A Study Of Capillaroscopic Assessment Of Peripheral Micro-vasculature Under Research Therapies In Systemic Sclerosis

Overview

About this study

The purpose of this study is to standardize the collection of Nailfold Videocapillaroscopy (NVC) data for clinical trials and research studies involving patients with systemic sclerosis

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age ≥18 years at the time of enrollment.

  • Clinical diagnosis of systemic sclerosis (SSc) (limited or diffuse cutaneous), established by the treating clinician using standard clinical criteria.

  • Receiving or initiating an investigational therapy for systemic sclerosis, including targeted immunosuppressive, immunomodulatory, cellular, or bispecific therapies, either as part of routine care or within a parent clinical trial.

  • Eligible for nailfold video capillaroscopy (NVC), with intact nailfolds and no contraindication to imaging.

  • Ability to contribute longitudinal data, defined as availability for at least baseline assessment and one follow‑up timepoint via routine clinical care or parent trial participation.

  • Provision of informed consent, if study‑specific NVC imaging or prospective data collection is required, or eligibility under an IRB‑approved authorization/waiver when only existing data or images are used.

Exclusion Criteria:

  • Inability to obtain or interpret NVC images, including active nailfold infection, significant nailfold trauma, severe digital ulceration preventing imaging, or persistent technical limitations.

  • Absence of sufficient clinical data to support longitudinal follow‑up or outcome assessment.

  • Withdrawal of consent or lack of required authorization for use of clinical data or images.

  • Concurrent conditions that, in the judgment of the investigator, would preclude meaningful participation, data interpretation, or safe completion of study‑specific procedures (e.g., inability to tolerate brief NVC imaging).

  • Enrollment in a conflicting study that explicitly prohibits use of images or data for ancillary research.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 07/28/2026. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Vivek Nagaraja, M.B.B.S., M.D.

Contact us for the latest status

Contact information:

Bianca Montelongo

4803014665

montelongo.bianca@mayo.edu

More information

Publications

Publications are currently not available