Tracking the healing of chronic wounds with a special dressing
A Prospective, Open, Multi-Center, Interventional, Non-Comparative Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up
This study is testing a special dressing called Mepilex Up to see if it helps people with chronic wounds, like venous leg ulcers and diabetic foot ulcers, heal better over six weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Molnlycke Health Care AB Industry-sponsored |
| Locations | 4 sites (Castro Valley, California and 3 other locations) |
| Trial ID | NCT05588583 on ClinicalTrials.gov |
What this trial studies
This clinical investigation aims to monitor the healing progress of chronic wounds, specifically venous leg ulcers and diabetic foot ulcers, using an absorbent dressing called Mepilex Up. Participants will wear the dressing for up to six weeks, with weekly follow-up visits to assess wound size, condition, and overall treatment effectiveness. The study will include a total of 68 participants across multiple centers in the US, focusing on the changes in wound area and subjective evaluations of pain and quality of life. Safety assessments will also be conducted at each visit.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with chronic, exuding venous leg ulcers or diabetic foot ulcers.
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 wound healing outcomes for patients with chronic ulcers.
How similar studies have performed: Other studies have shown positive outcomes using similar absorbent dressings for chronic wound management.
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 or DFU * Exudate amount moderate to large * Wound size from 3 cm2 to 30 cm2 for VLU and ≥1 cm2 for DFU, as determined by the clinician * For VLU: 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 * For VLU: 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 * Patients participating in the DIPLO NBF study * Use of wound fillers
Where this trial is running
Castro Valley, California and 3 other locations
- Center for Clinical Research, Inc. — Castro Valley, California, United States (Recruiting)
- Felix Sigal, DPM — Los Angeles, California, United States (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.