Betafoam Diabetes Mellitus Foot Study

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02732886
• Other study ID #: BTF15-KR-402
• Status: Completed
• Phase: N/A
• First received: March 15, 2016
• Last updated: November 29, 2017
• Start date: March 29, 2016
• Est. completion date: September 29, 2017

Study information

• Verified date: November 2017
• Source: Mundipharma Korea Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: September 29, 2017
• Est. primary completion date: September 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Foot Ulcer

Intervention

Device:
• Medifoam®
Foam Dressing
• Betafoam®
Foam dressing including Betadine iodine

Locations

Country	Name	City	State
Korea, Republic of	Inje University Sanggye Paik Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Mundipharma Korea Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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