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CTRI Number  CTRI/2026/01/100139 [Registered on: 01/01/2026] Trial Registered Prospectively
Last Modified On: 26/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to find out whether a special wound-cleaning solution Diperochloric solution (DPOCL) works better than usual dressings in healing long-lasting foot wounds in people with diabetes. 
Scientific Title of Study   Comparison Of Conventional Dressing With Dressing By Diperochloric Solution(Dpocl) For The Healing Of Chronic Diabetic Neuropathic Ulcer – A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vanshika A Baria 
Designation  surgery resident 
Affiliation  GMC bhavnagar 
Address  Department of General Surgery, Sir T General Hospital & Government Medical College,Bhavnagar
Akashganga society , Godi road, Dahod, Gujarat
Bhavnagar
GUJARAT
364001
India 
Phone  8160715491  
Fax    
Email  vanshikabaria@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vanshika A Baria 
Designation  surgery resident 
Affiliation  GMC bhavnagar 
Address  Department of General Surgery, Sir T General Hospital & Government Medical College,Bhavnagar
Akashganga society , Godi road, Dahod, Gujarat
Bhavnagar
GUJARAT
389151
India 
Phone  8160715491  
Fax    
Email  vanshikabaria@gmail.com  
 
Details of Contact Person
Public Query  
Name  Rajan B Somani 
Designation  Additional Professor 
Affiliation  GMC bhavnagar 
Address  Department of General Surgery, Sir T General Hospital & Government Medical College,Bhavnagar

Bhavnagar
GUJARAT
364001
India 
Phone  9825572796  
Fax    
Email  somanirajan@gmail.com  
 
Source of Monetary or Material Support  
Sir T General Hospital Bhavnagar 
 
Primary Sponsor  
Name  Goverment Medical College Bhavnagar 
Address  Sir T General Hospital & Government Medical College, Bhavnagar Gujarat India 364001 
Type of Sponsor  Government 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 
Vanshika A Baria  Sir T General Hospital   Department of General Surgery, Government Medical College, Bhavnagar
Bhavnagar
GUJARAT 		 08160715491

vanshikabaria@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICSCOMMITTEEGOVERNMENTMEDICALCOLLEGEBHAVNAGAR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  diperoxochloric solution  dressing should be done by diperoxochloric solution in comparator group 
Intervention  sodium chloride 0.9%  dressing should be done by sodium chloride 0.9% in control group 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  patient with chronic diabetic foot ulcer of less than 5 cm of wagner classification 1-2 
 
ExclusionCriteria 
Details  Pregnant women and lactational
women 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To study the time required for complete wound closure of chronic diabetic neuropathic ulcer  4weeks 6weeks 8weeks 10weeks 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   06/01/2026 
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 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  

AIM: 

TO COMPARE THE OUTCOME OF CONVENTIONAL DRESSING WITH THE DRESSING BY DIPEREXOCHLORIC (DPOCL) SOLUTION FOR THE HEALING OF CHRONIC DIABETIC NEUROPATHIC ULCER

OBJECTIVES:

1.To assess the time required for complete wound closure of chronic diabetic neuropathic ulcer.
2.To assess the time required for initial response to the treatment of chronic diabetic neuropathic ulcer.

WHY THIS STUDY IS ESSENTIAL?
•DIABETIC FOOT ULCER(DFU) ,A CRITICAL COMPLICATION OF DIABETES MELLITUS IS ASSOCIATED WITH HIGH RISK OF INFECTION ,GANGRENE,AMPUTATION AND DEATH
•
•WOUND DRESSING FORM AN INTEGRAL PART OF THE DFU MANAGEMENT,AND DPOCL CAN BE USED FOR FASTER WOUND HEALING,WOUND CLOSURE,SURFACE AREA REDUCTION AND IMPROVEMENT IN CLINICAL STATUS

•Study Design: RANDOMISED CONTROL TRIAL
•Study Setting (Site): Department of General Surgery , Sir T hospital, Bhavnagar.
•Intervention (if any): yes


•INCLUSION CRITERIA

1. Patient with diabetic chronic(>4WEEKS) Neuropathic   ulcer

age group >18 Years

2. Ulcer size <5cm

3.wagner classification 1-2

• EXCLUSION CRITERIA

1. Pregnant female

2 Lactation


MATERIALS AND METHODS

STUDY DESIGN:

