Multicenter, randomised, open-label, parallel group, controlled study to evaluate the efficacy, tollerability and safety of BioFOAM dressing containing larve of Lucilia sericata in patients with chronic, vascular ulcers with/without evident infection versus standard treatment (idrogel. - ND
- Conditions
- Patient with venous ulcers or mixed aetiology ulcers containig necrotic tissueMedDRA version: 9.1Level: LLTClassification code 10066677Term: Chronic leg ulcer
- Registration Number
- EUCTR2008-006076-30-IT
- Lead Sponsor
- ASL 2 SAVONESE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Patients are aged 18 years or above and have a sloughy and/or necrotic leg ulcer (slough and/or necrotic tissue estimated to cover a minimum of 25% of the wound) of purely venous or mixed arterial/venous aetiology. Patients have an ulcer with an area of < 5 cm2. People with diabetes mellitus are eligible to participate provided that their blood sugar is well controlled (HbA1c equal to or less than 10%) and they have venous or mixed aetiology ulcers. People with rheumatoid arthritis are eligible to participate provided they have ulcers that are deemed to be venous in origin.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
People who: Have previously been entered into the trial Are women of child bearing potential Are pregnant or lactating women Are allergic to hydrogel dressings or any of their components Have grossly oedematous legs Patients on anti-coagulants People with diabetes mellitus whose blood sugar is not well controlled (HbA1c greater than 10%).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the clinical effectiveness of a larval therapy dressing with a standard debridement technique (hydrogel) in terms of its effect on time to debridement of leg ulcers.;Secondary Objective: None;Primary end point(s): The time to debridement of the ulcers
- Secondary Outcome Measures
Name Time Method