Electrical Stimulation in Diabetic Peripheral Neuropathy

Study Overview
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Brief Summary
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To assess the effect of the device on the progression of diabetic peripheral neuropathy

Detailed Description
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Diabetes is a metabolic disease that affects the body's ability to control blood sugar levels. This affects the tissues of the body, particularly the walls of blood vessels. People with diabetes are more likely to suffer from ischaemic heart disease, stroke, kidney problems, blindness, foot ulcers, and peripheral nerve problems. Diabetes affects approximately 347 million people worldwide, and by 2030 the WHO projects that complications of diabetes will be the 7th leading cause of death. Peripheral neuropathy is a dysfunction of the nerves most commonly affecting the arms and legs. Diabetes is the leading cause of neuropathy in the Western world, and diabetic neuropathy is estimated to affect between 20-50% of diabetic people. The American Diabetes Association define it as the 'presence of symptoms and signs of peripheral nerve dysfunction in patients with diabetes after exclusion of other causes'. As regards complications of diabetes, peripheral neuropathy has the greatest detrimental effect on quality of life. Diabetic neuropathy is implicated in 50-75% of non-traumatic amputations. The device to be tested mimics the effect of walking by stimulating the motor nerves of the leg, making the foot twitch- it increases blood flow to the limb and exercises the leg muscles. We have seen previous clinical cases of improvement in peripheral neuropathy with use of the device, and wish to formalise the benefits to patients. It is hypothesised to work either by increasing blood flow to the limb and therefore the nerves themselves, or for electrical current to be having a direct effect on the peripheral nervous system itself. The device is easily fitted, can be self-administered by patients, and is suitable for out-patient therapy. We wish to evaluate both the short- and longer-term effects of a neuromuscular stimulator on diabetic peripheral neuropathy as a therapeutic intervention.

Official Title
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Electrical Stimulation in Diabetic Peripheral Neuropathy

Conditions
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NMES, Control

Intervention / Treatment
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* Device: NMES


Participation Criteria
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Eligibility Criteria
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Inclusion criteria 18+ years old Diabetes as defined by WHO diagnostic criteria on best medical therapy Diabetic peripheral polyneuropathy present, confirmed by nerve conduction testing Exclusion criteria Pregnancy Pacemaker Metal implants in the legs (below knee)

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Treated according to local protocol for diabetic peripheral neuropathy | |
| Experimental: NMES<br>Treated with neuromuscular stimulation of both legs, for 10 weeks | Device: NMES<br>* Application of NMES device bilaterally, once a day, 5 times a week, for 10 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nerve Conduction Speed (Common Peroneal Nerve) |  | Baseline, 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PAID - Quality of Life Questionnaires | PAID (Problem Areas in Diabetes) is a self-administered 20-item scale. Each item is scored from 0 (not a problem) to 4 (serious problem). The sum of all item scores multiplied by 1.25 gives the total PAID score, which ranges from 0 to 100, higher scores reflecting greater emotional distress. | Baseline, 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NMES, diabetic peripheral neuropathy