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A Multicentre European Study to Evaluate Granulox® Used in the Treatment Pathway of Predominantly Chronic Venous Leg Ulcers (VLUs).

NCT04181320 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2024-11-08

Study results available
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Summary

The investigation is designed as an open label, randomized, prospective, assessor blinded, multi centre investigation.

254 evaluable subjects will be randomized to either standard of care group or standard of care with Granulox added as an adjunct therapy in predominantly venous leg ulcer subjects. Standard of care wound management will be completed, including wound cleansing, debridement if necessary and application of a suitable dressing and compression system until complete wound closure.

The study will be divided into two phases. Firstly, a two week run-in period to ensure compliance to compression therapy followed by a 20 weeks treatment period starting with randomization and allocation of treatment.

Conditions

  • Venous Leg Ulcer

Interventions

DEVICE

Venous Leg Ulcer Standard of Care with Granulox

Granulox will be added as an adjunct therapy to defined standard of care in subjects with predominantly venous leg ulcers.

Sponsors & Collaborators

  • Molnlycke Health Care AB

    lead INDUSTRY

Principal Investigators

  • Joachim Dissemond, Professor Dr. · University Hospital, Essen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-08
Primary Completion
2023-01-17
Completion
2023-01-17

Countries

  • Croatia
  • Czechia
  • France
  • Germany
  • Hungary
  • Poland
  • 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 NCT04181320 on ClinicalTrials.gov