-RANDOMISED CONTROL TRIAL

SOURCE OF DATA

-Patients of diabetic neuropathic ulcer admitted to surgery department or attending surgery OPD of SIR T HOSPITAL

•SAMPLE SIZE-
•at 95% confidence intervals ant 80% power final sample size is 72, 36 in each group


•Study Design: A randomized control trial study.
•Study Population: Patients with diabetic , neuropathic ulcer admitted in wards of General Surgery Department, Sir T Hospital Bhavnagar, Government Medical College, Bhavnagar.
•Brief about study procedures:
ØStudy design: A Randomised control trial
ØStudy duration: 6 Months.
ØInformed written consent from the patient, this randomized controlled clinical study will be carried out on indoor patients in the Department of General Surgery, Government Medical College, Bhavnagar, Gujarat, India.
ØAfter thorough clinical evaluation, patients will be included or excluded according to the Inclusion and Exclusion Criteria.
ØThe study will be conducted my making 2 study groups by paper - chit method
ØSTUDY GROUP A-TEST(DRESSING WITH DPOCL),AND GROUP B-DRESSING WITH NORMAL SALINE
Ø•REGULAR DRESSING WITH DPOCL OR NORMAL SALINE WILL BE APPLIED FOR TREATMENT PERIOD OF 10 WEEKS,
ØThe following data will be collected and recorded from the patient on their first visit:

1. Patients’ General Information including name, age, sex, MRD number.

2. Diagnosis and Treatment Data will be recorded in the form of:

• Duration of diagnosis of wounds over body

• Total duration of medications/therapy taken

• Duration since ulcer formation

• Changes in the size of ulcer before beginning the study adherence to   treatment.

ØThe following data will be collected from the patients in follow up dressing:

§Date based dressing records will be done in written, graphical and to look for changes in size, edge, margin and floor of ulcer.
§Random blood sugar level, frequency of dressing in the past week, adherence to treatment, culture and sensitivity of the wound

•ANALYSIS OF THE WOUND WILL BE DONE AT 4-6 WEEK,6-8WEEK,8-10 WEEK
AND WOUND WILL BE ASSESSED FOR COMPLETE WOUND CLOSURE AND REDUCTION IN WOUND SURFACE AREA BY MEASURING THE SIZE OF WOUND WITH MEASURE TAPE AND VISUAL ASSESSMENT BY TAKING PHOTOGRAPHS


 

METHODOLOGY

    • PARTICIPANT SELECTION BASED ON INCLUSION AND EXCLUSION CRITERIA WITH WRITTEN AND INFORMED CONSENT
•SIMPLE METHOD OF GENERATING RANDOM SEQUENCE BY THE PAPER CHIT METHOD
•WITH STUDY GROUP A-TEST(DRESSING WITH DPOCL),AND GROUP B-DRESSING WITH NORMAL SALINE

•REGULAR DRESSING WITH DPOCL OR NORMAL SALINE WILL BE APPLIED FOR TREATMENT PERIOD OF 10 WEEKS,

•ANALYSIS OF THE WOUND WILL BE DONE AT 4-6 WEEK,6-8WEEK,8-10 WEEK
•AND WOUND WILL BE ASSESSED FOR COMPLETE WOUND CLOSURE AND REDUCTION IN WOUND SURFACE AREA BY MEASURING THE SIZE OF WOUND WITH MEASURE TAPE AND VISUAL ASSESSMENT BY TAKING PHOTOGRAPHS

•TABULATION OF DATA IN EXCEL SHEET 
•ANALYSIS OF DATA   
•TO COMPARE THE COMPLETE WOUND CLOSURE BETWEEN BOTH GROUPS


Risk & Benefits
ØThere are direct benefits to study participants. Diperoxochloric acid (DPOCL, an adduct of peroxochlorate and chlorite) is a bi-functional antibacterial molecule, which is proliferative in Medical Research Council cell strain (MRC)-5 fibroblast cell-lines. It is believed to trigger ulcer healing by disinfecting the wound ground, diminishing germ load to nearly zero within 2 hours and stimulating the fibroblasts. leading to faster wound healing and wound closure and improvement in clinical status
ØSociety will be benefited by reducing hospital stay duration.
ØThere is no physical, psychological or social risk to study participants.




 
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