Status:

RECRUITING

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

Lead Sponsor:

Molnlycke Health Care AB

Conditions:

Wounds

Wound of Skin

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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...

Detailed 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 stand...

Eligibility 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

Key Trial Info

Start Date :

November 8 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

November 30 2024

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT05608317

Start Date

November 8 2022

End Date

November 30 2024

Last Update

May 6 2024

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Center for Clinical Trials, Inc.

San Francisco, California, United States, 94115

2

University of Miami

Miami, Florida, United States, 33125

3

Serena Group Research Institute

Pittsburgh, Pennsylvania, United States, 15222

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