NCT02732886

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2016

Completed
14 days until next milestone

Study Start

First participant enrolled

March 29, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 11, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2017

Completed
Last Updated

November 30, 2017

Status Verified

November 1, 2017

Enrollment Period

1.5 years

First QC Date

March 15, 2016

Last Update Submit

November 29, 2017

Conditions

Diabetes MellitusFoot Ulcer

Keywords

foam dressing

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

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

    4 weeks

  • Wound infection rate until completion of skin re-epithelialization

    8 weeks

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

    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

  • +2 more secondary outcomes

Study Arms (2)

Betafoam®

EXPERIMENTAL

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

Device: Betafoam®

Medifoam®

ACTIVE COMPARATOR

Brand name: Medifoam® Generic term: Wound dressing

Device: Medifoam®

Interventions

Medifoam®DEVICE

Foam Dressing

Also known as: Medifoam
Medifoam®
Betafoam®DEVICE

Foam dressing including Betadine iodine

Also known as: Betafoam
Betafoam®

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inje University Sanggye Paik Hospital

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 31773882DERIVED

MeSH Terms

Conditions

Diabetes MellitusFoot Ulcer

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesFoot DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLeg UlcerSkin Ulcer

Study Officials

  • Hyongjin Jung, Dr. PhD.

    Inje University Sangye Paik Hospital,

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2016

First Posted

April 11, 2016

Study Start

March 29, 2016

Primary Completion

September 29, 2017

Study Completion

September 29, 2017

Last Updated

November 30, 2017

Record last verified: 2017-11

Locations

KR(1)