Systemic Sclerosis (SSc)NCT06658470
Hand Disability In Systemic Sclerosis - Digital Ulcers
An observational study of Systemic Sclerosis (SSc) and Digital Ulcer, run by Pamukkale University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis (SSc), Digital Ulcer
- How many people
- 72 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 24 Oct 2024to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Diagnosed with SSc by a rheumatologist
- Being 18 years of age or older
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites
Pamukkale University
Denizli, Malatya
Inonu University
Malatya, Malatya
About this study
Official title: 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.
- Conditions
- Systemic Sclerosis (SSc), Digital Ulcer
- Medical subject headings
- Scleroderma, Systemic, digital ulcers
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: 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
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).
Measured: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start24 Oct 2024
- Primary completion24 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Sclerosis (SSc)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zülal TATAR, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658470
- Sponsor's protocol ID
- SSc Validity and Reliability
- Status last verified
- Mar 2026
- First submitted
- 24 Oct 2024
- Last updated
- 19 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Turkish Validity and Reliability of Hand Disability In Systemic Sclerosis - Digital Ulcersthe (HDISS-DU) Questionnaire in Individuals With Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT06658470
- Acronym / sponsor ID
- SSc Validity and Reliability
- Conditions
- Systemic Sclerosis (SSc), Digital Ulcer
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- 24 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Diagnosed with SSc by a rheumatologist
- Being 18 years of age or older
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
Related trials for Systemic Sclerosis (SSc)
RecruitingPhase 1
A Safety and Efficacy Study Evaluating CTX112 in Adult Subjects With Refractory Autoimmune Disease
SLE (Systemic Lupus), Lupus Erythematosus, Systemic
RecruitingObservational study
Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies
Chronic Obstructive Pulmonary Disease (COPD), Smoking
RecruitingPhase 1
A Clinical Study of YTS109 Cell in R/R Autoimmune Diseases
Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc)
RecruitingPhase 1
A Clinical Study of YTS109 Cell for R/R Autoimmune Diseases
Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN)
Not yet recruitingPhase 2
Mycophenolate After Stem Cell Transplant for Systemic Sclerosis
Systemic Sclerosis (SSc)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Sclerosis (SSc) and Digital Ulcer, run by Pamukkale University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.