Shockwave Therapy in Lower Limb Intermittent Calf Claudication
ESWT
Extracorporeal Shockwave Therapy in the Treatment of Intermittent Claudication Symptoms in Peripheral Vascular Disease
2 other identifiers
interventional
138
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2014
CompletedStudy Start
First participant enrolled
May 11, 2015
CompletedFirst Posted
Study publicly available on registry
January 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2030
ExpectedJanuary 31, 2025
January 1, 2025
5.2 years
October 17, 2014
January 29, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Maximum Walking Distance (MWD)
Treadmill test
12 weeks
Secondary Outcomes (6)
Claudication Distance
12 weeks
Changes in Ankle Brachial Pressure Index
Week 4, 8 and 12
Changes in Patient reported walking distance
Week 4, 8 and 12
Changes in Quality of life [Short form 36(SF36)
Week 4, 8 and 12
Changes in Quality of life [EuroQoL (EQ5D)]
Week 4, 8 and 12
- +1 more secondary outcomes
Study Arms (2)
Control
SHAM COMPARATORSham treatment in identical format to treatment arm but without shockwave production
Shockwave
EXPERIMENTALActive shockwave treatment to calf muscle bulk
Interventions
Ultrasonic shockwaves targeted at calf muscle bulk using the Piezowave 2 device (Richard Wolf, Knittlingen, Germany)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hull University Teaching Hospitals NHS Trustlead
- University of Hullcollaborator
Study Sites (1)
Academic Vascular Surgery Unit
Hull, Yorkshire, HU3 2JZ, United Kingdom
Related Publications (4)
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.
PMID: 29722640RESULTCai P, Pymer S, Ibeggazene S, Raza A, Hitchman L, Chetter I, Smith G. Extracorporeal Shockwave for Intermittent Claudication and Quality of Life: A Randomized Clinical Trial. JAMA Surg. 2024 Jun 1;159(6):625-632. doi: 10.1001/jamasurg.2024.0625.
PMID: 38598227RESULTHarwood 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.
PMID: 28943002DERIVEDCayton 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.
PMID: 28264725DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ian Chetter
Hull and East Yorkshire Hospital Trust
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2014
First Posted
January 11, 2016
Study Start
May 11, 2015
Primary Completion
July 31, 2020
Study Completion (Estimated)
February 1, 2030
Last Updated
January 31, 2025
Record last verified: 2025-01