NCT05588583 A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing.
| NCT ID | NCT05588583 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Molnlycke Health Care AB |
| Condition | Wounds |
| Study Type | INTERVENTIONAL |
| Enrollment | 68 participants |
| Start Date | 2022-10-31 |
| Primary Completion | 2024-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 68 participants in total. It began in 2022-10-31 with a primary completion date of 2024-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to follow the progress of wounds in those with venous leg ulcers and diabetic foot ulcers while using an absorbent dressing called Mepilex Up. The main objective is to follow the progress of these wounds over time from initial visit to each follow-up visit. Participants will be asked to wear Mepilex Up dressing for up to 6 weeks of treatment or until healed, changed at every one-week interval.
Eligibility 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
Contact & Investigator
Hadar Lev-Tov, MD, MAS
PRINCIPAL INVESTIGATOR
University of Miami
Frequently Asked Questions
Who can join the NCT05588583 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Wounds. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05588583 currently recruiting?
Yes, NCT05588583 is actively recruiting participants. Contact the research team at janet.kandrevas@molnlycke.com for enrollment information.
Where is the NCT05588583 trial being conducted?
This trial is being conducted at Castro Valley, United States, Los Angeles, United States, Miami, United States, Pittsburgh, United States.
Who is sponsoring the NCT05588583 clinical trial?
NCT05588583 is sponsored by Molnlycke Health Care AB. The principal investigator is Hadar Lev-Tov, MD, MAS at University of Miami. The trial plans to enroll 68 participants.