A Clinical Study of Tranilast in the Treatment of Scleredema Diabeticorum

Nanjing Medical University

Status and phase

Unknown

Early Phase 1

Conditions

Scleredema Adultorum

Treatments

Drug: Tranilast

Study type

Interventional

Funder types

Other

Identifiers

NCT03512873

MH Hou

Details and patient eligibility

About

56 patients with scleredema diabeticorum will be selected to receive treatment of tranilast. After a period of time ,we can determine the efficacy of the drug by detecting the the thickness of skin before and after treatment.

Full description

56 patients with Scleredema Diabeticorum will be selected. After the signing of the informed consent ,they will be collected the initial lesions photos,the thickness of skin lesions by ultrasound and magnetic resonance,and chemical examinations including blood routine examination, routine urine test, liver function, renal function.During tranilast (0.1g each time, three times a day,6 months) treatment, patients need regular follow-up (1 per month) including liver and kidney function, blood glucose level monitoring, and every three months to retest lesion thickness.With 3 month as a time point, they were observed for two points.After the experiment, the experimental data will be arranged and the data of the thickness change of skin lesions will be statistically processed (t test) to determine whether it is meaningful.

Enrollment

56 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

(1)Clinical and histopathological examination has been proved to be scleredema diabeticorum; (2)Ultrasound and magnetic resonance detection found that the thickest skin of the back was more than 5mm.

Exclusion criteria