NCT06847750

Elastography Ultrasound in Localized Scleroderma (Morphea) Study

Elastography Ultrasound in Localized Scleroderma (Morphea): a Prospective, Longitudinal, Multicentric Pilot Study

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Localized scleroderma (LS) is a skin disease that can cause complications such as disfigurement and limitation of mobility. Treatment for LS should be initiated early in the disease, as late-stage scleroderma does not respond well to treatment. Objective tools for diagnosis and follow-up of treatment for LS are not available clinically and are urgently needed. A new non-invasive ultrasound technique called "elastography" measures stiffness of tissues and holds potential for providing objective measures for follow-up of treatment of LS in children and adolescents. The team plans to conduct a multicenter study in North America to determine whether elastography ultrasound can show changes in skin stiffness for a period of 9 to 12 months after initiation of treatment for LS. This novel technology may add information to the existing imperfect clinical tools, thus improving the way therapy is offered to patients with LS.

Conditions

• Scleroderma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Elastography Ultrasound	The US imaging protocol will include three parts: (i) gray-scale; (ii) color Doppler, and (iii) Shear-wave elastography (SWE)
OTHER	The Localized Scleroderma Quality of Life Instrument (LoSQI )	The questionnaire is a validated disease-specific patient-reported outcome measure that covers different domains (skin sensations, physical functioning, body image and social support, designed for children and adolescents with localized scleroderma

Timeline

• Start date: 2023-03-10
• Primary completion: 2026-03-30
• Completion: 2026-12-31
• First posted: 2025-02-26
• Last updated: 2025-02-26

Locations

1 site across 1 country: Canada