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Shockwave Therapy in Lower Limb Intermittent Calf Claudication (SLICC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02652078
Recruitment Status : Recruiting
First Posted : January 11, 2016
Last Update Posted : November 13, 2019
University of Hull
Information provided by (Responsible Party):
Hull University Teaching Hospitals NHS Trust

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Peripheral Vascular Disease Device: Extracorporeal shockwave therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Extracorporeal Shockwave Therapy in the Treatment of Intermittent Claudication Symptoms in Peripheral Vascular Disease
Actual Study Start Date : June 2015
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

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 Name: 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 Name: external shockwave

Primary Outcome Measures :
  1. Maximum Walking Distance (MWD) [ Time Frame: 12 weeks ]
    Treadmill test

Secondary Outcome Measures :
  1. Claudication Distance [ Time Frame: 12 weeks ]
    Distance covered prior to onset of any symptoms

  2. Changes in Ankle Brachial Pressure Index [ Time Frame: Week 4, 8 and 12 ]
  3. Changes in Patient reported walking distance [ Time Frame: Week 4, 8 and 12 ]
  4. Changes in Quality of life [Short form 36(SF36) [ Time Frame: Week 4, 8 and 12 ]
  5. Changes in Quality of life [EuroQoL (EQ5D)] [ Time Frame: Week 4, 8 and 12 ]
  6. Subject tolerance of treatment [ Time Frame: Week 4 ]
    Questionnaire including visual analogue pain scales

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02652078

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Contact: Thomas Cayton
Contact: George Smith

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United Kingdom
Academic Vascular Surgery Unit Recruiting
Hull, Yorkshire, United Kingdom, HU3 2JZ
Contact: Thomas Cayton, MBChB    01482674643   
Principal Investigator: George E Smith, MBBS MRCS         
Sponsors and Collaborators
Hull University Teaching Hospitals NHS Trust
University of Hull
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Principal Investigator: Ian Chetter Hull and East Yorkshire Hospital Trust

Additional Information:
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Hull University Teaching Hospitals NHS Trust Identifier: NCT02652078     History of Changes
Other Study ID Numbers: Shockwave 1
166137 ( Other Identifier: IRAS project ID )
First Posted: January 11, 2016    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Arterial Occlusive Diseases