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CTRI Number  CTRI/2025/01/079660 [Registered on: 28/01/2025] Trial Registered Prospectively
Last Modified On: 04/06/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Wound Healing Effect of Papaverine in Ischemic Diabetic Foot Wound 
Scientific Title of Study   Wound Healing Efficacy of Topical Papaverine Dressing in Ischemic Diabetic Foot Wound - A Pilot Study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
03,version 1.0 dated 28/12/2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Amit Burande 
Designation  Consultant orthopaedic & diabetic foot surgeon 
Affiliation  Mahalaxmi health care PVT LTD 
Address  Subhash road c ward Laxmipuri Kolhapur

Kolhapur
MAHARASHTRA
416002
India 
Phone  9822517012  
Fax    
Email  burandeamit@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Meeta Burande 
Designation  Consultant diabetologist 
Affiliation  Mahalaxmi health care PVT LTD 
Address  Subhash road c ward Laxmipuri Kolhapur

Kolhapur
MAHARASHTRA
416002
India 
Phone  9850937261  
Fax    
Email  drmeetamit@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Miss Siddhi Powar 
Designation  Clinical research coordinator 
Affiliation  Mahalaxmi health care PVT LTD 
Address  Subhash road c ward Laxmipuri Kolhapur

Kolhapur
MAHARASHTRA
416002
India 
Phone  7620405445  
Fax    
Email  siddhipowar17@gmail.com  
 
Source of Monetary or Material Support  
Mahalaxmi Health Care PVT LTD Subhash road, c ward, Laxmipuri, Kolhapur, India. 416002 
 
Primary Sponsor  
Name  Dr. Amit Burande 
Address  Mahalaxmi Health Care PVT LTD. Subhash road, C ward, Laxmipuri, Kolhapur. 416002 
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 Amit Burande  Surya hospital  Department of Clinical Research, Diabetic Foot Indoor patients at ICU, SICU, Room & Ward. Subhash road, c ward, Laxmipuri Kolhapur. 416002
Kolhapur
MAHARASHTRA 
9822517012

burandeamit@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Mahalaxmi Health Care PVT LTD Institutional 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 
Comparator Agent  Normal saline  30mg/ml will be applied as 1ml per 2-2.5 sq. cm of wound area. It will be applied as topical spray on the wound with the help of 24 G blunt needle and syringe. Next dressing will be done after 24 hours and daily up to 30 days or till healthy granulation occurs. Standard dressing protocol would be given to all patients. 
Intervention  Papaverine  30mg/ml will be applied as 1ml per 2-2.5 sq. cm of wound area. It will be applied as topical spray on the wound with the help of 24 G blunt needle and syringe. Next dressing will be done after 24 hours and daily up to 30 days or till healthy granulation occurs. Standard dressing protocol would be given to all patients. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  DF wound having ischemia on clinical and diagnostic assessment having any of the following:
1. Pale granulation.
2. Moderate to severe obstruction in blood flow supplying the wound on Color Doppler OR Angiography OR clinical examination OR ABI (any one of them)
3.Despite of having critical limb ischemia patient has not undergone vascular intervention for various reasons by informed choice. 
 
ExclusionCriteria 
Details  1. Patient not willing for consent.
2. Patient underwent Angioplasty.
3. Patient having good blood supply to wound. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Healthy granulation of wound  30 days 
 
Secondary Outcome  
Outcome  TimePoints 
Skin grafting  30 days  
Healed by secondary intention  30 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   10/02/2025 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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  

This study is randomized double blind, interventional pilot study with sample size 30 patients having 15 patients in each group.

Topical O2 therapy is added from 1st post-operative day. The size of the wound would be assessed on first day and daily. On first post-operative dressing i.e., after 24 hours of surgery the dressing protocol will be initiated.

For dressing, the clinical investigator will be given coded drug filled syringe as per the sequential allocation of coded syringe to add on standard dressing protocol. Syringe will be filled either with papaverine or normal saline as per randomization sequence. Patient has been given normal saline or papaverine will not be known to any person who is doing dressing or collecting the wound assessment data.

Dressing protocol:

1. The wound will be clean with normal saline and mopped with sterile gauze.

2. Either interventional drug i.e. Papaverine injection in concentration of 30mg/ml or Normal saline as placebo will be applied as 1ml per 2-2.5 sq. cm of wound area.

3. It will be applied as topical spray on the wound with the help of 24 G blunt needle and syringe. 

4. Wound will be covered with sterile gauze and standard dressing covering.

Next dressing will be done after 24 hours and daily up to 30 days or till healthy granulation occurs with documentation of wound healing parameters in terms of –

1. Size of wound

2. Quality of granulation – pale or pink or red

3. Exudates – yes or no, If yes - serous or pus

4. Surrounding skin – edema present or not

Wound will be observed for healthy granulation for 30 days. A day when healthy granulation occurs will be noted. During 30 days if healthy granulation occurs wound is prepared for skin grafting or healed by secondary intention.

 
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