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CTRI Number  CTRI/2025/09/095211 [Registered on: 22/09/2025] Trial Registered Prospectively
Last Modified On: 20/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Chlorhexidine Wash Versus Povidone Iodine Wash on Wound Healing in Patients with Diabetic Foot Ulcers 
Scientific Title of Study   A Randomized Controlled Trial Comparing Chlorhexidine Soap Versus Povidone Iodine Wash in the Wound Management of Diabetic Foot Ulcers 
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 Dennis P Jose 
Designation  Orthopedic Consultant 
Affiliation  Lakeshore Hospital, Cochin 
Address  Division of Foot and Ankle and Podiatry VPS Lakeshore hospital Kochi India

Ernakulam
KERALA
682040
India 
Phone  9895283937  
Fax    
Email  drdennisp@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dennis P Jose 
Designation  Orthopedic Consultant 
Affiliation  Lakeshore Hospital, Cochin 
Address  Division of Foot and Ankle and Podiatry VPS Lakeshore hospital Kochi India

Ernakulam
KERALA
682040
India 
Phone  9895283937  
Fax    
Email  drdennisp@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Dennis P Jose 
Designation  Orthopedic Consultant 
Affiliation  Lakeshore Hospital, Cochin 
Address  Division of Foot and Ankle and Podiatry VPS Lakeshore hospital Kochi India

Ernakulam
KERALA
682040
India 
Phone  9895283937  
Fax    
Email  drdennisp@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Dennis P Jose  
Address  Division of Foot and Ankle and Podiatry VPS Lakeshore hospital Kochi India 
Type of Sponsor  Other [SELF] 
 
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 Dennis P Jose  Lakeshore Hospital, Kochi  Room No 3037, Foot and ankle department, VPS Lakeshore hospital Kochi India
Ernakulam
KERALA 		 9895283937

drdennisp@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Lakeshore Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Chlorhexidine Gluconate Solution I.P 4% w/v  The intervention consists of wound cleansing with a chlorhexidine containing soap applied at every dressing change once in 3 days for a period of three weeks. 
Comparator Agent  Povidone Iodine Wash   Participants allocated to the comparator group will receive povidone iodine wash for wound cleansing at the same frequency and duration as for intervention group. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Presence of Meggitt Wagner grade 1 to 4 diabetic foot ulcer 
 
ExclusionCriteria 
Details  Use of other topical antiseptics or treatments outside protocol
Known allergy to chlorhexidine or povidone iodine
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Mean reduction in Bates Jensen wound assessment tool (BWAT) score  Before intervention and after 3 weeks of intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Time to complete healing  1 month 
Incidence of adverse effects  1 month 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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)   20/10/2025 
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="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 - 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 - 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 - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drdennisp@gmail.com].

  6. For how long will this data be available start date provided 13-12-2029 and end date provided 19-12-2029?
    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  

Diabetic foot ulcers are a common complication of diabetes and a major cause of hospital admissions and amputations. Effective wound cleansing is critical in their management. Two commonly used antiseptics are chlorhexidine and povidone iodine, but there is limited comparative evidence on their effectiveness in wound healing in diabetic foot ulcers.

This single-centre, randomised controlled trial will compare chlorhexidine-containing soap versus povidone iodine wash for wound cleansing in patients with diabetic foot ulcers. Eligible adult patients with Wagner grade 1–4 ulcers will be randomised into two groups. Wound status will be assessed at baseline and after 3 weeks using the Bates-Jensen Wound Assessment Tool (BWAT) by an independent, blinded observer.

The primary outcome is the mean reduction in BWAT score. Secondary outcomes include time to complete healing and incidence of adverse effects.

A total of 66 patients (33 per group) will be included. Standard diabetic foot care, including debridement, offloading, antibiotics if required, and glycaemic control, will be provided to all participants.

This study aims to provide evidence on which antiseptic wash—chlorhexidine or povidone iodine—is more effective for wound healing in diabetic foot ulcers.

 
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