NCT05608317 A Clinical Investigation to Follow the Progress of Exuding Chronic Venous Leg Ulcers Using a Non-Bordered Foam Dressing
| NCT ID | NCT05608317 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Molnlycke Health Care AB |
| Condition | Wounds |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2022-11-08 |
| Primary Completion | 2024-07-30 |
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 20 participants in total. It began in 2022-11-08 with a primary completion date of 2024-07-30.
⚠ 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 to follow the progress of wounds in those with chronic venous leg ulcers while using a non-bordered foam dressing. 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 the 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 * 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
Contact & Investigator
Hadar Lev-Tov, MD, MAS
PRINCIPAL INVESTIGATOR
University of Miami
Frequently Asked Questions
Who can join the NCT05608317 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 NCT05608317 currently recruiting?
Yes, NCT05608317 is actively recruiting participants. Contact the research team at janet.kandrevas@molnlycke.com for enrollment information.
Where is the NCT05608317 trial being conducted?
This trial is being conducted at San Francisco, United States, Miami, United States, Pittsburgh, United States.
Who is sponsoring the NCT05608317 clinical trial?
NCT05608317 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 20 participants.