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 Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Open, Non-comparative, Multi-centre Post Marketing Clinical Follow-up Investigation to Evaluate Performance and Safety on Diabetic Foot Ulcer, DFU When Using Fast Gelling Dressing as Intended.

NCT02091778

Diabetic Foot Ulcers

COMPLETED NA

A Prospective, Open, Non-controlled Clinical Investigation to Evaluate the Performance and Safety of an Antimicrobial Foam Transferring Dressing in Patients With Malignant Wounds

NCT02431741

Malignant Wounds

COMPLETED NA

Open Multi-centre Investigation to Evaluate Signs and Symptoms of Local Inflammation/Infection on Chronic Ulcers and Partial Thickness Burns When Using Mepilex Border Ag as an Anti-microbial Wound Dressing

NCT01214811

Inflammation Burns Ulcers

COMPLETED PHASE3

Evaluation of Negative Pressure Wound Therapy in the Treatment of DFUs Incl. Post Amputation Wounds.

NCT01011387

Diabetes Foot Ulcers

COMPLETED NA

Evaluating the Efficacy of an Absorbent Foam Dressing Containing Silver (Mepilex Ag) Versus the Same Dressing Without Silver Used on Subjects With Venous Leg Ulcers or Mixed Ulcers

NCT01036438

Venous Leg Ulcers Mixed Leg Ulcers

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetic Foot Ulcers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Mepilex Transfer Ag

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mepilex Transfer Ag

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No