Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
71 participants
INTERVENTIONAL
2016-03-29
2017-09-29
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Betafoam®
Brand name: Betafoam® Generic term: Wound dressing with 3% povidone iodine
Betafoam®
Foam dressing including Betadine iodine
Medifoam®
Brand name: Medifoam® Generic term: Wound dressing
Medifoam®
Foam Dressing
Interventions
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Medifoam®
Foam Dressing
Betafoam®
Foam dressing including Betadine iodine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
19 Years
ALL
No
Sponsors
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Mundipharma Korea Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Hyongjin Jung, Dr. PhD.
Role: PRINCIPAL_INVESTIGATOR
Inje University Sangye Paik Hospital,
Locations
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Inje University Sanggye Paik Hospital
Seoul, , South Korea
Countries
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References
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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.
Other Identifiers
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BTF15-KR-402
Identifier Type: -
Identifier Source: org_study_id