Electrical Stimulation in Diabetic Peripheral Neuropathy

Not Applicable

Completed

• Conditions: NMES; Control
• Interventions: Device: NMES

• Registration Number: NCT02082145
• Lead Sponsor: Imperial College London

Brief Summary

To assess the effect of the device on the progression of diabetic peripheral neuropathy

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-01-09
• Study First Submitted QC: 2014-03-05
• Study First Posted: 2014-03-10
• Study Start: 2014-07
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Results First Submitted: 2019-09-19
• Results First Submitted QC: 2019-09-19
• Results First Posted: 2019-10-11
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-05
• Last Update Posted: 2020-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NMES	NMES	Treated with neuromuscular stimulation of both legs, for 10 weeks

Primary Outcome Measures

Name	Time	Method
Nerve Conduction Speed (Common Peroneal Nerve)	Baseline, 10 weeks

Secondary Outcome Measures

Name	Time	Method
PAID - Quality of Life Questionnaires	Baseline, 10 weeks	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.

Trial Locations

Locations (1)

Academic Vascular Surgery, Charing Cross Hospital; 🇬🇧 London, United Kingdom