A Multicentre European Study to Evaluate Granulox® Used in the Treatment Pathway of Predominantly Chronic Venous Leg Ulcers (VLUs). — Granulox01  

Venous Leg Ulcer Clinical Trial

Official title: Multicentre, Prospective, Randomized, Open-label, Assessor Blinded Study to Evaluate Granulox® Used as Adjunct Therapy to Defined Standard of Care vs. Defined Standard of Care for the Treatment of Predominantly Chronic Venous Leg Ulcers (VLUs)

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

The current study is designed to verify previous clinical findings and to pinpoint clinically relevant efficacy, associated to intended use of Granulox® as a therapy added to a defined standard of care in the management of chronic VLUs. The most relevant outcome is considered to be an increase in healing of chronic VLUs over a period of 20 weeks.

This is a multi-centre European open label randomised 2-arm parallel group study. The study will include multiple European counties (e.g. France, Germany, UK, Poland, Croatia and Czech Republic), with approximately 2-7 clinics per country.

The study will run with a two-phase set-up, with a 14 days run-in period and a an up to 20 weeks treatment period starting with randomization and allocation of treatment. Confirmation of wound closure is further assessed after a 15 day followup period.

The primary objective of the study is to compare wound healing between management of chronic VLUs with or without added Granulox®. The main efficacy criterion is Confirmed Complete wound Closure (CCC).

Secondary objectives include comparisons of management of chronic VLUs with or without added Granulox® with regards to:

• Wound healing by means of Possible Complete wound Closure (PCC), Wound Area Regression (WAR), time to healing, trajectories, pressure ulcer scale for healing (PUSH) score, and clinical assessment.

• Patient Reported Outcomes (PRO) for health-related quality of life (HRQoL)/quality of life (QoL), pain and pain intensity, and impression of change.

• Acceptability of and compliance to therapy.

• Cost-effectiveness.

• Safety by means of Adverse Events (AE) and Serious Adverse Events (SAE) reporting. ;

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

• NCT number: NCT04181320
• Study type: Interventional
• Source: Molnlycke Health Care AB
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 8, 2020
• Completion date: December 30, 2023