Clinical trial NCT02082145: Electrical Stimulation in Diabetic Peripheral Neuropathy
Official title: Electrical Stimulation in Diabetic Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: NMES
Control
Keywords: NMES
diabetic peripheral neuropathy
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2014-03-10
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Nerve Conduction Speed (Common Peroneal Nerve)
timeFrame: Baseline, 10 weeks
Secondary outcomes:
measure: PAID - Quality of Life Questionnaires
timeFrame: Baseline, 10 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Academic Vascular Surgery, Charing Cross Hospital
Study officials:
affiliation: Imperial College London
name: A H Davies
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kluding PM, Pasnoor M, Singh R, Jernigan S, Farmer K, Rucker J, Sharma NK, Wright DE. The effect of exercise on neuropathic symptoms, nerve function, and cutaneous innervation in people with diabetic peripheral neuropathy. J Diabetes Complications. 2012 Sep-Oct;26(5):424-9. doi: 10.1016/j.jdiacomp.2012.05.007. Epub 2012 Jun 18.
citation: Balducci S, Iacobellis G, Parisi L, Di Biase N, Calandriello E, Leonetti F, Fallucca F. Exercise training can modify the natural history of diabetic peripheral neuropathy. J Diabetes Complications. 2006 Jul-Aug;20(4):216-23. doi: 10.1016/j.jdiacomp.2005.07.005.