| CTRI Number |
CTRI/2021/01/030653 [Registered on: 21/01/2021] Trial Registered Prospectively |
| Last Modified On: |
20/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Biomarkers in diabetic foot |
|
Scientific Title of Study
|
Serum Biomarkers Procalcitonin and d-dimer in Diabetic Foot
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anup Mohta |
| Designation |
Director Professor |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of Surgery
Lady Hardinge Medical College
Shaheed Bhagat Singh Marg
New Delhi
Central
DELHI
110001
India |
| Phone |
9810478187 |
| Fax |
|
| Email |
mohtaanup@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anup Mohta |
| Designation |
Director Professor |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of Surgery
Lady Hardinge Medical College
Shaheed Bhagat Singh Marg
New Delhi
DELHI
110001
India |
| Phone |
9810478187 |
| Fax |
|
| Email |
mohtaanup@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mansi Bansal |
| Designation |
Postgraduate student |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of Surgery
Lady Hardinge Medical college
Shaheed Bhagat Singh Marg
New Delhi
Central
DELHI
110001
India |
| Phone |
8377069398 |
| Fax |
|
| Email |
mansi251295@gmail.com |
|
|
Source of Monetary or Material Support
|
| Director,
Lady Hardinge Medical College, Shaheed Bhagat Singh Marg,New Delhi-110001 |
|
|
Primary Sponsor
|
| Name |
Lady Hardinge Medical College |
| Address |
Shaheed Bhagat Singh Marg
New Delhi-110001 |
| 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 Anup Mohta |
Sucheta Kriplani Hospital |
Room number 5a
Department of Surgery
Central
DELHI |
9810478187
mohtaanup@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, Lady hardinge Medical college and Associated Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E136||Other specified diabetes mellituswith other specified complications, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All new patients of any sex with 18 to 65 years of age with type 2 diabetes mellitus with diabetic foot ulcer in Lady Hardinge Medical College and associated hospitals. |
|
| ExclusionCriteria |
| Details |
1) Any patient who has received any antibiotics in last seven days.
2) Patients with other known site of infection.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Levels of Biomarkers Procalcitonin and d-dimer among the patients of Diabetic Foot Ulcer
|
Baseline Levels at presentation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Grade of Diabetic Foot Ulcer and it’s correlation with Levels of Biomarkers. |
Baseline At presentation |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
25/01/2021 |
| 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="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)?
Response - NO
|
|
Brief Summary
|
Aim of the study is to evaluate the levels of plasma, procalcitonin and d-dimer in patients with diabetic foot ulcer and correlate the same with the grade of diabetic foot ulcer. After ethics approval and
registration on CTRI, all patients in the age group of 18 to 65 years with
diabetic foot ulcer in Lady Hardinge Medical College and associated
hospitals shall be considered for inclusion. Written informed consent will
be taken from patients. Blood samples will be collected in all patients.
Reports will be evaluated and analysed. All demographic data will be recorded
in a predesigned form.
Blood samples for serum
biomarkers Procalcitonin and D dimer will be collected from all patients taking
all aseptic precautions. Procalcitonin will be processed by spectrophotometric
method by fully automated analysers (Beckman series) by respective kit. D-dimer
will be processed by ELISA method (Enzyme linked immunosorbent assay). All
other relevant investigations will be done as per proforma.
Biomarkers
will be correlated with the different grades of Diabetic Foot Ulcer according
to the Meggitt-Wagner
system of classification. [20]
|
Grade
-0
|
Healed
or pre-ulcerative wound
|
|
Grade-1
|
Superficial
ulcer without penetrating to deeper layers
|
|
Grade-2
|
Deeper
ulcer and reaches tendon, bone or joint capsule
|
|
Grade-3
|
Deeper
tissues are involved and there is abscess formation, osteomyelitis or
tendinitis
|
|
Grade
-4
|
Limited
Gangrene(part of the foot)
|
|
Grade-5
|
Whole
foot gangrene
|
The reports of
serum biomarkers will be collected and correlated.
|