FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/04/108178 [Registered on: 12/04/2026] Trial Registered Prospectively
Last Modified On: 28/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Evaluating four classification systems of diabetic foot ulcers to predict amputation risk 
Scientific Title of Study   Comparative analysis of four systems of classification of diabetic foot ulcers in predicting lower extremity amputation (LEA) rate 
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 Poojary Yasha Babu 
Designation  Postgraduate 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of General Surgery, Kasturba Medical College, Eshwar Nagar,
Manipal, Udupi Karnataka
Udupi
KARNATAKA
576104
India 
Phone  8296468576  
Fax    
Email  poojary.kmcmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Bharath S V 
Designation  Professor and Thesis Guide 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of General Surgery, Kasturba Medical College, Eshwar Nagar,
Manipal, Udupi Karnataka
Udupi
KARNATAKA
576104
India 
Phone  8296468576  
Fax    
Email  bharath.sv@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Poojary Yasha Babu 
Designation  Postgraduate 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of General Surgery, Kasturba Medical College, Eshwar Nagar,
Manipal, Udupi Karnataka
Udupi
KARNATAKA
576104
India 
Phone  8296468576  
Fax    
Email  poojary.kmcmpl2024@learner.manipal.edu  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Kasturba Medical College Manipal 
Address  Kasturba Medical College, Eshwar Nagar, Manipal Udupi, Karnataka-576104 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Poojary Yasha Babu  Kasturba Hospital, Manipal  Department of General Surgery, Kasturba Hospital, Madhav Nagar, Manipal, Udupi-576104
Udupi
KARNATAKA 		 8296468576

poojary.kmcmpl2024@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba medical college and Kasturba hospital Institutional Ethics Committee - 2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E08-E13||Diabetes mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1. Adult patients diagnosed with Type 1 or Type 2 Diabetes Mellitus with diabetic foot ulcer, visiting the Surgery OPD or admitted in wards
2. All diabetic foot ulcers irrespective of duration and presence of infection, peripheral vascular disease, diabetic neuropathy
3. Ability to consent and participate in the study 
 
ExclusionCriteria 
Details  1. Diabetic individuals with ulcers above ankle
2. Patients with prior major lower extremity amputation, those with pre-existing below knee or above knee amputations
3. Participants who are lost to follow up or whose outcomes are unknown
4. Patients with cognitive impairments who cannot provide informed consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Number of patients that undergo lower extremity amputation (LEA)-major or minor and their correlation with the grades given under each classification system
 		 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To compare clinical utility of each system in predicting other outcomes related to morbidity such as non-healing & need for debridement, sepsis, need for ICU stay & mortality  4 weeks 
 
Target Sample Size   Total Sample Size="108"
Sample Size from India="108" 
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)   22/04/2026 
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 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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [poojary.kmcmpl2024@lkearner.manipal.edu].

  6. For how long will this data be available start date provided 23-08-2027 and end date provided 23-12-2027?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Patients with diabetic foot ulcer who meet the eligibility criteria presenting to the Kasturba Hospital Surgery OPD or admitted as in-patients will be recruited into the study. Detailed clinical examination will be performed and data will be collected using a proforma, including patient demographic details, history of diabetes, ulcer history and clinical examination findings. Baseline characteristics of the ulcer will be recorded. On the basis of the clinical examination, the ulcer will be staged under the four classifications intended to be compared. The patient will be followed up after one month telephonically to assess the outcome of each case, primarily in the form of lower extremity amputation and secondarily as need for debridement, development of sepsis and need for ICU stay. 
Close