Shockwave Therapy in Lower Limb Intermittent Calf Claudication

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Peripheral Vascular Disease

Intervention / Treatment
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* Device: Extracorporeal shockwave therapy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control<br>Sham treatment in identical format to treatment arm but without shockwave production | Device: Extracorporeal shockwave therapy<br>* Ultrasonic shockwaves targeted at calf muscle bulk using the Piezowave 2 device (Richard Wolf, Knittlingen, Germany)<br>* Other names: external shockwave;|
| Experimental: Shockwave<br>Active shockwave treatment to calf muscle bulk | Device: Extracorporeal shockwave therapy<br>* Ultrasonic shockwaves targeted at calf muscle bulk using the Piezowave 2 device (Richard Wolf, Knittlingen, Germany)<br>* Other names: external shockwave;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Walking Distance (MWD) | Treadmill test | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Claudication Distance | Distance covered prior to onset of any symptoms | 12 weeks | 
| Changes in Ankle Brachial Pressure Index |  | Week 4, 8 and 12 | 
| Changes in Patient reported walking distance |  | Week 4, 8 and 12 | 
| 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 | Questionnaire including visual analogue pain scales | Week 4 |