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NCT05608317
A Clinical Investigation to Follow the Progress of Exuding Chronic Venous Leg Ulcers Using a Non-Bordered Foam Dressing
Conditions: Wounds, Wound of Skin, Wound Leg, Venous Leg Ulcer
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 20
Sponsor: Molnlycke Health Care AB
Location: United States
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 yearsDiagnosed with a chronic, exuding VLUExudate amount moderate to largeWound size from 3 cm2 to 30 cm2, as determined by the clinicianABPI (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 flowWilling to be compliant with compression therapyExclusion 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 enrollmentCircumferential woundKnown allergy/hypersensitivity to the materials of the dressingPatients participating in the DIPLO01 studyUse of wound fillers
Source: ClinicalTrials.gov (NCT05608317). StuddyBuddy aggregates publicly available trial information.