Efficacy and safety of a hyaluronic acid-containing cream in the treatment of chronic, venous, or mixed-origin leg ulcers: a prospective, multicenter, randomized, controlled trial

Not Applicable

Completed

• Conditions: Treatment of chronic, venous or mixed origin leg ulcer; Circulatory System

• Registration Number: ISRCTN15487707
• Lead Sponsor: IBSA Institut Biochimique (Switzerland)

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-07-18
• Study Start: 2020-11-23
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 170

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

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
10. Subject under treatment with drugs known to adversely affect the healing process: i.e., systemic corticosteroids, cytostatic drugs, immunosuppressive agents

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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