Betafoam Diabetes Mellitus Foot Study

Mundipharma

Status: Completed

Conditions: Foot Ulcer; Diabetes Mellitus

Treatments: Device: Betafoam®; Device: Medifoam®

Study type: Interventional

Funder types: Industry

Identifiers

NCT02732886

BTF15-KR-402

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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71 participants in 2 patient groups

Betafoam®

Experimental group

Description:

Brand name: Betafoam® Generic term: Wound dressing with 3% povidone iodine

Treatment:

Device: Betafoam®

Medifoam®

Active Comparator group

Description:

Brand name: Medifoam® Generic term: Wound dressing

Treatment:

Device: Medifoam®