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CTRI Number  CTRI/2024/09/073475 [Registered on: 05/09/2024] Trial Registered Prospectively
Last Modified On: 07/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Use of nano polymer gel to cure diabetic foot ulcers 
Scientific Title of Study   Use of nano polymer in wound healing in diabetic foot ulcer 
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 Vaishali Gaikwad 
Designation  Medical Supretendent 
Affiliation  D Y Patil Medical College Hospital and Research Institute 
Address  kadamwadi, Kolhapur

Kolhapur
MAHARASHTRA
416005
India 
Phone  9822379069  
Fax    
Email  drvaishaligaikwad@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Uddhav Patil 
Designation  Associate professor, M.S. Surgery 
Affiliation  D Y Patil Medical College Hospital and Research Institute 
Address  Kadamwadi, Kolhapur, Maharashtra, India, 416005

Kolhapur
MAHARASHTRA
416005
India 
Phone    
Fax    
Email  druddhavpatil@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Karthik Reddy 
Designation  MD student 
Affiliation  D Y Patil Medical College, Kadamwadi, Kolahpur 
Address  Kadamwadi, Kolhapur, Maharashtra

Kolhapur
MAHARASHTRA
416005
India 
Phone  8096634132  
Fax    
Email  karthilucky26382626@gmail.com  
 
Source of Monetary or Material Support  
Dr D Y Patil Education Society, Kadamwadi, Kolhapur, 416005, Maharashtra, India 
 
Primary Sponsor  
Name  Self 
Address  Dr D Y Patil Medical College Hospital and Research Institute, kadamwadi, Kolhapur 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Dr Meghnad Joshi  Central Research Laboratory, 4th floor, Dr D Y Patil Medical College Hospital and Research Institute, kadamwadi, Kolhapur 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Karthik Reddy  Dr D Y Patil Medical College Hospital and FResearch Institute  Department of surgery, Kadamwadi, Kolhapur
Kolhapur
MAHARASHTRA 		 8096634132

karthilucky26382626@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE D Y PATIL MEDICAL COLLEGE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nanopolymer gel  It is a composition of nanopolymers and growth factors which helps in healing diabetic foot ulcers. 
Comparator Agent  Traditional conventional wound dressing  It is a standard wound dressing method used for diabetic foot ulcers, which will be followed. The method uses EUSOL-soaked gauze instead of nanopolymer covering on the site of the wound. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  all patients that come to OPD and IPD with diabetic foot ulcer. The patients with Hb1Ac less than 7.5. Diabetic patients with blood sugar control. Patient must be above 18 years. 
 
ExclusionCriteria 
Details  All the patients who do not follow up in OPD. Patients with diabetic foot ulcer undergoing amputation. Patients with immunocompromised status. Patients with osteomyelitis or gangrenous ulcers. All the patients who do not give consent for the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Wound Healing Rate
2. Incidence of complete wound closure 		 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Safety & Tolerability
Quality of Wound Healing
Assessment of scar
Pain Reduction
Patient Satisfaction & Quality of Life
Cost-effectiveness 		 8 weeks 
 
Target Sample Size   Total Sample Size="27"
Sample Size from India="27" 
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)   01/10/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 (Others) - 

  6. For how long will this data be available start date provided 01-10-2024 and end date provided 01-12-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Nanopolymers enhance wound healing by promoting cell proliferation, reducing infection, and delivering therapeutic agents directly to the wound site. Their nanoscale size allows for better integration with biological tissues, facilitating faster and more effective tissue regeneration and repair. Hence this study is designed for evaluation of the efficacy of formulated nanopolymer for diabetic wound uclers. 
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