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

Launched by MOLNLYCKE HEALTH CARE AB · Nov 1, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the healing process of chronic venous leg ulcers, which are wounds that don’t heal properly and often leak fluid. The researchers want to see how well a special type of foam dressing without borders helps these wounds heal over time. Participants in the study will need to wear this dressing for up to six weeks or until their wound is healed, with the dressing being changed every week.

To join the trial, participants need to be adults aged 18 or older who have been diagnosed with a chronic venous leg ulcer that has a moderate to large amount of fluid and falls within a specific size range. It's important that their blood flow to the legs is adequate and that they are willing to follow additional treatment guidelines, like wearing compression bandages. Those with infected wounds, certain types of wounds, or allergies to the dressing materials cannot participate. Throughout the trial, participants will have regular check-ups to monitor their wound's progress, and they can expect support from the healthcare team during the process.

Gender

ALL

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