Shockwave Therapy in Lower Limb Intermittent Calf Claudication

Not Applicable

Active, not recruiting

• Conditions: Peripheral Vascular Disease
• Interventions: Device: Extracorporeal shockwave therapy

• Registration Number: NCT02652078
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2014-10-17
• Study Start: 2015-05-11
• Study First Submitted QC: 2016-01-08
• Study First Posted: 2016-01-11
• Primary Completion: 2020-07-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-31
• Study Completion: 2030-02-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 138

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Extracorporeal shockwave therapy	Sham treatment in identical format to treatment arm but without shockwave production
Shockwave	Extracorporeal shockwave therapy	Active shockwave treatment to calf muscle bulk

Primary Outcome Measures

Name	Time	Method
Maximum Walking Distance (MWD)	12 weeks	Treadmill test

Secondary Outcome Measures

Name	Time	Method
Changes in Ankle Brachial Pressure Index	Week 4, 8 and 12
Changes in Patient reported walking distance	Week 4, 8 and 12
Claudication Distance	12 weeks	Distance covered prior to onset of any symptoms
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
Subject tolerance of treatment	Week 4	Questionnaire including visual analogue pain scales

Trial Locations

Locations (1)

Academic Vascular Surgery Unit; 🇬🇧 Hull, Yorkshire, United Kingdom