Intermittent Claudication, Peripheral Vascular Disease
Conditions
Keywords
Intermittent Claudication, IC, Peripheral Arterial Disease, Peripheral Vascular Disease, Peripheral Arterial Occlusive Disease
Brief summary
This study will assess the benefit of a neuromuscular electrical stimulation device in patients suffering from symptoms and effects of lower limb intermittent claudication.
Detailed description
The circulation of blood around the body is dependent on effective pumping of the heart. Patients with claudication experience pain or discomfort in their legs usually during activity such as walking, which goes away at rest. Claudication is a symptom of peripheral arterial disease (PAD). If left untreated, patients can develop arterial insufficiency which can lead to various complications such as swelling, painful legs, reduced healing of injuries and the loss of limbs in extreme conditions. PAD can be defined as a narrowing of the arteries reducing blood flow. It is most commonly due to atherosclerosis, and has associations with heart disease, stroke, and diabetes. Its incidence is estimated at 7-14% in the general population, increasing with age to about 20% in the over-seventies. It is associated with effects on mobility, skin condition and quality of life. Symptoms include pain in the legs on walking (intermittent claudication), pain at rest (particularly at night), gangrene, and limb loss. Management of PAD is based on encouraging exercise, and modification of risk factors such as smoking, high blood pressure, high cholesterol and diabetes. In patients with PAD, exercise tolerance is often limited. Severe symptoms and disease can be treated by procedures such as balloon angioplasty, stenting or surgical bypass, but these procedures have risks. There also remains a percentage of patients who are not suitable for revascularisation, and have few options besides amputation available to them. Some trials have shown that increasing the blood flow in the legs over time using medical devices (intermittent pneumatic compression, muscle stimulators), in addition to maximal medical and surgical therapy, can increase claudication distance, absolute walking distance, decrease rest pain, and reduce amputation rates. In our unit it has become apparent that there are an increasing number of medical devices available for circulatory support, either for use as an inpatient, out-patient, or a member of the general public. The supporting evidence for these is variable in scientific and clinical content or relevance, and requires clinical trials to evaluate further. The device being used in this study, activates the pumping action of the leg muscles by providing neuromuscular electrical stimulation (NMES) to cause foot muscle contraction and relaxation. This squeezes blood back towards the heart, improving circulation. The study will evaluate whether NMES using this device has the same beneficial effects in patients with intermittent claudication.
Interventions
DEVICENeuromuscular Electrical Stimulation
Revitive IX neuromuscular electrical stimulation device will be given to all participants as per protocol.
Sponsors
Imperial College London
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All ethnic groups, male or female above the age of 18 years. * Diagnosis of mild intermittent claudication * Be of non-childbearing potential; OR using adequate contraception and have a negative urine pregnancy test result within 24 hours if appropriate before using the study device. * Blood pressure currently under moderate control (\< 160/100mmHg) * No current foot ulceration
Exclusion criteria
* Patients meeting any of the following criteria are to be excluded: * Has an unstable condition (eg, psychiatric disorder, a recent history of substance abuse) or otherwise thought to be unreliable or incapable of complying with the study protocol. * Has diabetes * Ankle Brachial Pressure Index \> 0.9 * Has any metal implants * Pregnant * Has a cardiac pacemaker or defibrillator device * Has recent lower limb injury or lower back pain * Has current foot ulceration or other skin ulcers * Has foot deformities * Has any disorder that, in the opinion of the Investigator, might interfere with the conduct of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Initial Walking Distance | Baseline, 6 weeks | Initial walking distance measured by treadmill For the initial claudication distance measurement, a fixed load treadmill test will be carried out at 3.5 km/h with a 10% gradient. The initial claudication distance (ICD) is the distance walked until the onset of pain. |
| Absolute Walking Distance Measured by Treadmill | Change in baseline treadmill walking distance at 6 weeks | For the absolute claudication distance measurement, a fixed load treadmill test will be carried out at 3.5 km/h with a 10% gradient. The absolute claudication distance (ACD) is the distance walked before the participant is forced to stop due to typical pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptomatic Scores by Questionnaire | Change in baseline questionnaire scores at 6 weeks | Validated questionnaires including the Edinburgh Claudication Questionnaire and Intermittent Claudication Questionnaire will be obtained at baseline and week 6. |
| Quality of Life Scores Measured by Questionnaire | Change in baseline quality of life at 6 weeks | Validated questionnaires including the Euro-Quol 5D and Short Form 36 will be measured at baseline and 6 weeks. |
| Femoral Haemodynamics Measured by Femoral Artery Duplex Ultrasonography | Change in baseline femoral haemodynamics at 6 weeks | Ultrasound assessment of blood flow dynamics in the femoral artery will be obtained at rest, and if randomised to the intervention group, whilst using the device. |
| Serum Metabolic Profile | Change of profile at baseline and 6 weeks | A serum sample will be collected at baseline and at 6 weeks. Mass spectroscopy and nuclear magnetic resonance spectroscopy analysis will be carried out. |
| Urine Metabolic Profile | Change of profile at baseline and at 6 weeks | A urine sample will be collected at baseline and at 6 weeks. Mass spectroscopy and nuclear magnetic resonance spectroscopy analysis will be carried out. |
| Laser Doppler Flow Measured by Optical Laser | Change in baseline flowmetry at 6 weeks | Optical laser flowmetry probes will be used to assess the superficial skin circulation and temperature. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Patients receiving neuromuscular electrical stimulation.
