Rheopheresis for Raynaud’s and Digital Ulcers in Systemic Sclerosis

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Brief Title

Rheopheresis for Raynaud's and Digital Ulcers in Systemic Sclerosis

Official Title

A Randomized Controlled Prospective Single-center Feasibility Study of Rheopheresis for Raynaud's Syndrome and Digital Ulcers in Systemic Sclerosis

Brief Summary

      In this feasibility study, we aim to explore therapeutic Rheopheresis (RheoP) as a novel
      treatment option for SSc-associated Raynaud's phenomenon and/or digital ulcers and compare it
      to the standard of care treatment (intravenous iloprost. RheoP has been used for RP/DU with
      some success in observational studies, nevertheless, the optimal treatment modality,
      duration, or frequency of RheoP (and PEX in general) in SSc has not been established as of
      yet.
    



Study Type

Interventional


Primary Outcome

Raynaud Condition Score (RCS)

Secondary Outcome

 Development of new digital ulcers

Condition

Systemic Sclerosis

Intervention

Rheopheresis treatment

Study Arms / Comparison Groups

 Arm 1
Description:  2 Rheopheresis treatments per week x 2, followed by 8 weeks without treatment, 8 overall treatments

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

30

Start Date

February 28, 2022

Completion Date

June 2024

Primary Completion Date

December 2023

Eligibility Criteria

        Inclusion Criteria:

          1. Adult patients fulfilling ACR/EULAR classification criteria for SSc

          2. Presence of RP with or without DU

          3. Failure of at least one standard of care treatment (CCB or iloprost) for at least
             three months

          4. RCS > 4

          5. Possibility to obtain venous access (either through a peripherally or centrally
             inserted catheter)

        Exclusion Criteria:

          1. Significant anemia (<8 g/dL)

          2. Clinically relevant hemorrhagic diathesis or coagulopathy

          3. Diabetes mellitus

          4. Serious acute or chronic kidney (eGFR<30 ml/min/1.73m2) or liver failure

          5. Hypotension with systolic blood pressure <100 mmHg

          6. Chronic viral infections (HIV, Hepatitis B, C)

          7. Epilepsia, psychosis, dementia, or other relevant neurologic condition precluding the
             conduct of plasmapheresis

          8. Malignant disease or any other condition with life expectancy <12 months

          9. Known history of alcohol or drug abuse

         10. Long-term serious tobacco abuse with documented severe vascular disease (Fontaine
             >III).

         11. Severe hyperlipoproteinemia, defined as a significant elevation of Lp(a) or LDL
             cholesterol despite standard doses of medical therapy
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Peter Korsten, Dr. med., +49-551-39-60400, [email protected]

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT05204784

Organization ID

36/7/21


Responsible Party

Sponsor-Investigator

Study Sponsor

Peter Korsten

Collaborators

 DiaMed GmbH

Study Sponsor

Peter Korsten, Dr. med., Principal Investigator, University Medical Center Göttingen


Verification Date

March 2022