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OpenTrials
Completed

NCT Number: NCT01683500

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

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

Completed

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Key information

Conditions

Calcinosis Cutis in Connective Tissue Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital Zurich, Division of Rheumatology

Zurich, Canton of Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

shock wave therapy with Modulith SLK (Storz)

Device

Three sessions with shock wave therapy, interval of one week.

Primary outcomes

  1. change in pain

    Time frame: after 6 weeks

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 11, 2012
Registry last updated
Jun 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.