A confirmatory multicentre, multinational, prospective, parallel-group, randomized, double-blind clinical investigation of the performance and safety of Ialuset® cream versus neutral comparator cream in the treatment of chronic, venous or mixed origin leg ulcer

IBSA Institut Biochimique (Switzerland)0 sites170 target enrollmentNovember 23, 2020

Overview

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/35025757 (added 14/03/2022)

Registry

who.int

Start Date

November 23, 2020

End Date

July 18, 2020

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Sponsor

IBSA Institut Biochimique (Switzerland)

•1\. Adult male and female (aged \=18 years)
•2\. Subject diagnosed with a leg ulcer \>2 months and \<4 years duration
•3\. Subject diagnosed with one or several leg ulcers of mere venous (varicose or post\-thrombotic) origin, or of mixed venous and arterial origin with predominance of venous aetiology
•4\. Presence of an ulcer that was intended to be treated with a surface area \=5 cm² and \=40 cm²
•5\. Subject having undergone an arterial\-venous Doppler examination within 6 months prior to inclusion, showing a superficial or profound reflux in the venous system, and/or a well\-documented past history of deep venous thrombosis of the lower limbs, and/or clinical evidence of post\-thrombotic syndrome with chronic oedema and lipodermatosclerosis
•Ankle/brachial Doppler systolic pressure index \=0\.8 and \=1\.2 within 6 months prior to inclusion
•6\. Patient whose leg ulcer compression system was adapted and worn during the study
•7\. Subject having an albuminemia \=25 g/l (measured \=2 weeks prior to inclusion)
•8\. Female subjects of childbearing potential having a negative urine pregnancy test result at screening and at the randomisation visit, and practising two reliable methods of contraception throughout the study
•9\. Subject having a satisfactorily general condition and a life expectancy longer than the duration of the study, according to the Investigator

•1\. Subject with an ulcer of non\-venous origin (e.g., phagedenic pyodermatitis, pyoderma gangrenosum, neoplastic or infectious origin) or related to a general cause (e.g., haematological cause).
•2\. Presence of necrotic tissue \=50% of the target ulcer surface area
•3\. Subject with clinical evidence of a significant arterial insufficiency (claudication, pain of decubitus ulcers), and/or Ankle\-Brachial Pressure Index (ABPI) \<0\.8 or \>1\.2
•4\. Subject with any type of diabetes mellitus, as per medical records (i.e. glycated haemoglobin – HbA1c \<6\.5%) or investigator judgment. (Note: HbA1c \<6\.5% was a typographical error and the investigators were told to interpret that as HbA1c \>6\.5%. This error was present in CIP v1\.0, 24Feb2017, CRF v3\.0, 11Aug2017\)
•5\. Subject suffering from severe hepatic disorders (with serum activity of ALT/AST \=2\.5 UNL)
•or severe renal disorders (creatinine clearance \<30 ml/min) identified within 3 months prior to inclusion
•6\. Subject with a clinical suspicion of wound infection (e.g., erysipelas, phlegmon) based on the presence of at least one of the following symptoms: peri\-ulcerous inflammation, odorous and purulent flow, adenopathy, lymphangitis, fever, unexpected healing interruption, or abscess.
•7\. Ulcer with exposed tendon or bone
•8\. Ulcer due to local or extended malignancy
•9\. An episode of acute deep vein thrombosis (DVT) within 3 months prior to inclusion