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VLU Dressing Study

NCT03621592 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2025-08-26

Study results available
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Summary

The goal of the study is to investigate the effectiveness of Cutimed Sorbact (Study Device) in modifying bacterial load in venous leg ulcers (VLU).

Conditions

  • Venous Leg Ulcer

Interventions

DEVICE

Cutimed® Sorbact®

Dialkylcarbomoyl chloride based wound dressing

DEVICE

Acticoat®

Silver impregnated contact layer dressing

Sponsors & Collaborators

  • BSN Medical Inc

    collaborator INDUSTRY

  • University of Miami

    lead OTHER

Principal Investigators

  • Hadar Lev-Tov, MD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-22
Primary Completion
2023-11-01
Completion
2023-11-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03621592 on ClinicalTrials.gov