A Clinical Study of Tranilast in the Treatment of Scleredema Diabeticorum

Scleredema Adultorum Clinical Trial

Official title:

A Clinical Study of Tranilast in the Treatment of Scleredema Diabeticorum

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03512873
• Other study ID #: MH Hou
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: June 2018
• Est. completion date: December 2020

Study information

• Verified date: January 2018
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Maihua Hou, professor
• Phone: +86 13776635881
• Email: houmaihua[@]jsph.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 56
• Est. completion date: December 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Scleredema Adultorum

Intervention

Drug:
• Tranilast
Subjects will be treated with tranilast

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure the volume change of skin lesions by ultrasound	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	This experiment will last for 6 months