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OpenTrials
Completed

NCT Number: NCT01964521

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mepilex Transfer Ag

Device

A soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.

Primary outcomes

  1. Changes in Signs and Symptoms of Local Infection

    Time frame: 4 weeks

    Evaluation of signs of infection (exudate) from baseline

Secondary outcomes

  1. Levels of Pain in Connection to Dressing Changes.

    Time frame: 4 weeks

    Levels of pain measured by VAS, visual analog scale. 1 to 100 mm, 1= low pain, 100= worse pain.

Sponsors and collaborators

Lead sponsor

Molnlycke Health Care AB

Industry

Registry information

Official study 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

Acronym: MxT Ag 05

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 17, 2013
Registry last updated
Aug 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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