Electrical Stimulation in Diabetic Peripheral Neuropathy
NERVES
2 other identifiers
interventional
14
1 country
1
Brief Summary
To assess the effect of the device on the progression of diabetic peripheral neuropathy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2014
CompletedFirst Posted
Study publicly available on registry
March 10, 2014
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedResults Posted
Study results publicly available
October 11, 2019
CompletedOctober 27, 2020
October 1, 2020
1.4 years
January 9, 2014
September 19, 2019
October 5, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Nerve Conduction Speed (Common Peroneal Nerve)
Baseline, 10 weeks
Secondary Outcomes (1)
PAID - Quality of Life Questionnaires
Baseline, 10 weeks
Study Arms (2)
Control
NO INTERVENTIONTreated according to local protocol for diabetic peripheral neuropathy
NMES
EXPERIMENTALTreated with neuromuscular stimulation of both legs, for 10 weeks
Interventions
Eligibility Criteria
You may qualify if:
- + years old
- Diabetes as defined by WHO diagnostic criteria on best medical therapy
- Diabetic peripheral polyneuropathy present, confirmed by nerve conduction testing
You may not qualify if:
- Pregnancy
- Pacemaker
- Metal implants in the legs (below knee)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Academic Vascular Surgery, Charing Cross Hospital
London, W6 8RF, United Kingdom
Related Publications (2)
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.
PMID: 22717465BACKGROUNDBalducci 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.
PMID: 16798472BACKGROUND
Limitations and Caveats
Results are limited by both patient availability for nerve conduction studies, and the return of questionnaires. All patients were followed up, and all adverse results were reported.
Results Point of Contact
- Title
- Miss Kate Williams
- Organization
- Imperial College London
Study Officials
- PRINCIPAL INVESTIGATOR
A H Davies
Imperial College London
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2014
First Posted
March 10, 2014
Study Start
July 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
October 27, 2020
Results First Posted
October 11, 2019
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share