Clinical Trials Logo

Clinical Trial Summary

To obtain preliminary estimates of the safety and efficacy of the ANS Eon™ Implantable Pulse Generator with ANS leads in the treatment of subjects with diabetic polyneuropathy.


Clinical Trial Description

There is a medication arm and a stimulation arm. Patients will randomized to one or the other. If patients are randomized to the medication arm, after 6 months they have the option of going into the stimulation arm. There is a 3 week trial which includes a crossover period from "no stimulation" to subthreshold stimulation. The 3rd week patients will receive "optimal" stimulation. If they qualify, they will be implanted with the permanent device. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01536236
Study type Interventional
Source Abbott Medical Devices
Contact
Status Withdrawn
Phase N/A
Start date October 2011
Completion date October 2014

See also
  Status Clinical Trial Phase
Recruiting NCT06040567 - Polyneuropathy, Impairments and Physical Activity - The PolyImPAct Study
Completed NCT02423434 - Evaluation of Corneal Confocal Microscopy for the Identification and Prediction of Neuropathy in Type 1 Diabetes
Completed NCT05542901 - Comparison of Joint Position Sense in Diabetic and Traumatic Transtibial Amputees N/A
Active, not recruiting NCT01175928 - Pneumatic Medicine: A Transformative Treatment for Diabetic Peripheral Neuropathy Phase 1/Phase 2
Completed NCT00993070 - Efficacy and Safety Study of Topical Capsaicin in Painful Diabetic Neuropathy Phase 2/Phase 3
Completed NCT00539175 - Treatment of Painful Diabetic Neuropathy With Photon Stimulation N/A
Completed NCT00278980 - Effect of C-Peptide on Diabetic Peripheral Neuropathy Phase 2
Completed NCT04593992 - HTEMS Treatment of Diabetic Polyneuropathy N/A
Completed NCT01465620 - Dietetic and Hygiene Measures in Metabolic Neuropathies: the Neurodiet Study Phase 3
Completed NCT01079325 - Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy Phase 2
Completed NCT00406458 - Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy Phase 2
Recruiting NCT06071975 - Long Term Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Diabetic Polyneuropathy Phase 3
Recruiting NCT06072573 - Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Diabetic Polyneuropathy Phase 3
Recruiting NCT05521737 - Effect of Electroacupuncture on Sensitive Symptoms of Distal Diabetic Peripheral Neuropathy N/A
Completed NCT01847937 - Magnetic Resonance Diagnostics of Diabetic Peripheral Neuropathy N/A
Completed NCT00476931 - Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy Phase 2
Completed NCT00977483 - Assessment of Efficacy and Safety of Thioctic Acid in the Oral Treatment of Diabetic Polyneuropathy (Stage 1 or 2) Phase 3
Completed NCT01006915 - Surgical Decompression for Diabetic Neuropathy in the Foot N/A
Completed NCT00501202 - Study for Safety and Effectiveness of RWJ-333369 (Carsibamate) for the Treatment of Diabetic Peripheral Neuropathy (DPN). Phase 2
Completed NCT00307749 - Safety and Efficacy of MCC-257 in the Treatment of Diabetic Polyneuropathy Phase 2