
|
|
Wound infection rate until the completion of skin re-epithelialization in each subject by recording the signs and symptoms of infection at every visit
| 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. | 8 weeks |
| Number of days till completion of wound healing from baseline | 8 weeks |
| Total number of the dressing change and mean number of dressing change per day compared to wound healing period | 8 weeks |
| 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 | 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. | 8 weeks |
| D005534 | Foot Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |