NCT05608317

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Molnlycke Health Care AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 standard of care. Wound progress is a summary endpoint of the total effect of treatment using the non-bordered foam dressing as the absorbent dressing and includes the changes in an objectively measured wound area and subjectively evaluated wound condition. The only included indication is Venous Leg Ulcers (VLU). A total of n=20 participants will be recruited at up to 6 centers within the US and Canada. There will be a total of seven (7) visits to the investigation site for participants during the treatment period: baseline, followed by weekly visits up to six (6) weeks post baseline. During visits, evaluations will be performed to assess wound progression and status, wound dressing properties, as well as Subject pain, comfort, and quality of life. Safety will be assessed at all visits. One target wound per participant will be included in this investigation.

Conditions

• Wounds
• Wound of Skin
• Wound Leg
• Venous Leg Ulcer

Interventions

Type	Name	Description
DEVICE	ALLEVYN Non-Adhesive	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

Timeline

• Start date: 2022-11-08
• Primary completion: 2024-07-30
• Completion: 2024-11-30
• First posted: 2022-11-08
• Last updated: 2024-05-06

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study