Treatment of chronic, venous or mixed origin leg ulcer Circulatory System
Conditions
Interventions
Eligible particpants are randomly allocated to Ialuset® cream or a neutral comparator in a ratio of 1:1 using a centralized randomisation system. Target ulcer size (target ulcer size =20 cm² or >20 cm
Sponsors
IBSA Institut Biochimique (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 10. Having signed a written informed consent to participate in the study, according to GCP 11. For France: subjects covered by a health insurance system/policy
Exclusion criteria
Exclusion criteria: 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) 1.2 4. Subject with any type of diabetes mellitus, as per medical records (i.e. glycated haemoglobin – 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 10. Subject under treatment with drugs known to adversely affect the healing process: i.e., systemic corticosteroids, cytostatic drugs, immunosuppressive agents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion (%) of subjects with completely healed target ulcer (defined as 100% reepithelialisation of the wound area based on standardised photographs of the target ulcer), as observed at Study Visit 6, or at any earliest study visit and further confirmed at a follow-up visit 3 weeks post last treatment, centrally assessed on standardized pictures | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of patients with complete ulcer healing at 20 weeks and confirmed 3 weeks later, assessed by PI 2. Percentage of patients with complete ulcer healing at 4, 8, 12, 16, 20 and 23 weeks, centrally assessed 3. Target ulcer residual area (% relative) to baseline, centrally assessed at 4, 8, 12, 16, 20 and 23 weeks 4. Condition of the peri-ulcerous skin assessed by PI at 4, 8, 12, 16, 20 and 23 weeks 5. Total amount (doses) of analgesics consumed collected by the PI at 4, 8, 12, 16, 20 and 23 weeks 6. Percentage of subjects with infection of the target ulcer recorded by the PI after the start of IMD application 7. Compliance to the treatment assessed as the % IMD daily application counted from the returned IMD 8. Time to complete healing as centrally assessed calculated using percentage of complete healing over time 9. Pain measured using VAS score at 4, 8, 12, 16, 20 and 23 weeks 10. Safety outcomes measured using AEs, SAEs described by MeDRA system organ classes, frequency of AEs/SAEs and percentage of patients experiencing AEs/SAEs at 4, 8, 12, 16, 20 and 23 weeks | — |
Countries
France, Poland
Outcome results
None listed