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

Diabetic Foot Ulcers Clinical Trial

— MxT Ag 05  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01964521
• Other study ID #: MxT Ag 05
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: April 2015

Study information

• Verified date: February 2014
• Source: Molnlycke Health Care AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcers
• Foot Ulcer
• Ulcer

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	The Norfolk & Norwich University Hospitals NHS foundation	Norwich	Colney Lane
United Kingdom	The Rotherham NHS Foundation Trust	Rotherham

Sponsors (1)

Lead Sponsor	Collaborator
Molnlycke Health Care AB

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Signs and Symptoms of Local Infection	Evaluation of signs of infection (exudate) from baseline	4 weeks
Secondary	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