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

NCT ID: NCT01683500

Last Updated: 2015-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-08-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Calcinosis Cutis in Connective Tissue Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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shock wave therapy

intervention: shock wave therapy with Modulith SLK (Storz)

Group Type EXPERIMENTAL

shock wave therapy with Modulith SLK (Storz)

Intervention Type DEVICE

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

Interventions

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shock wave therapy with Modulith SLK (Storz)

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sandra Blumhardt, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Division of Rheumatology

Locations

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University Hospital Zurich, Division of Rheumatology

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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CCESWT01

Identifier Type: -

Identifier Source: org_study_id

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