Tracking the healing of chronic wounds with a special 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 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.

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 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 it's running

• 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

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

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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.