Tracking the healing of chronic venous leg ulcers with a special foam dressing

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical investigation aims to monitor the healing process of chronic venous leg ulcers (VLUs) using a non-bordered foam dressing over a period of up to six weeks. Participants will wear the dressing, which will be changed weekly, while their wound progress is assessed through objective measurements and subjective evaluations of pain, comfort, and quality of life. The study will involve multiple visits to the investigation site to ensure thorough monitoring and safety assessments. A total of 20 participants will be recruited across six centers in the US and Canada.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Miami
  Miami, Florida, United States Recruiting
• Serena Group Research Institute
  Pittsburgh, Pennsylvania, United States Recruiting
• Center for Clinical Trials, Inc.
  San Francisco, California, United States Not yet recruiting

Study contacts

• Principal investigator: Hadar Lev-Tov, MD, MAS — University of Miami
• Study coordinator: Janet Kandrevas, MD, MS
• Email: janet.kandrevas@molnlycke.com
• Phone: 734-358-2174

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Human placental membrane products plus standard care for nonhealing diabetic foot and venous leg ulcers

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.