Hand Disability In Systemic Sclerosis - Digital Ulcers

NCT06658470 | Enrolling By Invitation

• 1 other identifier: SSc Validity and Reliability
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study was to examine the Turkish validity and reliability of the Hand Disability in Systemic Sclerosis - Digital Ulcers Questionnaire (HDISS-DU) in individuals with Systemic Sclerosis.

Conditions

Systemic Sclerosis (SSc); Digital Ulcer

Outcome Measures

Primary Outcomes (1)

• The Hand Disability in Systemic Sclerosis-Digital Ulcers Questionnaire

  It was developed to evaluate the disability caused by digital ulcers in the hand in patients with Systemic Sclerosis. It consists of 24 questions. There are 8 response options. Responses are scored from 1 to 6. 1 'yes, without difficulty'; 2 'yes, with very little difficulty', 3 'yes, with some difficulty', 4 'yes, with great difficulty', 5 'almost impossible' and 'using only the unaffected hand' (same score for both responses) and 6 'impossible'. The eighth response option 'did not do this activity in the last 7 days' is not included in the scoring. The total HDISS-DU score is calculated as the average of the scores of the questions where the eighth option was not given as an answer (threshold for questions with an eighth answer \<12 questions). The total score ranges from a minimum of 1 point to a maximum of 6 points.

  Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

Secondary Outcomes (2)

• Scleroderma Health Assessment Questionnaire

  Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

• Cochin 17-Item Scleroderma Functional Scale

  Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will include individuals aged 18 and older who are receiving treatment for Systemic Sclerosis at two university hospital in Turkey, and meet the inclusion and exclusion criteria.

You may qualify if:

• Diagnosed with SSc by a rheumatologist
• Being 18 years of age or older

You may not qualify if:

• Presence of neurological disease
• Presence of any orthopedic problem that would affect functionality
• Presence of a history of orthopedic surgery
• Inability to speak or understand Turkish fluently
• Presence of a psychiatric disease that would affect cooperation
• Severe neurological disease that would affect hand functions (peripheral nerve lesion, trauma, operation, cerebrovascular accident)
• Heart failure and lung pathology that would affect daily living activities

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (2)

Pamukkale University

Denizli, Malatya, Turkey (Türkiye)

Location

Inonu University

Malatya, Malatya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Scleroderma, Systemic; digital ulcers

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 26, 2024
• Study Start: October 24, 2024
• Primary Completion (Estimated): September 24, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

TU (2)