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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01683500
First received: September 7, 2012
Last updated: June 2, 2015
Last verified: May 2015
  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 in 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
Official Title: Calcinosis Cutis: Therapeutic Effects of Extracorporeal Shock Wave Therapy (ESWT)

Resource links provided by NLM:


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 ]

Enrollment: 4
Study Start Date: August 2012
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: shock wave therapy
intervention: shock wave therapy with Modulith SLK (Storz)
Device: shock wave therapy with Modulith SLK (Storz)
Three sessions with shock wave therapy, interval of one week.

Detailed Description:

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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01683500

Locations
Switzerland
University Hospital Zurich, Division of Rheumatology
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: June 2, 2015
Health Authority: Switzerland: Swissmedic

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

ClinicalTrials.gov processed this record on September 02, 2015