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Completed

NCT Number: NCT02082145

Electrical Stimulation in Diabetic Peripheral Neuropathy

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

Completed

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Academic Vascular Surgery, Charing Cross Hospital

London, W6 8RF, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

NMES

Device

Application of NMES device bilaterally, once a day, 5 times a week, for 10 weeks

Primary outcomes

  1. Nerve Conduction Speed (Common Peroneal Nerve)

    Time frame: Baseline, 10 weeks

Secondary outcomes

  1. PAID - Quality of Life Questionnaires

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Acronym: NERVES

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 10, 2014
Registry last updated
Oct 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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