Tracking the healing of chronic venous leg ulcers with a special 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
This study is testing a special foam dressing to see if it helps people with chronic venous leg ulcers heal better over six weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Molnlycke Health Care AB Industry-sponsored |
| Locations | 3 sites (San Francisco, California and 2 other locations) |
| Trial ID | NCT05608317 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with chronic, exuding venous leg ulcers that meet specific size and exudate criteria.
Not a fit: Patients with infected ulcers or known allergies to the dressing materials may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve healing outcomes for patients with chronic venous leg ulcers.
How similar studies have performed: While similar approaches have been explored, this specific investigation focuses on a novel dressing type for chronic venous leg ulcers.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Francisco, California and 2 other locations
- Center for Clinical Trials, Inc. — San Francisco, California, United States (Not_yet_recruiting)
- University of Miami — Miami, Florida, United States (Recruiting)
- Serena Group Research Institute — Pittsburgh, Pennsylvania, United States (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.