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CTRI Number  CTRI/2025/07/090972 [Registered on: 16/07/2025] Trial Registered Prospectively
Last Modified On: 15/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Assessment of Vitamin D levels in diabetic foot ulcer patients and its impact on the wound severity. 
Scientific Title of Study   Assessment of Vitamin D levels in patients with Neuropathic Diabetic Foot Ulcers and its correlation with SINBAD score at index presentation 
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 Samridhi Agrawal 
Designation  Junior resident 
Affiliation  Kasturba Medical College, MAHE, Manipal 
Address  Department of General Surgery, 3rd floor, Smt Sharada Madhav Pai OPD, Kasturba Hospital, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8969433943  
Fax    
Email  samridhi.kmcmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr SS Prasad 
Designation  Head of Department and Professor 
Affiliation  Kasturba Medical College, MAHE, Manipal 
Address  Department of General Surgery, 3rd floor, Smt Sharada Madhav Pai OPD, Kasturba Hospital, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8073680789  
Fax    
Email  prasad.ss@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Pavan Madhukar Bhat 
Designation  Assistant Professor at the Department of Surgery  
Affiliation  Kasturba Medical College, MAHE, Manipal 
Address  Department of General Surgery, 3rd floor, Smt Sharada Madhav Pai OPD, Kasturba Hospital, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9731243720  
Fax    
Email  pavan.bhat@manipal.edu  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Samridhi Agrawal 
Address  Department of General Surgery, 3rd Floor, Smt. Sharada Madhav Pai OPD, Kasturba Hospital, Kasturba Hospital,Manipal Udupi KARNATAKA 576104 India  
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 Samridhi Agrawal  Kasturba Hospital, Manipal  Room no: 8, Department of General Surgery, 3rd floor, Smt. Sharada Madhav Pai OPD, Kasturba Hospital, Manipal, Karnataka 576104
Udupi
KARNATAKA 		 8969433943

samridhi.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: E559||Vitamin D deficiency, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Patients aged more than or equal to 18 years with type 2 diabetes mellitus
2. Presence of non-infected neuropathic diabetic foot ulcer
 
 
ExclusionCriteria 
Details  1.Patients with infected diabetic foot ulcers Any two or more of the following)
a)Local swelling or induration
b)Erythema 0.5-2.0 cm around ulcer
c)Local tenderness or pain
d)Local warmth
e)Purulent discharge (thick, opaque to white, or sanguineous)
2. Non-neuropathic ulcers (e.g., venous, arterial, pressure ulcers).
3. Patients with chronic kidney disease (CKD) stage 4 or 5
4. Patients on high-dose vitamin D supplementation (more than 2000 IU/day) in the past 6 months.
5. Patients with other conditions affecting Vitamin D metabolism (e.g., liver disease, hyperparathyroidism, kidney, or malignancy-related)
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Quantifying the Vitamin D deficiency in patients with neuropathic diabetic foot ulcers.  At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
1. Categorizing the patients with Neuropathic DFUs based on vitamin D deficiency, insufficiency, or sufficiency.

2. Analysis of Vitamin D Levels in Different Wound Grades: Division of patients with different SINBAD ulcer grades & analysis of their Vitamin D levels.

3. Determination of Vitamin D Deficiency as Predictive of Ulcer Severity: Study to check whether Vitamin D deficiency acts as a predictor concerning ulcer severity.
 		 At baseline
 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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)   01/08/2025 
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="8"
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 study is a prospective cross-sectional study that will be conducted in the Department of General Surgery, Kasturba Hospital, Manipal. The study will undergo approval by the Institutional Ethics Committee. Informed consent will be taken from the participants at the time of enrolment from all the willing participants in the General Surgery OPD. Study population will include patients with non- infected neuropathic diabetic foot ulcers and relevant history and examination will be conducted to screen for inclusion and exclusion criteria. The ulcer will be examined and scored on the basis of SINBAD system Site, Ischemia, Neuropathy, Bacterial infection, Area, Depth. Serum Vitamin D levels which have been sent by the consultants as a routine protocol will be noted. Blood drawn for other lab investigations will suffice for Vitamin D level assessment also. No additional blood will be drawn separately for Vitamin D level assessment, which is a standard protocol for patients with diabetic neuropathy and reports will be collected from lab viewer. As per prior studies in the Department, the Podiatry Clinic of our Department does Vitamin D levels as a routine practice for all patients with Diabetic Neuropathy, without incurring additional costs. The severity of Vitamin D deficiency will be classified as per US Endocrine Society Classification, compared to the ulcer severity score. Finally, a correlation will be established between Vitamin D and the wound severity score. A p value of <0.05 will be considered statistically significant. The patient will be assessed during the index visit for diabetic foot ulcer and no follow up will be required. 
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