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
Molnlycke Health Care AB
20 participants
Nov 8, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- 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 Criteria4
- 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
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Interventions
ALLEVYN Non-Adhesive combines patient comfort with the tri-layer fluid management system that enables moist wound healing. It utilizes a unique triple action technology that manages fluid to maintain optimal moist wound healing conditions. It is ideal for fragile and sensitive skin due to its non-adherent wound contact layer and soft and conformable construction. ALLEVYN Non-Adhesive consists of the following layers: * Breathable top film * Highly absorbent foam core * Non-adhesive wound contact layer
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT05608317