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Calcinosis Cutis: Therapeutic Effects of Extracorporeal Shock Wave Therapy (ESWT)

This study is currently recruiting participants.
Verified September 2012 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01683500
First received: September 7, 2012
Last updated: September 12, 2012
Last verified: September 2012
History of Changes
  Purpose

Patients with calcinosis cutis due to connective tissue disease get a shock wave therapy. The shock wave therapy will be done in 3 sessions with one week interval. The outcome parameters are: change in pain, size of the calcinosis, of possible ulcers and intake of painkillers.

  • Trial with medical device

Condition Intervention Phase
Calcinosis Cutis Due to Connective Tissue Disease
 Device: shock wave therapy with Modulith SLK (Storz)
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • change in pain [ Time Frame: after 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: August 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: shock wave therapy Device: shock wave therapy with Modulith SLK (Storz)
Three sessions with shock wave therapy, interval of one week.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Age of 18
  • Calcinosis cutis due to connective tissue disease
  • information about ESWT given
  • Patient understands the study and signs the informed consent

Exclusion criteria:

  • No ESWT done
  • cuagulopathy
  • sepsis
  • pregnancy
  • pace maker
  • severe disease in the opinion of the investigator
  • cardiac risk with NYHA III-IV
  • Ehlers-Danlos-Syndrome
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01683500

Contacts
Contact: Sandra Blumhardt, MD +41 (0)44 255 11 11 sandra.blumhardt@usz.ch

Locations
Switzerland
University Hospital Zurich, Division of Rheumatology Recruiting
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Sandra Blumhardt, MD University Hospital Zurich, Division of Rheumatology
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01683500     History of Changes
Other Study ID Numbers: CCESWT01
Study First Received: September 7, 2012
Last Updated: September 12, 2012
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Calcinosis
Connective Tissue Diseases
Calcium Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on June 17, 2013