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

Last updated: May 3, 2024
Sponsor: Molnlycke Health Care AB
Overall Status: Active - Recruiting

Phase

N/A

Condition

Venous Leg Ulcers

Wounds

Ulcers

Treatment

ALLEVYN Non-Adhesive

Clinical Study ID

NCT05608317
DIPLO NBF
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 isrequired or an alternative measurement verifying normal distal arterial flow
  • Willing to be compliant with compression therapy

Exclusion

Exclusion Criteria:

  • Infected ulcer according to the judgment of the investigator defined as any woundcondition requiring the prescription or continuation of systemic antibiotic therapy atenrollment
  • Circumferential wound
  • Known allergy/hypersensitivity to the materials of the dressing
  • Use of wound fillers

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: ALLEVYN Non-Adhesive
Phase:
Study Start date:
November 08, 2022
Estimated Completion Date:
November 30, 2024

Study Description

This investigation is designed as a prospective, open, multi-center, interventional, non-comparative investigation with the aim to follow chronic wound progression for 6 weeks according to local standard of care. Wound progress is a summary endpoint of the total effect of treatment using the non-bordered foam dressing as the absorbent dressing and includes the changes in an objectively measured wound area and subjectively evaluated wound condition. The only included indication is Venous Leg Ulcers (VLU). A total of n=20 participants will be recruited at up to 6 centers within the US and Canada.

There will be a total of seven (7) visits to the investigation site for participants during the treatment period: baseline, followed by weekly visits up to six (6) weeks post baseline. During visits, evaluations will be performed to assess wound progression and status, wound dressing properties, as well as Subject pain, comfort, and quality of life. Safety will be assessed at all visits. One target wound per participant will be included in this investigation.

Connect with a study center

  • Center for Clinical Trials, Inc.

    San Francisco, California 94115
    United States

    Site Not Available

  • University of Miami

    Miami, Florida 33125
    United States

    Active - Recruiting

  • Serena Group Research Institute

    Pittsburgh, Pennsylvania 15222
    United States

    Active - Recruiting

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