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A RCT Evaluating the Clinical Benefit of a Silver Dressing in the Treatment of Venous Leg Ulcers

NCT05923749 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-05-22

No results posted yet for this study

Summary

Approximately 178 patients with a venous leg ulcer will be included in the investigation evaluating wound healing. All subjects are randomized to one of two treatment arms with an intervention period of 4 weeks followed by a 8 week standard of care period.

Conditions

  • Wound Heal

Interventions

DEVICE

Biatain Ag

Biatain with silver

DEVICE

Cutimed Siltec Sorbact

comparator device

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-29
Primary Completion
2025-01-29
Completion
2025-01-29
FDA Device
Yes

Countries

  • United States
  • Denmark
  • Germany
  • United Kingdom

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 NCT05923749 on ClinicalTrials.gov