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

ASL 2 SAVONESE0 个研究点开始时间: 2009年4月20日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•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%).

发起方

ASL 2 SAVONESE