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Peripheral Vascular DiseaseESWTNCT02652078

Shockwave Therapy in Lower Limb Intermittent Calf Claudication

A study testing Extracorporeal shockwave therapy in people with Peripheral Vascular Disease, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peripheral Vascular Disease
What is being tested?
Extracorporeal shockwave therapy
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
138 participants
Where
1 siteUnited Kingdom
Study dates
11 May 2015to 1 Feb 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Academic Vascular Surgery Unit

    Hull, Yorkshire, HU3 2JZ

Other trials in United Kingdom

About this study

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

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.

Read the 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.

Being tested
Extracorporeal shockwave therapy
Medical subject headings
Peripheral Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Extracorporeal shockwave therapyDevice

    Also called external shockwave

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

Study groups in NCT02652078
Study groupRoleWhat they receive
ControlSham comparatorSham treatment in identical format to treatment arm but without shockwave production
Receives: Device: Extracorporeal shockwave therapy
ShockwaveExperimentalActive shockwave treatment to calf muscle bulk
Receives: Device: Extracorporeal shockwave therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Walking Distance (MWD)

    Treadmill test

    Measured: 12 weeks

Secondary outcomes (6)

  1. Claudication Distance

    Distance covered prior to onset of any symptoms

    Measured: 12 weeks

  2. Changes in Ankle Brachial Pressure Index

    Measured: Week 4, 8 and 12

  3. Changes in Patient reported walking distance

    Measured: Week 4, 8 and 12

  4. Changes in Quality of life [Short form 36(SF36)

    Measured: Week 4, 8 and 12

  5. Changes in Quality of life [EuroQoL (EQ5D)]

    Measured: Week 4, 8 and 12

  6. Subject tolerance of treatment

    Questionnaire including visual analogue pain scales

    Measured: Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2016 (estimated)
  2. Study start11 May 2015
  3. Primary completion31 Jul 2020
  4. Study completion1 Feb 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
138 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02652078
Sponsor's protocol ID
Shockwave 1
Other IDs
166137
Acronym
ESWT
Status last verified
Jun 2026
First submitted
17 Oct 2014
Last updated
18 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 29722640

  • 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.

    PubMed 38598227

  • 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.

    PubMed 28943002

  • 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.

    PubMed 28264725

Questions about this trial

What is this clinical trial studying?

A study testing Extracorporeal shockwave therapy in people with Peripheral Vascular Disease, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Walking Distance (MWD) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02652078, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.

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