Diabetes Mellitus Clinical Trial
Official title:
A Pilot Study to Compare Efficacy of Medifoam® and Betafoam® as a New Dressing Including Povidone-iodine, in Patients With Diabetes Foot Ulcer
Verified date | November 2017 |
Source | Mundipharma Korea Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 71 |
Est. completion date | September 29, 2017 |
Est. primary completion date | September 29, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Inje University Sanggye Paik Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Mundipharma Korea Ltd |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | 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 | 8 weeks | |
Secondary | 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 | |
Secondary | Number of days till completion of wound healing from baseline | 8 weeks | ||
Secondary | Total number of the dressing change and mean number of dressing change per day compared to wound healing period | 8 weeks | ||
Secondary | Safety as determined through collection of adverse events | 8 weeks | ||
Secondary | 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 |
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