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Electrical Stimulation in Diabetic Peripheral Neuropathy (NERVES)

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ClinicalTrials.gov Identifier: NCT02082145
Recruitment Status : Completed
First Posted : March 10, 2014
Results First Posted : October 11, 2019
Last Update Posted : October 27, 2020
Sponsor:
Information provided by (Responsible Party):
Imperial College London

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

Condition or disease Intervention/treatment Phase
NMES Control Device: NMES Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Electrical Stimulation in Diabetic Peripheral Neuropathy
Actual Study Start Date : July 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
Treated according to local protocol for diabetic peripheral neuropathy
Experimental: NMES
Treated with neuromuscular stimulation of both legs, for 10 weeks
Device: NMES
Application of NMES device bilaterally, once a day, 5 times a week, for 10 weeks




Primary Outcome Measures :
  1. Nerve Conduction Speed (Common Peroneal Nerve) [ Time Frame: Baseline, 10 weeks ]

Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02082145


Locations
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United Kingdom
Academic Vascular Surgery, Charing Cross Hospital
London, United Kingdom, W6 8RF
Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: A H Davies Imperial College London
Publications:
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT02082145    
Other Study ID Numbers: 13/LO/1844
13HH1825 ( Other Identifier: Imperial College London )
First Posted: March 10, 2014    Key Record Dates
Results First Posted: October 11, 2019
Last Update Posted: October 27, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
NMES
diabetic peripheral neuropathy
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases