Clinical trial NCT02732886: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Foot Ulcer
Keywords: foam dressing
Lead sponsor: Mundipharma Korea Ltd
Sponsor class: INDUSTRY
First posted: 2016-04-11
Enrollment: 71
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Proportion of subjects with a target ulcer which achieves complete wound closure in 8 weeks
timeFrame: 8 weeks
Secondary outcomes:
measure: Proportion of subjects with a target ulcer which achieves complete wound closure in 4 weeks
timeFrame: 4 weeks
measure: Wound infection rate until completion of skin re-epithelialization
timeFrame: 8 weeks
measure: Patient's level of satisfaction with treatment measured weekly using numeric rating scale (NRS)
timeFrame: 8 weeks
measure: Number of days till completion of wound healing from baseline
timeFrame: 8 weeks
measure: Total number of the dressing change and mean number of dressing change per day compared to wound healing period
timeFrame: 8 weeks
measure: Safety as determined through collection of adverse events
timeFrame: 8 weeks
measure: Change amount and change rate of the target ulcer size after using the investigational device
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Inje University Sanggye Paik Hospital
Study officials:
affiliation: Inje University Sangye Paik Hospital,
name: Hyongjin Jung, Dr. PhD.
role: PRINCIPAL_INVESTIGATOR
References:
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.