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Active, Not Recruiting

NCT Number: NCT02652078

Shockwave Therapy in Lower Limb Intermittent Calf Claudication

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Peripheral Vascular Disease Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Academic Vascular Surgery Unit

Hull, Yorkshire, HU3 2JZ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Extracorporeal shockwave therapy

Device

Ultrasonic shockwaves targeted at calf muscle bulk using the Piezowave 2 device (Richard Wolf, Knittlingen, Germany)

Other names: external shockwave

Primary outcomes

  1. Maximum Walking Distance (MWD)

    Time frame: 12 weeks

    Treadmill test

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hull University Teaching Hospitals NHS Trust

Other Gov

Collaborators

  • University of Hull

Registry information

Official study title

Extracorporeal Shockwave Therapy in the Treatment of Intermittent Claudication Symptoms in Peripheral Vascular Disease

Acronym: ESWT

Important dates

Study start
2015
Primary completion
2020
Study completion
2030
First posted
Jan 11, 2016
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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