| CTRI Number |
CTRI/2019/05/019041 [Registered on: 10/05/2019] Trial Registered Prospectively |
| Last Modified On: |
07/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Prevalence of high risk foot in diabetes |
|
Scientific Title of Study
|
Prevalence of high risk foot in patients with diabetes |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanjay pandit |
| Designation |
Professor |
| Affiliation |
maulana azad medical college |
| Address |
Room No 126
BL Taneja block
Department of medicine
maulana azad medical college
Central
DELHI
110002
India |
| Phone |
|
| Fax |
|
| Email |
spandit01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjay pandit |
| Designation |
Professor |
| Affiliation |
maulana azad medical college |
| Address |
Room No 126
BL Taneja block
Department of medicine
maulana azad medical college
DELHI
110002
India |
| Phone |
|
| Fax |
|
| Email |
spandit01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanjay pandit |
| Designation |
Professor |
| Affiliation |
maulana azad medical college |
| Address |
Room No 126
BL Taneja block
Department of medicine
maulana azad medical college
DELHI
110002
India |
| Phone |
|
| Fax |
|
| Email |
spandit01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College
Bahadur Shah Zafar Marg
New Delhi 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad medical College |
| Address |
Bahadur Shah Zafar marg
New Delhi- 110002 |
| 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 |
| Shreyoshee Sarkar |
Maulana Azad Medical College and Lok Nayak Hospital |
Room No 126
B L Taneja Block
Department of medicine
Bahadur Shah Zafar marg
Central
DELHI |
8587860054
drshreyosheesarkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| imstitutional ethics committee maulana azad medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) all patients with diabetes age more than 30 years
2) on treatment for diabetes for more than 5 years
3) regularly attending the medical OPD or Diabetes clinic of LN hospital |
|
| ExclusionCriteria |
| Details |
1) patients suffering from any cognitive or hearing impairment
2) patient already on treatment or diagnosed with a foot ulcer |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Development of Diabetic foot related complications in patients with diabetes |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Development of neuropathy, peripheral vascular disease & other foot related complications. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
15/05/2019 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Diabetes is associated with many serious complications like heart disease , blindness and kidney failure but complications related to the feet although equally devastating have not received due attention of the clinician as well as the researcher. As per the WHO Diabetic foot is defined as the feet of a patient with diabetes with infection, ulceration and / or destruction of the deep tissues. associated with neurological abnormalities and various degrees of peripheral vascular disease in the lower limb. 40 - 60 % of lower limb amputations are associated with diabetes. 85% of diabetes related lower extremity amputations are preceded by a foot ulcer. for prevention of the foot ulcer it is necessary to identify the foot at risk for developing such complications so that by educating the patient about use of necessary foot care precautions the occurrence of these can be reduced . The present study has following aims : 1) To study the prevalence of foot related complications in diabetes 2) to determine the prevalence of Neuropathy & peripheral vascular disease in these cases. 3) To study the practice of foot care in these patients |