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A Clinical Investigation to Follow the Progress of Exuding Chronic Venous Leg Ulcers Using a Non-Bordered Foam Dressing
A Prospective, Open, Multi-Center, Interventional, Non-Comparative Clinical Investigation to Follow the Progress of Exuding Venous Leg Ulcers Using a Non-Bordered Foam Dressing
Who can join
Ages 18 and older · All sexes
Full 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
About the study
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.
What is being tested
- ALLEVYN Non-Adhesive (device)
Sponsor: Molnlycke Health Care AB · Participants: 20 · Started: Nov 8, 2022
Contact the study team
- Janet Kandrevas, MD, MS · Phone: 734-358-2174
- Andrea Picchietti, MS, CCRA · Phone: 260-258-3879
Official record on ClinicalTrials.gov — NCT05608317
Locations in the U.S.
| California | Center for Clinical Trials, Inc., San Francisco (Not yet recruiting) |
| Florida | University of Miami, Miami |
| Pennsylvania | Serena Group Research Institute, Pittsburgh |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.