What is Mepilex Up studying for chronic wounds like venous leg ulcers and diabetic foot ulcers?

Mepilex Up is being studied to observe how it affects the healing progress of chronic wounds with significant drainage. Researchers want to understand wound healing changes while using this absorbent dressing. The study is sponsored by Molnlycke Health Care AB to gather detailed wound healing information under medical supervision.

Who may be eligible for this chronic wounds clinical trial?

Adults aged 18 or older with diagnosed chronic venous leg ulcers or diabetic foot ulcers that produce moderate to large amounts of drainage may be eligible. Participants must have specific wound sizes and be willing to use compression therapy if they have venous leg ulcers. Please review eligibility criteria for more details.

Is there any cost to participate in this chronic wounds clinical trial?

Study-related care, including the study dressing and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan for their own travel needs during the study period.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID05588583

A Prospective, Open, Multi-Center, Interventional Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex Up

Led by Molnlycke Health Care AB · Updated on 2023-04-20

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the progress of chronic wounds, specifically venous leg ulcers VLU and diabetic foot ulcers DFU, using an absorbent dressing called Mepilex Up. This study is a prospective, open, multi-center, interventional trial designed to observe wound healing over a period of up to six weeks. The goal is to track changes in wound area and condition while participants receive treatment according to local standards of care. Participants will use the Mepilex Up dressing, which is a soft, silicone-based absorbent foam dressing designed to manage wound exudate and protect the skin. The dressing will be applied as the primary dressing and changed weekly for up to six weeks or until the wound heals. The study includes seven visits a baseline visit followed by weekly visits to monitor wound healing and dressing performance. During each visit, researchers will assess wound progress through measurements and evaluations of wound area, volume, tissue quality, exudate, and skin condition. Participants will report on pain, comfort, and quality of life related to wound care. Safety will be monitored at all visits. The total treatment period is a maximum of 44 days or until healing occurs, with detailed tracking of dressing wear time, wound changes, and any adverse events.

CONDITIONS

Brief Title

A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing.

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Signed consent to participate, including consent for digital imaging
Adult aged �3e= 18 years
Diagnosed with a chronic, exuding venous leg ulcer or diabetic foot ulcer
Moderate to large amount of wound drainage (exudate)
Wound size from 3 cm2 to 30 cm2 for venous leg ulcers and �3e= 1 cm2 for diabetic foot ulcers
For venous leg ulcers: ABPI within 3 months > 0.7, or if ABPI > 1.4, big toe pressure > 60 mmHg or alternative test confirming normal blood flow
For venous leg ulcers: Willing to comply with compression therapy

You will not qualify if you...

Infected ulcer requiring systemic antibiotic therapy at enrollment
Circumferential wound
Known allergy or hypersensitivity to dressing materials
Participation in the DIPLO NBF study
Use of wound fillers

Research Team

Janet Kandrevas, MD, MS

Andrea Picchietti, MS, CCRA

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