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

NCT05588583 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2023-04-20

No results posted yet for this study

Summary

The goal of this clinical trial is to follow the progress of wounds in those with venous leg ulcers and diabetic foot ulcers while using an absorbent dressing called Mepilex Up. The main objective is to follow the progress of these wounds over time from initial visit to each follow-up visit.

Participants will be asked to wear Mepilex Up dressing for up to 6 weeks of treatment or until healed, changed at every one-week interval.

Conditions

  • Wounds
  • Wound of Skin
  • Wound Leg
  • Wound; Foot
  • Diabetic Foot Ulcer
  • Venous Leg Ulcer

Interventions

DEVICE

Mepilex Up

Mepilex Up is a highly conformable dressing that absorbs both low and high viscous exudates, maintains a moist wound environment and minimises the risk of maceration. The dressing has a Safetac® wound contact layer that is a unique adhesive technology. It minimises pain to patients and trauma to wounds and the surrounding skin at dressing removal. Mepilex Up consists of: * a soft silicone wound contact layer (Safetac) * a flexible absorbent pad of compressed polyurethane foam * an outer polyurethane film which is breathable but waterproof Dressing material content: Silicone, polyurethane

Sponsors & Collaborators

  • Molnlycke Health Care AB

    lead INDUSTRY

Principal Investigators

  • Hadar Lev-Tov, MD, MAS · University of Miami

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-31
Primary Completion
2024-03-31
Completion
2024-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05588583 on ClinicalTrials.gov