Neuromuscular Electrical Stimulation: Revitive IX neuromuscular electrical stimulation device will be given to all participants as per protocol. | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Significant outlier | 1 |
Baseline characteristics
| Characteristic | Intervention |
|---|---|
| Age, Continuous | 70 years STANDARD_DEVIATION 11.7 |
| Ankle Brachial Pressure Index - ABPI (Left) | 0.69 Ratio STANDARD_DEVIATION 0.17 |
| Ankle Brachial Pressure Index - ABPI (Right) | 0.71 Ratio STANDARD_DEVIATION 0.17 |
| Body Mass Index - BMI | 27.4 kg/m^2 STANDARD_DEVIATION 4.5 |
| Initial Claudication Distance - ICD (m) | 37.7 m |
| Maximum Claudication Distance - MCD (m) | 89.3 m |
| Region of Enrollment United Kingdom | 20 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Absolute Walking Distance Measured by Treadmill
For the absolute claudication distance measurement, a fixed load treadmill test will be carried out at 3.5 km/h with a 10% gradient. The absolute claudication distance (ACD) is the distance walked before the participant is forced to stop due to typical pain.
Time frame: Change in baseline treadmill walking distance at 6 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention | Absolute Walking Distance Measured by Treadmill | 130 m |
Primary
Change From Baseline in Initial Walking Distance
Initial walking distance measured by treadmill For the initial claudication distance measurement, a fixed load treadmill test will be carried out at 3.5 km/h with a 10% gradient. The initial claudication distance (ICD) is the distance walked until the onset of pain.
Time frame: Baseline, 6 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention | Change From Baseline in Initial Walking Distance | 64.3 metres |
Secondary
Femoral Haemodynamics Measured by Femoral Artery Duplex Ultrasonography
Ultrasound assessment of blood flow dynamics in the femoral artery will be obtained at rest, and if randomised to the intervention group, whilst using the device.
Time frame: Change in baseline femoral haemodynamics at 6 weeks
Secondary
Laser Doppler Flow Measured by Optical Laser
Optical laser flowmetry probes will be used to assess the superficial skin circulation and temperature.
Time frame: Change in baseline flowmetry at 6 weeks
Secondary
Quality of Life Scores Measured by Questionnaire
Validated questionnaires including the Euro-Quol 5D and Short Form 36 will be measured at baseline and 6 weeks.
Time frame: Change in baseline quality of life at 6 weeks
Secondary
Serum Metabolic Profile
A serum sample will be collected at baseline and at 6 weeks. Mass spectroscopy and nuclear magnetic resonance spectroscopy analysis will be carried out.
Time frame: Change of profile at baseline and 6 weeks
Secondary
Symptomatic Scores by Questionnaire
Validated questionnaires including the Edinburgh Claudication Questionnaire and Intermittent Claudication Questionnaire will be obtained at baseline and week 6.
Time frame: Change in baseline questionnaire scores at 6 weeks
Secondary
Urine Metabolic Profile
A urine sample will be collected at baseline and at 6 weeks. Mass spectroscopy and nuclear magnetic resonance spectroscopy analysis will be carried out.
Time frame: Change of profile at baseline and at 6 weeks