Shockwave Therapy in Lower Limb Intermittent Calf Claudication (SLICC)

April 12, 2024 updated by: Hull University Teaching Hospitals NHS Trust

Extracorporeal Shockwave Therapy in the Treatment of Intermittent Claudication Symptoms in Peripheral Vascular Disease

Peripheral arterial disease is a common condition affecting approximately 64% of 56-77 year olds. This condition restricts bloody supply to calf muscles. Pain occurs after walking a short distance and increases in intensity until the person stops, where the pain then gradually subsides. It can be limiting or occasionally debilitating and has been shown to have considerable deleterious effects of patients quality of life. Shock wave therapy has been shown to promote new blood vessel formation and improved healing amongst other findings. This study aims to identify whether shock wave therapy that is applied to the calf muscles causes such an effect to improve the blood supply to the calf muscles, reduce pain, improve walking ability and quality of life.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study aims to compare the effects of extracorporeal shockwave therapy (ESWT) to placebo with use of a sham control group on walking distances in subjects with lower limb intermittent calf claudication. Extracorporeal shockwave therapy will be applied using the PiezoWave2 shockwave system. All applications will be in adherence to the manufacturer's instructions and provided by trained staff. The device will be targeted at the gastrocnemius muscles of the affected lower leg for several minutes at each treatment session. Participants in control group will undergo the identical process as if treatment were being given but with the shockwaves not being administered and a sham device alternatively used. Participants will have several assessments prior to and after the shockwave treatment in order to quantify the effect. Assessments will include Maximum Walking Distance (MWD), Claudication Distance (CD) and Quality of life questionnaires.

Study Type

Interventional

Enrollment (Actual)

138

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Yorkshire
      • Hull, Yorkshire, United Kingdom, HU3 2JZ
        • Academic Vascular Surgery Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with unilateral or bilateral intermittent calf claudication (stable for the last 3 months).
  • Able to give written informed consent to participate in the study
  • Age > 18
  • Able to adhere to protocol and attend all follow up appointments
  • Currently receiving "best medical therapy" - anti-platelet and statin medication

Exclusion Criteria:

  • Current malignancy
  • Allergies or intolerances of either anti-platelet medication or statin therapy
  • Pregnancy (pregnancy test performed at screening if necessary)
  • Metal implant near to treatment area
  • Anti-coagulation medication (i.e. Warfarin)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Control
Sham treatment in identical format to treatment arm but without shockwave production
Device: Extracorporeal shockwave therapy
Ultrasonic shockwaves targeted at calf muscle bulk using the Piezowave 2 device (Richard Wolf, Knittlingen, Germany)
Other Names:
  • external shockwave
Experimental: Shockwave
Active shockwave treatment to calf muscle bulk
Device: Extracorporeal shockwave therapy
Ultrasonic shockwaves targeted at calf muscle bulk using the Piezowave 2 device (Richard Wolf, Knittlingen, Germany)
Other Names:
  • external shockwave

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Walking Distance (MWD)
Time Frame: 12 weeks
Treadmill test
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Claudication Distance
Time Frame: 12 weeks
Distance covered prior to onset of any symptoms
12 weeks
Changes in Ankle Brachial Pressure Index
Time Frame: Week 4, 8 and 12
Week 4, 8 and 12
Changes in Patient reported walking distance
Time Frame: Week 4, 8 and 12
Week 4, 8 and 12
Changes in Quality of life [Short form 36(SF36)
Time Frame: Week 4, 8 and 12
Week 4, 8 and 12
Changes in Quality of life [EuroQoL (EQ5D)]
Time Frame: Week 4, 8 and 12
Week 4, 8 and 12
Subject tolerance of treatment
Time Frame: Week 4
Questionnaire including visual analogue pain scales
Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hull University Teaching Hospitals NHS Trust

Collaborators

University of Hull

Investigators

  • Principal Investigator: Ian Chetter, Hull and East Yorkshire Hospital Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2015

Primary Completion (Actual)

July 31, 2020

Study Completion (Estimated)

October 31, 2025

Study Registration Dates

First Submitted

October 17, 2014

First Submitted That Met QC Criteria

January 8, 2016

First Posted (Estimated)

January 11, 2016

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Shockwave 1
  • 166137 (Other Identifier: IRAS project ID)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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