| 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
|
|
|
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
|
|
|
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. |