TITLE: An Open, Non-comparative, Multi-centre Post Marketing Clinical Follow-up (PMCF) Investigation to Evaluate Performance and Safety on Diabetic Foot Ulcer, DFU, When Using Mepilex Transfer Ag as Intended

Study Overview
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Brief Summary
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An open, non-comparative, multi-centre post marketing clinical follow-up, PMCF, investigation to evaluate performance and safety on diabetic foot ulcer, dfu, when using mepilex transfer Ag as intended.

Detailed Description
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Approximately 25-30 subjects from two to three centers will be evaluated provided they fulfill the inclusion criteria and none of the exclusion criteria and gives a signed and dated consent. Subjects to be included were to suffer from a DFU and being in need of anti-microbial wound dressing. Dressing changes were to performed according to the local clinical routine (usually 3 times/week), evaluated during a total treatment period of maximum 4 weeks including weekly visits when assessments were being done. A record (dressing log) for Mepilex Transfer Ag and outer layers were to be filled in at every dressing change. Photos taken directly upon dressing removal and after cleansing /debridement were to be collected to visually follow the ulcers status. At each visit the investigators/nurse and subjects opinion (using an evaluation form) were to be asked for questions considering the use of Mepilex Transfer Ag. Pain before, during and after removal will be assessed.

Official Title
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An Open, Non-comparative, Multi-centre Post Marketing Clinical Follow-up (PMCF) Investigation to Evaluate Performance and Safety on Diabetic Foot Ulcer, DFU, When Using Mepilex Transfer Ag as Intended

Conditions
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Diabetic Foot Ulcers

Intervention / Treatment
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* Device: Mepilex Transfer Ag


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both gender>=18 years old Subjects with type 1 or 2 diabetes mellitus Two of the signs of infection must be present and recorded (redness, heat, oedema, pain, increased exudates amount, deteriorating wound, fever, odour) Ulcer localization; below the ankle Signed Informed Consent Exclusion Criteria: Dry wound Known allergy/hypersensitivity to the dressing Treated with other Silver dressing on the ulcer target within 1 week prior to this investigation Subjects who will have problems following the clinical investigation plan Subjects enrolled in the investigation already Subjects included in other ongoing clinical investigation at present or during the past 30 days. Subjects participating in a clinical sample investigation might be enrolled in the investigation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mepilex Transfer Ag<br>Mepilex Transfer Ag is a transfer dressing designed for low to high exuding wounds and used to prevent microbial growth. It is worn for up to two weeks at a time. | Device: Mepilex Transfer Ag<br>* A soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Signs and Symptoms of Local Infection | Evaluation of signs of infection (exudate) from baseline | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of Pain in Connection to Dressing Changes. | Levels of pain measured by VAS, visual analog scale. 1 to 100 mm, 1= low pain, 100= worse pain. | 4 weeks |