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

Calcinosis Cutis in Connective Tissue Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01683500
• Other study ID #: CCESWT01
• Status: Completed
• Phase: Phase 3
• First received: September 7, 2012
• Last updated: June 2, 2015
• Start date: August 2012
• Est. completion date: August 2014

Study information

• Verified date: May 2015
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Calcinosis
• Calcinosis Cutis in Connective Tissue Disease
• Connective Tissue Diseases

Intervention

Device:
• shock wave therapy with Modulith SLK (Storz)
Three sessions with shock wave therapy, interval of one week.

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Division of Rheumatology	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in pain		after 6 weeks	No