| CTRI Number |
CTRI/2025/09/094074 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
15/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of Efficacy of TCNS and Biothesiometry in Detecting Diabetic Peripheral Neuropathy |
|
Scientific Title of Study
|
Assessment of Accuracy of the Toronto Clinical Neuropathy Scoring System and
Vibration Perception Threshold in Diagnosing Diabetic Peripheral Neuropathy in Type
2 Diabetes Mellitus Patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Helana Jabeen |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Bhopal |
| Address |
Room 2, Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Saket Nagar, 462020, Bhopal, Madhya Pradesh
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9645332656 |
| Fax |
|
| Email |
helanajabeen@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vithal P Puri |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhopal |
| Address |
Room 2, Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Saket Nagar, 462020, Bhopal, Madhya Pradesh
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9645332656 |
| Fax |
|
| Email |
puri.pmr@aiimsbhopal.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Helana Jabeen |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Bhopal |
| Address |
Room 2, Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Saket Nagar, 462020, Bhopal, Madhya Pradesh
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9645332656 |
| Fax |
|
| Email |
helanajabeen@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Saket Nagar, Bhopal, Madhya Pradesh, Pin: 462020 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Bhopal |
| Address |
Research Cell, Kautilya Bhavan, AIIMS, Bhopal, Saket Nagar, Madhya Pradesh, India 462020 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Rajnish Joshi |
Dean (Academics), Department of General Medicine, Ground Floor, AIIMS, Bhopal |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Helana Jabeen |
All India Institute of Medical Sciences, Bhopal |
Room 13, Department of Physical Medicine and Rehabilitation, Ground Floor
Bhopal
MADHYA PRADESH |
9645332656
helanajabeen@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee - Student Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of diabetes mellitus |
|
| ExclusionCriteria |
| Details |
Individuals with active foot ulcers or amputations
Patients with other causes of peripheral neuropathy like Hansens disease, deficiencies etc.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the diagnostic accuracy of the Toronto Clinical Neuropathy Scoring
System and Vibration Perception Threshold with nerve conduction studies in
detecting diabetic peripheral neuropathy in patients with type 2 diabetes mellitus. |
At 18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the correlation between the duration of diabetes & NCS parameters.
|
At 18 months |
To assess the correlation between glycaemic control, lipid profile & NCS
parameters. |
At 18 months |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Diabetic peripheral neuropathy is a common and serious complication of type 2 diabetes mellitus, often leading to significant morbidity including foot ulcers and amputations. While nerve conduction studies are considered the gold standard for diagnosing DPN, they are expensive, time-consuming, and not always readily available in all clinical settings. The Toronto Clinical Neuropathy Scoring System and Vibration Perception Threshold are simpler, less expensive alternatives that could potentially be used for screening and diagnosis. However, their diagnostic accuracy compared to NCS in detecting DPN has not been thoroughly established. This study aims to evaluate the effectiveness of TCNS and VPT compared to NCS, potentially providing clinicians with more accessible tools for early detection and management of DPN. The results could lead to improved screening practices, earlier interventions, and better outcomes for patients with type 2 diabetes mellitus. |