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 (MxT Ag 05)

Molnlycke Health Care

Status: Completed

Conditions: Diabetic Foot Ulcers

Treatments: Device: Mepilex Transfer Ag

Study type: Interventional

Funder types: Industry

Identifiers

NCT01964521

MxT Ag 05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Mepilex Transfer Ag

Experimental group

Description:

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.

Treatment:

Device: Mepilex Transfer Ag