Betafoam Diabetes Mellitus Foot Study

Study Overview
=================
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.

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

Conditions
-----------------
Diabetes Mellitus, Foot Ulcer

Intervention / Treatment
-----------------
* Device: Medifoam®
* Device: Betafoam®


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Betafoam®<br>Brand name: Betafoam® Generic term: Wound dressing with 3% povidone iodine | Device: Betafoam®<br>* Foam dressing including Betadine iodine<br>* Other names: Betafoam;|
| Active Comparator: Medifoam®<br>Brand name: Medifoam® Generic term: Wound dressing | Device: Medifoam®<br>* Foam Dressing<br>* Other names: Medifoam;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Safety as determined through collection of adverse events |  | 8 weeks | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
foam dressing