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Shockwave Therapy in Lower Limb Intermittent Calf Claudication (SLICC)

Primary Purpose

Peripheral Vascular Disease

Status
Active
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Extracorporeal shockwave therapy
Sponsored by
Hull University Teaching Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Vascular Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Academic Vascular Surgery Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Control

Shockwave

Arm Description

Sham treatment in identical format to treatment arm but without shockwave production

Active shockwave treatment to calf muscle bulk

Outcomes

Primary Outcome Measures

Maximum Walking Distance (MWD)
Treadmill test

Secondary Outcome Measures

Claudication Distance
Distance covered prior to onset of any symptoms
Changes in Ankle Brachial Pressure Index
Changes in Patient reported walking distance
Changes in Quality of life [Short form 36(SF36)
Changes in Quality of life [EuroQoL (EQ5D)]
Subject tolerance of treatment
Questionnaire including visual analogue pain scales

Full Information

First Posted
October 17, 2014
Last Updated
March 30, 2023
Sponsor
Hull University Teaching Hospitals NHS Trust
Collaborators
University of Hull
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1. Study Identification

Unique Protocol Identification Number
NCT02652078
Brief Title
Shockwave Therapy in Lower Limb Intermittent Calf Claudication
Acronym
SLICC
Official Title
Extracorporeal Shockwave Therapy in the Treatment of Intermittent Claudication Symptoms in Peripheral Vascular Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 11, 2015 (Actual)
Primary Completion Date
July 31, 2020 (Actual)
Study Completion Date
October 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hull University Teaching Hospitals NHS Trust
Collaborators
University of Hull

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Vascular Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Sham treatment in identical format to treatment arm but without shockwave production
Arm Title
Shockwave
Arm Type
Experimental
Arm Description
Active shockwave treatment to calf muscle bulk
Intervention Type
Device
Intervention Name(s)
Extracorporeal shockwave therapy
Other Intervention Name(s)
external shockwave
Intervention Description
Ultrasonic shockwaves targeted at calf muscle bulk using the Piezowave 2 device (Richard Wolf, Knittlingen, Germany)
Primary Outcome Measure Information:
Title
Maximum Walking Distance (MWD)
Description
Treadmill test
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Claudication Distance
Description
Distance covered prior to onset of any symptoms
Time Frame
12 weeks
Title
Changes in Ankle Brachial Pressure Index
Time Frame
Week 4, 8 and 12
Title
Changes in Patient reported walking distance
Time Frame
Week 4, 8 and 12
Title
Changes in Quality of life [Short form 36(SF36)
Time Frame
Week 4, 8 and 12
Title
Changes in Quality of life [EuroQoL (EQ5D)]
Time Frame
Week 4, 8 and 12
Title
Subject tolerance of treatment
Description
Questionnaire including visual analogue pain scales
Time Frame
Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian Chetter
Organizational Affiliation
Hull and East Yorkshire Hospital Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Academic Vascular Surgery Unit
City
Hull
State/Province
Yorkshire
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
29722640
Citation
Green JL, Harwood AE, Smith GE, Das T, Raza A, Cayton T, Wallace T, Carradice D, Chetter IC. Extracorporeal shockwave therapy for intermittent claudication: Medium-term outcomes from a double-blind randomised placebo-controlled pilot trial. Vascular. 2018 Oct;26(5):531-539. doi: 10.1177/1708538118773618. Epub 2018 May 3.
Results Reference
result
PubMed Identifier
28943002
Citation
Harwood AE, Green J, Cayton T, Raza A, Wallace T, Carradice D, Chetter IC, Smith GE. A feasibility double-blind randomized placebo-controlled trial of extracorporeal shockwave therapy as a novel treatment for intermittent claudication. J Vasc Surg. 2018 Feb;67(2):514-521.e2. doi: 10.1016/j.jvs.2017.07.105. Epub 2017 Sep 22.
Results Reference
derived
PubMed Identifier
28264725
Citation
Cayton T, Harwood AE, Smith GE, Totty JP, Carradice D, Chetter IC. Extracorporeal shockwave therapy for the treatment of lower limb intermittent claudication: study protocol for a randomised controlled trial (the SHOCKWAVE 1 trial). Trials. 2017 Mar 6;18(1):104. doi: 10.1186/s13063-017-1844-4.
Results Reference
derived
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/29722640?dopt=Abstract
Description
Publication Link

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Shockwave Therapy in Lower Limb Intermittent Calf Claudication

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