Hand Disability In Systemic Sclerosis - Digital Ulcers

March 17, 2026 updated by: Zülal TATAR, Pamukkale University

Investigation of the Turkish Validity and Reliability of Hand Disability In Systemic Sclerosis - Digital Ulcersthe (HDISS-DU) Questionnaire in Individuals With Systemic Sclerosis

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.

Study Overview

Status

Enrolling by invitation

Conditions

Study Type

Observational

Enrollment (Estimated)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Malatya
      • Denizli, Malatya, Turkey (Türkiye)
        • Pamukkale University
      • Malatya, Malatya, Turkey (Türkiye)
        • Inonu University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Hand Disability in Systemic Sclerosis-Digital Ulcers Questionnaire
Time Frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scleroderma Health Assessment Questionnaire
Time Frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Used to assess disease activity. It has 20 items in 8 sections assessing physical disability. In addition, Raynaud phenomenon, digital ulcers, pulmonary and gastrointestinal symptoms are assessed according to the Visual Analog Scale, which is scored between "0" and "10". VAS is scored between 0 and 3 by multiplying by 0.2
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
Time Frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
The scle assesses activity and participation in patients with systemic sclerosis. It consists of 17 items and two sections: Section A (10 items, factor 1) assesses mobility. Section B (7 items, factor 2) assesses general tasks and demands. The score for each section is the sum of the scores for each item: Section A scores range from 0 to 100, and Section B scores range from 0 to 70. The total score for the Cochin 17-Item Scleroderma Functional Scale is defined as the sum of the scores for each section and ranges from 0 (no limitation) to 170 (maximum limitation).
Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pamukkale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2024

Primary Completion (Estimated)

September 24, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

October 24, 2024

First Submitted That Met QC Criteria

October 24, 2024

First Posted (Actual)

October 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSc Validity and Reliability

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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