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

Molnlycke Health Care AB · NCT05588583

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
68
US sites recruiting
4
Study start
October 31, 2022
Record last updated
April 20, 2023

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Mepilex Up

Conditions: Wounds; Wound of Skin; Wound Leg; Wound; Foot; Diabetic Foot Ulcer; Venous Leg Ulcer

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Center for Clinical Research, Inc.

    Castro Valley, CA 94546

    Site contact: Gayana Sarkisova, CCRC · 800-363-1069 · gayana@ccr-trials.com

  • Felix Sigal, DPM

    Los Angeles, CA 90010

    Site contact: Maira Jackson, MA · maira@lafootpain.com

  • University of Miami

    Miami, FL 33125

    Site contact: Aliette Espinosa · 305-689-3376 · a.espinosa2@med.miami.edu

  • Serena Group Research Institute

    Pittsburgh, PA 15222

    Site contact: Laura Serena · 412-335-0764 · lserena@serenagroups.com

Study contacts (from the official record)

  • Janet Kandrevas, MD, MS · 734-358-2174 · janet.kandrevas@molnlycke.com
  • Andrea Picchietti, MS, CCRA · 260-258-3879 · andrea.picchietti@molnlycke.com
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A Clinical Investigation to Follow the Progress of Exuding Chronic… (NCT05588583) | Bored Studies