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Betafoam Diabetes Mellitus Foot Study

Primary Purpose

Diabetes Mellitus, Foot Ulcer

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Medifoam®
Betafoam®
Sponsored by
Mundipharma Korea Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring foam dressing

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Inje University Sanggye Paik Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Betafoam®

Medifoam®

Arm Description

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

Brand name: Medifoam® Generic term: Wound dressing

Outcomes

Primary Outcome Measures

Proportion of subjects with a target ulcer which achieves complete wound closure in 8 weeks
Skin re-epithelialization without drainage or dressing requirements

Secondary Outcome Measures

Proportion of subjects with a target ulcer which achieves complete wound closure in 4 weeks
Skin re-epithelialization without drainage or dressing requirements
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
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.
Number of days till completion of wound healing from baseline
Total number of the dressing change and mean number of dressing change per day compared to wound healing period
Safety as determined through collection of adverse events
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.

Full Information

First Posted
March 15, 2016
Last Updated
November 29, 2017
Sponsor
Mundipharma Korea Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02732886
Brief Title
Betafoam Diabetes Mellitus Foot Study
Official Title
A Pilot Study to Compare Efficacy of Medifoam® and Betafoam® as a New Dressing Including Povidone-iodine, in Patients With Diabetes Foot Ulcer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
March 29, 2016 (Actual)
Primary Completion Date
September 29, 2017 (Actual)
Study Completion Date
September 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mundipharma Korea Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Foot Ulcer
Keywords
foam dressing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Betafoam®
Arm Type
Experimental
Arm Description
Brand name: Betafoam® Generic term: Wound dressing with 3% povidone iodine
Arm Title
Medifoam®
Arm Type
Active Comparator
Arm Description
Brand name: Medifoam® Generic term: Wound dressing
Intervention Type
Device
Intervention Name(s)
Medifoam®
Other Intervention Name(s)
Medifoam
Intervention Description
Foam Dressing
Intervention Type
Device
Intervention Name(s)
Betafoam®
Other Intervention Name(s)
Betafoam
Intervention Description
Foam dressing including Betadine iodine
Primary Outcome Measure Information:
Title
Proportion of subjects with a target ulcer which achieves complete wound closure in 8 weeks
Description
Skin re-epithelialization without drainage or dressing requirements
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Proportion of subjects with a target ulcer which achieves complete wound closure in 4 weeks
Description
Skin re-epithelialization without drainage or dressing requirements
Time Frame
4 weeks
Title
Wound infection rate until completion of skin re-epithelialization
Description
Wound infection rate until the completion of skin re-epithelialization in each subject by recording the signs and symptoms of infection at every visit
Time Frame
8 weeks
Title
Patient's level of satisfaction with treatment measured weekly using numeric rating scale (NRS)
Description
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.
Time Frame
8 weeks
Title
Number of days till completion of wound healing from baseline
Time Frame
8 weeks
Title
Total number of the dressing change and mean number of dressing change per day compared to wound healing period
Time Frame
8 weeks
Title
Safety as determined through collection of adverse events
Time Frame
8 weeks
Title
Change amount and change rate of the target ulcer size after using the investigational device
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyongjin Jung, Dr. PhD.
Organizational Affiliation
Inje University Sangye Paik Hospital,
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inje University Sanggye Paik Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31773882
Citation
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.
Results Reference
derived

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Betafoam Diabetes Mellitus Foot Study

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