| CTRI Number |
CTRI/2023/09/058013 [Registered on: 26/09/2023] Trial Registered Prospectively |
| Last Modified On: |
23/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Study to assess risk factors leading to Amputation in Diabetic foot patients |
|
Scientific Title of Study
|
Prospective observational study to assess risk factors leading to Amputation in Diabetic foot patients at a tertiary health care center in Belagavi |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Praveen Krishnan |
| Designation |
Post Graduate |
| Affiliation |
KLES Dr Prabhakar Kore Hospital,Belagavi |
| Address |
Jawaharlal Nehru Medical College
KAHER, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9526435718 |
| Fax |
|
| Email |
praveenkrishnan91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishwanath.M.Pattanshetti |
| Designation |
Professor and Vice Principal |
| Affiliation |
KLES Dr Prabhakar Kore Hospital,Belagavi |
| Address |
Department of General Surgery,
Jawaharlal Nehru Medical College
KAHER, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9886175471 |
| Fax |
|
| Email |
drvmshetti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Praveen Krishnan |
| Designation |
Post Graduate |
| Affiliation |
KLES Dr Prabhakar Kore Hospital,Belagavi |
| Address |
Jawaharlal Nehru Medical College
KAHER, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9526435718 |
| Fax |
|
| Email |
praveenkrishnan91@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLEs Dr Prabhakar Kore Hospital, Belagavi |
|
|
Primary Sponsor
|
| Name |
Dr Praveen Krishnan |
| Address |
Jawaharlal Nehru Medical College, KAHER, Nehru Nagar,Belagavi 590010 |
| Type of Sponsor |
Other [self-funded] |
|
|
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 Praveen Krishnan |
KLEs Dr Prabhakar Kore Hospital |
Jawaharlal Nehru Medical College, KAHER, Nehru Nagar, Belagavi 590010
Belgaum
KARNATAKA |
9526435718
praveenkrishnan91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E135||Other specified diabetes mellituswith circulatory complications, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Diabetic patients with written and informed consent, of either sex with foot infections defined as infection of soft tissue in diagnosed case of diabetes mellitus with or without treatment and newly- diagnosed diabetics |
|
| ExclusionCriteria |
| Details |
-Patients with history of previous amputations
-Those suffering from HIV,HBSAg,HCV positivity, psychiatry disorders
-Pregnant and lactating females
-Patients receiving immunosuppressive therapy and radiotherapy |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine risk factors leading to amputation in diabetic foot patients. |
1 Year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To predict lower limb amputation occurrence |
1 Year |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
03/10/2023 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Diabetes
is the most
common underlying cause
of foot ulcers, infection and ischemia, which
are among the most
serious complications of
diabetes, leading to hospitalization and
the most frequent
cause of non- traumatic lower
extremity amputation. Despite well-defined risk factors for diabetic
foot ulcer development, limited data are available as to which factors predict
amputation in a diabetic foot ulcer episode. There are numerous classification systems for
diabetic foot ulcer outcome prediction, but only few studies evaluated their
reliability and validity. Thus, a
single or simplified classification system, which includes the most accurate
predictive factors for amputation, would facilitate decision-making. Therefore, to
predict lower limb amputation occurrence and to
determine the factors
associated with the
risk of amputation in diabetic foot
patients, we conducted this study. |