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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 24, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 24, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings