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Low Energy Shockwave Therapy (LE-SWT): A Novel Treatment for Chronic Kidney Disease

NCT02515461 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-03-06

No results posted yet for this study

Summary

The investigators aim to investigate whether low energy shockwave therapy (LE-SWT) can preserve kidney function in diabetic patients. Participants in this study will receive LE-SWT treatment 6 times over 3 weeks. The treatment is non-invasive and has no known side effects. Previous studies have shown that LE-SWT induces angiogenesis. The investigators hypothesize that chromium-ethylenediaminetetraacetic acid (EDTA) renal clearance remains stable or increases in treated patients. Furthermore, kidney biopsy should show no signs of damage to the tissue and possibly neo-vascularization. In this project, the investigators shall also investigate LE-SWT effect on urinary markers of tubular damage and urinary nitric oxide indices. Patients' self-reported quality of life will be assessed using Short Form 36 version 2 (SF-36v2) Health Survey.

There is an 18-months follow-up on patients. Only patients between 18-65 years old with moderate chronic kidney failure from diabetes will be included.

This project is an interventional prospective study. 30 patients with moderate kidney failure will be recruited from the Department of Endocrinology, Odense University Hospital, Denmark. LE-SWT treatment will be performed in the ambulatory of Department of Urology. Patients will be hospitalized for 1 day in the Department of Nephrology when kidney biopsy is taken (two times in study period).

Conditions

  • Diabetic Nephropathies

Interventions

DEVICE

Low energy shockwave therapy

Procedure: The patient lies on supine position during treatment. Kidney will be localised in line ultrasound. 3000 shockwaves at a frequency of 4 Hz are applied to each kidney per session. The kidney will be divided into three treatment areas including 1000 shockwaves applied to each treatment area. Patients will receive 6 sessions over 3 weeks. Treatments are carried out on day 1, day 3, day 7, day 10, day 14, and day 17 after enrollment (average time points). Treatment is performed using the MODULITH SLX-F2, manufactured by STORZ MEDICAL AG.

Sponsors & Collaborators

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Lars Lund, Professor · Odense University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2022-01-31
Completion
2022-01-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02515461 on ClinicalTrials.gov