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Diabetes MellitusNCT02732886

Betafoam Diabetes Mellitus Foot Study

A study testing Medifoam® and Betafoam® in people with Diabetes Mellitus and Foot Ulcer, run by Mundipharma Korea Ltd at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Diabetes Mellitus, Foot Ulcer
What is being tested?
Medifoam® and Betafoam®
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
1 siteSouth Korea
Study dates
29 Mar 2016to 29 Sep 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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)

Who cannot join

  • 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
Show all 9Show fewer
  • 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 locations and contacts

1 site in 1 country.

South Korea1 site

  • Inje University Sanggye Paik Hospital

    Seoul

Other trials in South Korea

About this 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

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.

Being tested
Medifoam®, Betafoam®
Keywords
foam dressing
Medical subject headings
Diabetes Mellitus, Foot Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medifoam®Device

    Also called Medifoam

    Foam Dressing

  • Betafoam®Device

    Also called Betafoam

    Foam dressing including Betadine iodine

Study groups in NCT02732886
Study groupRoleWhat they receive
Betafoam®ExperimentalBrand name: Betafoam® Generic term: Wound dressing with 3% povidone iodine
Receives: Device: Betafoam®
Medifoam®Active comparatorBrand name: Medifoam® Generic term: Wound dressing
Receives: Device: Medifoam®

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Skin re-epithelialization without drainage or dressing requirements

    Measured: 8 weeks

Secondary outcomes (7)

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

    Skin re-epithelialization without drainage or dressing requirements

    Measured: 4 weeks

  2. 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

    Measured: 8 weeks

  3. 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.

    Measured: 8 weeks

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

    Measured: 8 weeks

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

    Measured: 8 weeks

  6. Safety as determined through collection of adverse events

    Measured: 8 weeks

  7. 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.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2016 (estimated)
  2. Study start29 Mar 2016
  3. Primary completion29 Sep 2017
  4. Study completion29 Sep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02732886
Sponsor's protocol ID
BTF15-KR-402
Status last verified
Nov 2017
First submitted
15 Mar 2016
Last updated
30 Nov 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

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.

    PubMed 31773882

Questions about this trial

What is this clinical trial studying?

A study testing Medifoam® and Betafoam® in people with Diabetes Mellitus and Foot Ulcer, run by Mundipharma Korea Ltd at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects with a target ulcer which achieves complete wound closure in 8 weeks (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02732886, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2017.

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