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Not Yet Recruiting 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05608317). StuddyBuddy aggregates publicly available trial information.