A Clinical Study of Tranilast in the Treatment of Scleredema Diabeticorum

Early Phase 1

• Conditions: Scleredema Adultorum
• Interventions: Drug: Tranilast

• Registration Number: NCT03512873
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2018-01
• Study First Submitted: 2018-04-19
• Study First Submitted QC: 2018-04-19
• Last Update Submitted: 2018-04-19
• Study First Posted: 2018-05-01
• Last Update Posted: 2018-05-01
• Study Start: 2018-06
• Primary Completion: 2020-06
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 56

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

• (1)with a liver or kidney disease, or accompanied by a tumor or a severe infection ; (2)Poor blood sugar control; (3)with mental disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tranilast	Tranilast	-

Primary Outcome Measures

Name	Time	Method
Measure the volume change of skin lesions by ultrasound	This experiment will last for 6 months	During tranilast (0.1g each time, three times a day, 6 months) treatment, patients need to test lesion volume.The reduction of volume greater than 50% is judged to be effective