Dose-response relationship study of S42909 on leg ulcer healing after oral repeated administration in patients with active venous leg ulcer. A 10-week randomized, double-blind, placebo-controlled, prospective, international, multicentre, phase IIa study.

Ilkos Thérapeutique Inc.0 个研究点目标入组 204 人开始时间: 2017年5月3日最近更新: 2020年5月11日

试验速览

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•- Caucasian, men or women
•- Age = 18 years old.
•- 18.5 kg/m2 = BMI = 45.0 kg/m2 (= Weight (kg) / height² (m²)).
•- Patients with chronic venous disease documented by imaging to detect a venous disorder in the sub- and extra-fascial venous system. The examination performed within 6 months before selection can be used.
•- Patients with at least one active venous leg ulcer localised in the gaiter area (CEAP C6) diagnosed or reoccurred for more than 6 weeks and less than 2 years at selection and 3 cm away from other ulcers. Patients with bilateral ulcerations or multiple ulcerations on one or both legs are eligible for selection.
•- Size of Reference Ulcer (defined as the largest ulcer in size that is fitting the area selection criteria) should be = 5 cm2 and = 100 cm2 (measured by transparent sheet and confirmed with the digital 3D imaging device).
•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 102
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 102

•- Unlikely or unwilling to be compliant to standardized compression recommendation, study medication and visits, previous records of poor compliance to compression stockings.

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