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Completed

NCT Number: NCT02732886

Betafoam Diabetes Mellitus Foot Study

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Foot Diseases Foot Ulcer Glucose Metabolism Disorders Leg Ulcer Metabolic Diseases Nutritional and Metabolic Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inje University Sanggye Paik Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Medifoam®

Device

Foam Dressing

Other names: Medifoam

Betafoam®

Device

Foam dressing including Betadine iodine

Other names: Betafoam

Primary outcomes

  1. Proportion of subjects with a target ulcer which achieves complete wound closure in 8 weeks

    Time frame: 8 weeks

    Skin re-epithelialization without drainage or dressing requirements

Secondary outcomes

  1. Proportion of subjects with a target ulcer which achieves complete wound closure in 4 weeks

    Time frame: 4 weeks

    Skin re-epithelialization without drainage or dressing requirements

  2. Wound infection rate until completion of skin re-epithelialization

    Time frame: 8 weeks

    Wound infection rate until the completion of skin re-epithelialization in each subject by recording the signs and symptoms of infection at every visit

  3. Patient's level of satisfaction with treatment measured weekly using numeric rating scale (NRS)

    Time frame: 8 weeks

    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.

  4. Number of days till completion of wound healing from baseline

    Time frame: 8 weeks

  5. Total number of the dressing change and mean number of dressing change per day compared to wound healing period

    Time frame: 8 weeks

  6. Safety as determined through collection of adverse events

    Time frame: 8 weeks

  7. Change amount and change rate of the target ulcer size after using the investigational device

    Time frame: 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Mundipharma Korea Ltd

Industry

Registry information

Official study title

A Pilot Study to Compare Efficacy of Medifoam® and Betafoam® as a New Dressing Including Povidone-iodine, in Patients With Diabetes Foot Ulcer

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 11, 2016
Registry last updated
Nov 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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