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

Not Applicable

Completed

• Conditions: Diabetic Foot Ulcers

• Registration Number: NCT01964521
• Lead Sponsor: Molnlycke Health Care AB

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2013-09-30
• Study First Submitted QC: 2013-10-14
• Study First Posted: 2013-10-17
• Status Verified: 2014-02
• Study Start: 2014-02
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Results First Submitted: 2017-04-19
• Results First Submitted QC: 2017-11-03
• Last Update Submitted: 2017-11-03
• Results First Posted: 2018-08-10
• Last Update Posted: 2018-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Both gender>=18 years old
2. Subjects with type 1 or 2 diabetes mellitus
3. Two of the signs of infection must be present and recorded (redness, heat, oedema, pain, increased exudates amount, deteriorating wound, fever, odour)
4. Ulcer localization; below the ankle
5. Signed Informed Consent

Exclusion Criteria

1. Dry wound
2. Known allergy/hypersensitivity to the dressing
3. Treated with other Silver dressing on the ulcer target within 1 week prior to this investigation
4. Subjects who will have problems following the clinical investigation plan
5. Subjects enrolled in the investigation already
6. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Changes in Signs and Symptoms of Local Infection	4 weeks	Evaluation of signs of infection (exudate) from baseline

Secondary Outcome Measures

Name	Time	Method
Levels of Pain in Connection to Dressing Changes.	4 weeks	Levels of pain measured by VAS, visual analog scale. 1 to 100 mm, 1= low pain, 100= worse pain.

Trial Locations

Locations (2)

The Norfolk & Norwich University Hospitals NHS foundation; 🇬🇧 Norwich, Colney Lane, United Kingdom

The Rotherham NHS Foundation Trust; 🇬🇧 Rotherham, United Kingdom