NCT07182968

Brief Summary

The Patient Self-Assessment of Skin Thickness in Upper Limb (PASTUL) questionnaire was developed to enable patients to assess skin thickness in systemic sclerosis (SSc) physically and has been validated for reliability and validity, as it correlates with the modified Rodnan Skin Score (mRSS), which rheumatologists assess. Thus, it has been demonstrated to be an applicable and easy approach for assessing skin thickness in SSc patients through patient-reported measurements. This study aimed to develop a Turkish version of the PASTUL questionnaire and to provide for its use in the Turkish population.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
15mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress38%
Aug 2025Aug 2027

Study Start

First participant enrolled

August 4, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 13, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2027

Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

2 years

First QC Date

September 13, 2025

Last Update Submit

September 13, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patient Self-Assessment of Skin Thickness in Upper Limb (PASTUL) Questionnaire

    The PASTUL survey is a simple assessment by the patient of the skin in eight areas of the upper extremities as normal, mildly, moderately, or severely thickened, corresponding to the mRSS assessment. The assessment score is consistent with the mRSS (0-3). A high score indicates increased skin thickness

    Two weeks

Secondary Outcomes (7)

  • Scleroderma Health Assessment Questionnaire (SHAQ)

    Two weeks

  • Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire (BETY-BQ)

    Two weeks

  • Short Form-36 (SF-36)

    Two weeks

  • Modified Rodnan skin score (MRSS)

    Two weeks

  • Modified Hand Mobility in Scleroderma Test (mHAMIS)

    Two weeks

  • +2 more secondary outcomes

Study Arms (1)

Systemic sclerosis

Other: Questionnaire study

Interventions

Questionnaire application

Systemic sclerosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population will consist of individuals who come to the university hospital for routine controls.

You may qualify if:

  • Individuals diagnosed with scleroderma,
  • Individuals aged 18 years and older

You may not qualify if:

  • Advanced heart/lung/liver/kidney disease, neurological disease, and malignancies
  • Individuals who are unwilling to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Çankaya, Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Scleroderma, SystemicScleroderma, Diffuse

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Central Study Contacts

Orkun Tüfekçi, PT, PhD(c)

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, PT, PhD(c)

Study Record Dates

First Submitted

September 13, 2025

First Posted

September 19, 2025

Study Start

August 4, 2025

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 4, 2027

Last Updated

September 19, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations