Recruiting

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

Sponsor:

Molnlycke Health Care AB

Code:

NCT05588583

Conditions

Wounds

Wound of Skin

Wound Leg

Wound; Foot

Diabetic Foot Ulcer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mepilex Up

Study Details

Brief 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

Study ID

NCT05588583

Start date

Oct 31, 2022

Status verified date

Oct, 2022

Completion date

Mar, 2024

Anticipated

Primary completion date

Mar, 2024

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Signed consent to participate (including consent for digital imaging)
Adult aged ≥18 years
Diagnosed with a chronic, exuding VLU or DFU
Exudate amount moderate to large
Wound size from 3 cm2 to 30 cm2 for VLU and ≥1 cm2 for DFU, as determined by the clinician
For VLU: ABPI (within 3 months) > 0.7. If ABPI > 1.4, then big toe pressure > 60 mmHg is required or an alternative measurement verifying normal distal arterial flow
For VLU: Willing to be compliant with compression therapy

Exclusion Criteria:

Infected ulcer according to the judgment of the investigator defined as any wound condition requiring the prescription or continuation of systemic antibiotic therapy at enrollment
Circumferential wound
Known allergy/hypersensitivity to the materials of the dressing
Patients participating in the DIPLO NBF study
Use of wound fillers

Study Design

Enrollment

68 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Supportive Care with Mepilex Up

All Subjects will use a soft, silicone, non-bordered, adhesive, foam dressing called Mepilex Up as the absorbent primary dressing.

Interventions

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

Primary outcome measure

Wound progress of the total effect of treatment using Mepilex Up [ Time Frame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first. ]

Central Contacts and Locations

Central contacts

Janet Kandrevas, MD, MS

734-358-2174 janet.kandrevas@molnlycke.com

Andrea Picchietti, MS, CCRA

260-258-3879 andrea.picchietti@molnlycke.com

Locations

Center for Clinical Research, Inc.

Recruiting

Castro Valley, California, United States, 94546

Contacts

Gayana Sarkisova, CCRC

800-363-1069 gayana@ccr-trials.com

Principal Investigator:

Alexander Reyzelman, DPM

Felix Sigal, DPM

Recruiting

Los Angeles, California, United States, 90010

Contacts

Maira Jackson, MA

maira@lafootpain.com

Principal Investigator:

Felix Sigal, DPM

University of Miami

Recruiting

Miami, Florida, United States, 33125

Contacts

Aliette Espinosa

305-689-3376 a.espinosa2@med.miami.edu

Principal Investigator:

Hadar Lev-Tov, MD

Serena Group Research Institute

Recruiting

Pittsburgh, Pennsylvania, United States, 15222

Contacts

Laura Serena

412-335-0764 lserena@serenagroups.com

Principal Investigator:

Thomas Serena, MD

More Information

Sponsor

Molnlycke Health Care AB

Last update posted

Apr 20, 2023

Last verified

Oct, 2022

Keywords

Diabetic Foot Ulcer
Venous Leg Ulcer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Molnlycke Health Care AB on 2023-04-20.