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

NCT01964521 | Completed Results

• 1 other identifier: MxT Ag 05
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetic Foot Ulcers

Outcome Measures

Primary Outcomes (1)

• Changes in Signs and Symptoms of Local Infection

  Evaluation of signs of infection (exudate) from baseline

  4 weeks

Secondary Outcomes (1)

• Levels of Pain in Connection to Dressing Changes.

  4 weeks

Study Arms (1)

Mepilex Transfer Ag

EXPERIMENTAL

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

Interventions

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.

Mepilex Transfer Ag

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Molnlycke Health Care AB: lead

Study Sites (2)

The Norfolk & Norwich University Hospitals NHS foundation

Norwich, Colney Lane, NR4 7UY, United Kingdom

Location

The Rotherham NHS Foundation Trust

Rotherham, S60 2UD, United Kingdom

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Results Point of Contact

• Title: Dr Ketan Dhatariya
• Organization: The Norfolk & Norwich University Hospitals NHS Foundation Trust

ketan.dhatariya@nnuh.nhs.uk

+44 1603 286286

Study Officials

• Ketan Dhatariya, Doctor

  Norfolk & Norwich University Hospitals NHS foundation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2013
• First Posted: October 17, 2013
• Study Start: February 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: August 10, 2018
• Results First Posted: August 10, 2018

Record last verified: 2014-02

Locations

GB (2)