Safety and efficacy of Neurotec in reducing pain in patients with diabetic neuropathy - a single armed phase II trial

Phase 2

Active, not recruiting

• Conditions: Diabetic Neuropathy; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12608000388314
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-08-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

having diabetic I or II
having pain and paresthesia interfering with every day activities
Diminished anckle reflex
Abnormal 128 Hz vibration test

Exclusion Criteria

Unwilling to sign a written consent
Non-diabetic neuropathy
Wound infection or infection in extremities
ischaemic heart disease
Heart failure
reeiving immunosuppresive drugs, corticosteroids, chemotherapy, radiotherapy
Alcohol and substance misuse
Electrolyte disturbances
History of known hypersensitivity to drugs
Haemodialysis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain measured by Visual Analogos Scale(VAS)[baseline, 2, 4, 8, 12, 16 and 24 weeks]

Secondary Outcome Measures

Name	Time	Method
Michigan Diabetic Neuropathy score[baseline, 2, 4, 8, 12, 16 and 24 weeks];UK Diabetic Neuropathy score[baseline, 2, 4, 8, 12, 16 and 24 weeks];Semmes-Weinstein monofilament test for peripheral sensory neuropathy[baseline, 2, 4, 8, 12, 16 and 24 weeks]