Pilot Study of Description of Cicatrisation Rates of Digital Ulcers in Systemic Scleroderma

Recruiting

• Conditions: Scleroderma, Systemic

• Registration Number: NCT04319120
• Lead Sponsor: University Hospital, Limoges

Brief Summary

To make an updated inventory of digital ulcer care protocols in scleroderma patients and to specify the French data on monthly healing rates and local care with patients in care centers experience, and thus to know the impact of ulcers in different dimensions To evaluate the rate of healed digital ulcers at the end of the study

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-20
• Study First Submitted QC: 2020-03-20
• Study First Posted: 2020-03-24
• Study Start: 2020-12-17
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-04
• Last Update Posted: 2023-05-06
• Primary Completion: 2025-12
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

• Patient with systemic scleroderma according to the ACR / EULAR 2012 criteria
• Patient with one or more active digital ulcers
• Patient with internet access and camera or smartphone

Exclusion Criteria

• Minor patients
• Patient deprived of liberty or subject to a court order
• Patient subject to a legal protection measure
• Pregnant or lactating woman
• Patient unable to complete the questionnaires

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of digital ulcers	1 year	Number of digital ulcers healed at the end of the study

Trial Locations

Locations (3)

Bordeaux Hospital; 🇫🇷 Bordeaux, France

Limoges Hospital; 🇫🇷 Limoges, France

Toulouse Hospital; 🇫🇷 Toulouse, France