| CTRI Number |
CTRI/2024/04/065337 [Registered on: 08/04/2024] Trial Registered Prospectively |
| Last Modified On: |
05/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Early Diagnosis Of Diabetic Foot Disease in pre-ulcer stage. |
|
Scientific Title of Study
|
Radiological Approach For Early Diagnosis Of Diabetic Foot Disease |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shweta Singh |
| Designation |
Junior Resident |
| Affiliation |
Maharani Laxmi Bai Medical College Jhansi |
| Address |
OPD Building Room no. 132, Department Of Radiodiagnosis
Maharani Laxmi Bai Medical College Jhansi
Jhansi
UTTAR PRADESH
284128
India |
| Phone |
8933031624 |
| Fax |
|
| Email |
drshwetasinghpatel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rachna Chaurasia |
| Designation |
Professor |
| Affiliation |
Maharani Laxmi bai medical college Jhansi |
| Address |
OPD Building Room no. 133, Department Of RadiodiagnosisMaharani Laxmi bai medical college jhansi
Jhansi
UTTAR PRADESH
284128
India |
| Phone |
07897038708 |
| Fax |
|
| Email |
rachnachaurasiadr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shweta Singh |
| Designation |
Junior Resident |
| Affiliation |
Maharani Laxmi Bai Medical College Jhansi |
| Address |
OPD Building Room no. 132, Department Of Radiodiagnosis
Maharani Laxmi Bai Medical College Jhansi
Jhansi
UTTAR PRADESH
284128
India |
| Phone |
8933031624 |
| Fax |
|
| Email |
drshwetasinghpatel@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Radiodiagnosis, Maharani Laxmi Bai Medical College, Jhansi (284128)
Uttar Pradesh
INDIA
|
|
|
Primary Sponsor
|
| Name |
Maharani Laxmi Bai Medical College Jhansi |
| Address |
kanpur Road, Bundelkhand University, Jhansi (284128)
Uttar Pradesh
INDIA |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shweta Singh |
Maharani Laxmi Bai Medical College |
OPD Building Room No. 132 Department of Radiodiagnosis
Jhansi
UTTAR PRADESH |
8933031624
drshwetasinghpatel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of Ethics Committee (Human Studies) MLB Medical College Jhansi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E114||Type 2 diabetes mellitus with neurological complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound (USG) and Magnetic Resonance Imaging (MRI) |
Evaluation of Early Diagnosis of Diabetic Foot Disease (USG). Duration-30 minutes.
Evaluation of Early Diagnosis of Diabetic Foot Disease (MRI). Duration-40 minutes. |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All consenting patients falling between age group 10 to 70 years with history of uncontrolled diabetes mellitus presenting with or without clinical signs or symptoms of diabetic foot disease. |
|
| ExclusionCriteria |
| Details |
Patients who refuse to participate.
Peripheral neuropathy patients but non diabetic (known case of gout, leprosy, traumatic or other neuropathy)
patients with history of smoking and hypertension
Patients who have peripheral venous disease. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ultrasound is sensitive and cost effective modality for early diagnosis of diabetic foot disease, however Magnetic resonance imaging is more sensitive in detecting diabetic neuropathy though it is highly expensive, low cost effective and not widely available. |
On first visit & follow up at an interval of 4 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate early neuropathy & vasculopathy changes in pre ulcerative stage of diabetic foot disease. |
On first visit & follow up at an interval of 4 weeks. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
16/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/04/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The total number of patients included in our study was 50 satisfying our inclusion criteria. All the patients presented with altered blood sugar test with and without clinical sign and symptoms like burning or pin & needle sensation over foot, skin discoloration, paraesthesia, referred to radiology department for diagnosis. All patients undergoes for ultrasonographic (USG) evaluation.
The patients which are normal/non diagnostic are switched to magnetic resonance imaging (MRI) for further evaluation. In case of normal findings on MRI patients are followed up at an interval of 3-6 months. In case of abnormal MRI findings appropriate management is advised & follow up.
The patients showing abnormal findings on USG are managed conservatively & followed up at an interval of 4-6 weeks. |