NCT02652078: ESWT

Shockwave Therapy in Lower Limb Intermittent Calf Claudication

Active, enrolled NA Last updated 31 January 2025

What this trial tests

NA trial testing Extracorporeal shockwave therapy in Peripheral Vascular Disease in 138 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

11 May 2015

Primary endpoint
31 July 2020

1 February 2030

Quick facts

Lead sponsor	Hull University Teaching Hospitals NHS Trust
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	138
Start date	11 May 2015
Primary completion	31 July 2020
Estimated completion	1 February 2030
Sites	1 location across United Kingdom

Drugs / interventions tested

• Extracorporeal shockwave therapy

Conditions studied

• Peripheral Vascular Disease — all drugs for Peripheral Vascular Disease →

Sponsor

Hull University Teaching Hospitals NHS Trust

Who can join

18 and older, any sex, with Peripheral Vascular Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Extracorporeal shockwave therapy for the treatment of lower limb intermittent claudication: study protocol for a randomised controlled trial (the SHOCKWAVE 1 trial).
   Cayton T, Harwood AE, Smith GE, Totty JP, et al · · 2017 · cited 7× · PMID 28264725 · DOI 10.1186/s13063-017-1844-4
2. Extracorporeal shockwave therapy for intermittent claudication: Medium-term outcomes from a double-blind randomised placebo-controlled pilot trial.
   Green JL, Harwood AE, Smith GE, Das T, et al · · 2018 · cited 4× · PMID 29722640 · DOI 10.1177/1708538118773618
3. Extracorporeal Shockwave for Intermittent Claudication and Quality of Life: A Randomized Clinical Trial.
   Cai P, Pymer S, Ibeggazene S, Raza A, et al · · 2024 · cited 2× · PMID 38598227 · DOI 10.1001/jamasurg.2024.0625