Clinical trial 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcers
Lead sponsor: Molnlycke Health Care AB
Sponsor class: INDUSTRY
First posted: 2013-10-17
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Changes in Signs and Symptoms of Local Infection
timeFrame: 4 weeks
Secondary outcomes:
measure: Levels of Pain in Connection to Dressing Changes.
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Norwich
country: United Kingdom
facility: The Norfolk & Norwich University Hospitals NHS foundation
state: Colney Lane
city: Rotherham
country: United Kingdom
facility: The Rotherham NHS Foundation Trust
Study officials:
affiliation: Norfolk & Norwich University Hospitals NHS foundation
name: Ketan Dhatariya, Doctor
role: PRINCIPAL_INVESTIGATOR
References: