Betafoam Diabetes Mellitus Foot Study

Launched by MUNDIPHARMA KOREA LTD · Apr 4, 2016

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• 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.