Control Clinical Trial
— NERVESOfficial title:
Electrical Stimulation in Diabetic Peripheral Neuropathy
Verified date | October 2020 |
Source | Imperial College London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To assess the effect of the device on the progression of diabetic peripheral neuropathy
Status | Completed |
Enrollment | 14 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Academic Vascular Surgery, Charing Cross Hospital | London |
Lead Sponsor | Collaborator |
---|---|
Imperial College London |
United Kingdom,
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Nerve Conduction Speed (Common Peroneal Nerve) | Baseline, 10 weeks | ||
Secondary | 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 |
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