Clinical trial NCT02652078: Shockwave Therapy in Lower Limb Intermittent Calf Claudication
Official title: Extracorporeal Shockwave Therapy in the Treatment of Intermittent Claudication Symptoms in Peripheral Vascular Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Peripheral Vascular Disease
Lead sponsor: Hull University Teaching Hospitals NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: University of Hull
First posted: 2016-01-11
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Maximum Walking Distance (MWD)
timeFrame: 12 weeks
Secondary outcomes:
measure: Claudication Distance
timeFrame: 12 weeks
measure: Changes in Ankle Brachial Pressure Index
timeFrame: Week 4, 8 and 12
measure: Changes in Patient reported walking distance
timeFrame: Week 4, 8 and 12
measure: Changes in Quality of life [Short form 36(SF36)
timeFrame: Week 4, 8 and 12
measure: Changes in Quality of life [EuroQoL (EQ5D)]
timeFrame: Week 4, 8 and 12
measure: Subject tolerance of treatment
timeFrame: Week 4
Other outcomes:
Locations:
city: Hull
country: United Kingdom
facility: Academic Vascular Surgery Unit
state: Yorkshire
Study officials:
affiliation: Hull and East Yorkshire Hospital Trust
name: Ian Chetter
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Cai 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.
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.
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.