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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
128
Granulox will be added as an adjunct therapy to defined standard of care in subjects with predominantly venous leg ulcers.
Klinicki odjel za vaskularnu kirurgiju
Split, Croatia
University Hospital Dubrava
Zagreb, Croatia
Zavod za vaskularnu kirurgiju
Zagreb, Croatia
Salvatella s.r.o.
Třinec, Dolni Lomna, Czechia
CHIR-Chirurgické oddeleni
Jihlava, Czechia
U Nemocnice v Praze
Prague, Czechia
Hopital Michallon
Grenoble, La Tronche, France
Hopital Nord Franche-Comte
Belfort, Trevenans, France
Hopital Rothschild - AP-HP
Paris, Île-de-France Region, France
Department od Dermatology, Venerology and Allergology, University of Essen
Essen, North Rhine-Westphalia, Germany
...and 17 more locations
Confirmed Complete Wound Closure
Confirmed Complete wound Closure is defined as an blinded assessment and observation of 100% re-epithelialization, confirmed by a second visit 15 days later (+/- 3 days).
Time frame: Up to 20 weeks post therapy initiation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.