What is this study trying to find out about venous leg ulcers?

This study aims to track how wounds from venous leg ulcers heal when treated with a non-bordered foam dressing. Researchers want to understand the wound's progress over time and how the dressing affects healing. The study is sponsored by Molnlycke Health Care AB and includes several centers in the US and Canada.

Who may be eligible for this venous leg ulcer clinical trial?

Adults aged 18 years or older with a chronic, leaking venous leg ulcer may be eligible. Participants must have moderate to large wound drainage, a wound size between 3 and 30 cm2, and be willing to use compression therapy. People with infected ulcers or allergies to the dressing materials cannot join. Please review eligibility criteria for more details.

Is there any cost to participate in this venous leg ulcer clinical trial?

Study-related care, including the study dressing and all trial visits, is provided at no cost. However, personal travel expenses to attend visits may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID05608317

A Prospective, Open, Multi-Center Investigation to Follow the Progress of Venous Leg Ulcers Using a Non-Bordered Foam Dressing

Led by Molnlycke Health Care AB · Updated on 2024-05-06

Participants Needed

Research Sites

17 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the progress of chronic venous leg ulcers in adults using a non-bordered foam dressing. This prospective, open, multi-center, interventional study aims to track wound healing over a 6-week period or until the wound heals. The study focuses on venous leg ulcers that produce moderate to large amounts of fluid and includes 20 participants across centers in the US and Canada. All participants will use the ALLEVYN Non-Adhesive foam dressing as the primary absorbent dressing. This device combines a breathable top film, a highly absorbent foam core, and a non-adhesive wound contact layer designed for comfort and optimal moist wound healing. The dressing will be worn continuously and changed every week during the treatment period. Participants will attend seven visits a baseline visit followed by weekly visits up to six weeks. At each visit, wound progress will be assessed by measuring wound size and evaluating wound condition. Researchers will also monitor pain, comfort, quality of life, dressing performance, and safety throughout the study. The main outcome measured is wound progress from baseline to last follow-up, with additional assessments including wound area reduction, tissue changes, exudate characteristics, skin condition, and adverse events.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Signed consent to participate, including consent for digital imaging
Adults aged 18 years or older
Diagnosed with a chronic, leaking venous leg ulcer
Moderate to large amount of wound fluid
Wound size between 3 and 30 square centimeters
Ankle Brachial Pressure Index (ABPI) greater than 0.7 within the last 3 months; if ABPI is over 1.4, a big toe pressure over 60 mmHg or alternative normal arterial flow measurement is needed
Willingness to comply with compression therapy

You will not qualify if you...

Infected ulcer requiring systemic antibiotics at enrollment
Wound that goes all the way around the limb (circumferential wound)
Known allergy or sensitivity to dressing materials
Current use of wound fillers

Research Team

Janet Kandrevas, MD, MS

Andrea Picchietti, MS, CCRA

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