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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01964521
Recruitment Status : Completed
First Posted : October 17, 2013
Results First Posted : August 10, 2018
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
Molnlycke Health Care AB

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcers Device: Mepilex Transfer Ag Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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 Start Date : February 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Mepilex Transfer Ag
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
A soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.


Outcome Measures
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Primary Outcome Measures :
  1. Changes in Signs and Symptoms of Local Infection [ Time Frame: 4 weeks ]
    Evaluation of signs of infection (exudate) from baseline


Secondary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01964521


Locations
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United Kingdom
The Norfolk & Norwich University Hospitals NHS foundation
Norwich, Colney Lane, United Kingdom, NR4 7UY
The Rotherham NHS Foundation Trust
Rotherham, United Kingdom, S60 2UD
Sponsors and Collaborators
Molnlycke Health Care AB
Investigators
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Principal Investigator: Ketan Dhatariya, Doctor Norfolk & Norwich University Hospitals NHS foundation
More Information
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Responsible Party: Molnlycke Health Care AB
ClinicalTrials.gov Identifier: NCT01964521    
Other Study ID Numbers: MxT Ag 05
First Posted: October 17, 2013    Key Record Dates
Results First Posted: August 10, 2018
Last Update Posted: August 10, 2018
Last Verified: February 2014
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
 Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases