Shockwave Therapy in Lower Limb Intermittent Calf Claudication

Peripheral Vascular Disease Clinical Trial

— SLICC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02652078
• Other study ID #: Shockwave 1
• Secondary ID: 166137
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 11, 2015
• Est. completion date: October 31, 2025

Study information

• Verified date: April 2024
• Source: Hull University Teaching Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 138
• Est. completion date: October 31, 2025
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Device:
• Extracorporeal shockwave therapy
Ultrasonic shockwaves targeted at calf muscle bulk using the Piezowave 2 device (Richard Wolf, Knittlingen, Germany)

Locations

Country	Name	City	State
United Kingdom	Academic Vascular Surgery Unit	Hull	Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
Hull University Teaching Hospitals NHS Trust	University of Hull

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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 Apr 10:e240625. doi: 10.1001/jamasurg.2024.0625. Online ahead of — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Walking Distance (MWD)	Treadmill test	12 weeks
Secondary	Claudication Distance	Distance covered prior to onset of any symptoms	12 weeks
Secondary	Changes in Ankle Brachial Pressure Index		Week 4, 8 and 12
Secondary	Changes in Patient reported walking distance		Week 4, 8 and 12
Secondary	Changes in Quality of life [Short form 36(SF36)		Week 4, 8 and 12
Secondary	Changes in Quality of life [EuroQoL (EQ5D)]		Week 4, 8 and 12
Secondary	Subject tolerance of treatment	Questionnaire including visual analogue pain scales	Week 4

External Links

•   Publication Link