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A Clinical Investigation to Follow the Progress of Exuding Chronic Venous Leg Ulcers Using a Non-Bordered Foam Dressing

Molnlycke Health Care AB · NCT05608317

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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
20
US sites recruiting
2
Study start
November 8, 2022
Record last updated
May 6, 2024

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

What the study is about

The goal of this clinical trial to follow the progress of wounds in those with chronic venous leg ulcers while using a non-bordered foam dressing. 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 the dressing for up to 6 weeks of treatment or until healed, changed at every one-week interval.

Being studied: ALLEVYN Non-Adhesive

Conditions: Wounds; Wound of Skin; Wound Leg; 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
  • Exudate amount moderate to large
  • Wound size from 3 cm2 to 30 cm2, as determined by the clinician
  • 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
  • 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
  • Use of wound fillers

Recruiting US locations

  • 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
A Clinical Investigation to Follow the Progress of Exuding Chronic… (NCT05608317) | Bored Studies