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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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