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

Tracking Healing Progress of Chronic Venous Leg Ulcers Using a Non-Bordered Foam Dressing A Prospective, Multi-Center Clinical Study in Adults

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

How This Trial Compares With Other Options

This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.

Factors	ALLEVYN Non-Adhesive Foam Dressing (Trial Group)	Modern Foam Dressing plus Compression (Standard Care)
What is it?	A non-bordered, non-adherent polyurethane foam dressing (ALLEVYN Non-Adhesive) used for wound management in adults with exuding chronic venous leg ulcers, applied with compression therapy.	Modern non-bordered or self-adherent foam dressings, typically with high absorbency, are recommended for wound care in chronic venous leg ulcers. Used in combination with compression therapy as routine standard of care.
Role in the trial	Investigational supportive wound dressing evaluated for fluid management, wound healing progress, pain, and effect on peri-wound skin in patients receiving compression.	Current standard-of-care for exuding venous leg ulcers, serving as the comparator for supportive wound healing and symptom management in real-world practice.
Main use	Manages moderate to high exudate, protects peri-wound skin, supports moist wound healing, and is applied under compression therapy.	Absorbs wound exudate, maintains a moist environment, prevents maceration, and is compatible with compression therapy for venous leg ulcers.
How is it applied?	Applied directly over the wound bed with gentle contact, covered by standard compression bandaging. Dressing change frequency is guided by exudate amount, up to 44 days or until healing.	Placed over the wound with the absorbent side facing the wound surface, covered with compression bandages. Dressing changes typically occur every few days or when saturated.
Evidence in published studies	Ongoing clinical investigation; results for wound healing, exudate management, and comfort are not yet established.	Supported by published studies and reviews as effective for exudate management, peri-wound protection, and compatibility with compression in chronic wounds.
Important limitations or considerations	Trial is small, single-arm, and early phase; results will be limited to short-term use and open-label design. Direct comparison with other modern dressings is not included.	Effectiveness and patient experience can vary across brands and dressing types. Published studies often use different comparator products, and individual wound characteristics affect outcomes.

Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.

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

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 6 weeks or until healed, whichever occurs first

Participants use a non-bordered foam dressing as the primary absorbent dressing for their venous leg ulcers. Wound progress and dressing performance are monitored during the treatment period.

7 visits: 1 baseline visit and 6 weekly follow-up visits