Betafoam Diabetes Mellitus Foot Study

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Foot Ulcer
• Intervention / Treatment: Device: Betafoam®; Device: Medifoam®

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Inje University Sanggye Paik Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Betafoam®; Brand name: Betafoam® Generic term: Wound dressing with 3% povidone iodine	Device: Betafoam®; Foam dressing including Betadine iodine; Other Names: Betafoam
ACTIVE_COMPARATOR: Medifoam®; Brand name: Medifoam® Generic term: Wound dressing	Device: Medifoam®; Foam Dressing; Other Names: Medifoam

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Number of days till completion of wound healing from baseline		8 weeks
Total number of the dressing change and mean number of dressing change per day compared to wound healing period		8 weeks
Safety as determined through collection of adverse events		8 weeks
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

Collaborators and Investigators

• Sponsor: Mundipharma Korea Ltd
• Investigators: Principal Investigator: Hyongjin Jung, Dr. PhD., Inje University Sangye Paik Hospital,

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 29, 2016
• Primary Completion (ACTUAL): September 29, 2017
• Study Completion (ACTUAL): September 29, 2017

Study Registration Dates

• First Submitted: March 15, 2016
• First Submitted That Met QC Criteria: April 4, 2016
• First Posted (ESTIMATE): April 11, 2016

Study Record Updates

• Last Update Posted (ACTUAL): November 30, 2017
• Last Update Submitted That Met QC Criteria: November 29, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: foam dressing
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Skin Diseases; Endocrine System Diseases; Leg Ulcer; Skin Ulcer; Foot Diseases; Diabetes Mellitus; Foot Ulcer
• Other Study ID Numbers: BTF15-KR-402

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED