Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000014550
Ethics application status
Approved
Date submitted
9/01/2006
Date registered
9/01/2006
Date last updated
9/01/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
A novel sensory nerve stimulator to improve neuropathy in patients with diabetes
Scientific title
The use of low frequency transcutaneous sensory nerve stimulation to improve sensory nerve function and symptoms in people with diabetic peripheral neuropathy
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic peripheral neuropathy 975 0
Condition category
Condition code
Metabolic and Endocrine 1049 1049 0 0
Diabetes
Neurological 1050 1050 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Double blind placebo randomised controlled trial of low frequency sensory electrical nerve stimulation within two different population groups over 12 weeks of treatment.
Intervention code [1] 828 0
Treatment: Devices
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 1404 0
Comparison of the effect of treatment on vascular measures
Timepoint [1] 1404 0
From baseline to 12 weeks post treatment
Primary outcome [2] 1405 0
Comparison of the effect of treatment on neuronal measures
Timepoint [2] 1405 0
From baseline to 12 weeks post treatment
Secondary outcome [1] 2479 0
Comparison of the effect of treatment on subjective sensory measures.
Timepoint [1] 2479 0
From baseline to 12 weeks post treatment.

Eligibility
Key inclusion criteria
Group 1: Persons aged 55 to 65, with known diabetes duration of up to 5 years.Group 2: Persons aged 55 to 75, with known diabetes duration of up to 10 years.DPN diagnosed as insensate to 10g monofilament or reduced vibration below 4octals 128Hz graduated tuning fork.
Minimum age
55 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to consent to the research, an above or below-knee amputation, cigarette smoking.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed for the duration of the trial in sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation to ensure randomisation of placebo and active is even regardless of sample size, with the random allocation sequence formulated by using a random number table in excel
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/02/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
220
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1147 0
Government body
Name [1] 1147 0
NH&MRC
Country [1] 1147 0
Australia
Primary sponsor type
Individual
Name
A/Prof Zeinab Khalil
Address
Country
Secondary sponsor category [1] 1004 0
University
Name [1] 1004 0
University of Melbourne, Department of Biochemistry and Molecular Biology
Address [1] 1004 0
Country [1] 1004 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2471 0
Royal Melbourne Hospital
Ethics committee address [1] 2471 0
Ethics committee country [1] 2471 0
Australia
Date submitted for ethics approval [1] 2471 0
Approval date [1] 2471 0
Ethics approval number [1] 2471 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36351 0
Address 36351 0
Country 36351 0
Phone 36351 0
Fax 36351 0
Email 36351 0
Contact person for public queries
Name 10017 0
Rajna Ogrin
Address 10017 0
Department of Biochemistry and Molecular Biology
University of Melbourne
Parkville VIC 3010
Country 10017 0
Australia
Phone 10017 0
+61 3 83445919
Fax 10017 0
+61 3 93482251
Email 10017 0
[email protected]
Contact person for scientific queries
Name 945 0
Rajna Ogrin
Address 945 0
Department of Biochemistry and Molecular Biology
University of Melbourne
Parkville VIC 3010
Country 945 0
Australia
Phone 945 0
+61 3 83445919
Fax 945 0
+61 3 93482251
Email 945 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.