| CTRI Number |
CTRI/2025/09/094224 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
03/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study on the Effectiveness of Topical Minoxidil Dressing in Healing Ischemic Diabetic Foot Wounds. |
|
Scientific Title of Study
|
Wound Healing Efficacy of Topical Minoxidil Dressing in Ischemic Diabetic Foot Wound - A Pilot Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 04, 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 and 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 Mahima Patil |
| Designation |
Clinical research coordinator |
| Affiliation |
Mahalaxmi health care PVT LTD |
| Address |
Subhash road C Ward Laxmipuri Kolhapur
Kolhapur MAHARASHTRA 416002 India |
| Phone |
9890439401 |
| Fax |
|
| Email |
mahimapatil0014@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahalaxmi Healthcare PVT. LTD. Subhash road, C Ward, Laxmipuri, Kolhapur. 416002 |
|
|
Primary Sponsor
|
| Name |
Dr. Amit Burande |
| Address |
Mahalaxmi Healthcare 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. 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 |
| Intervention |
Minoxidil |
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. |
| 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. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
DF wound having ischemic 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 went 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)
|
01/10/2025 |
| 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 - NO
|
|
Brief Summary
|
This study is a randomized, double-blind, interventional pilot study with a sample size of 30 patients, divided into two groups of 15 each.
Topical O2 therapy is added from 1st post-operative day. The wound size will be assessed on the first day and daily thereafter. On the first post-operative dressing (i.e., after 24 hours of surgery or wound cleaning), the assigned dressing protocol will begin.
For dressing, the clinical investigator will be given coded drug-filled syringes as per randomization — containing either Minoxidil or Normal saline (placebo) to be added to the standard dressing protocol. The syringe will be pre-filled and coded to maintain blinding. Neither the patient nor the dressing staff will know the contents.
Dressing Protocol:
1. The wound will be cleaned with normal saline and mopped with sterile gauze.
2. Either interventional drug i.e., Minoxidil (at the required concentration) or Normal saline will be applied as 1 ml per 2–2.5 sq. cm of wound area.
3. It will be applied topically using a 24G blunt needle and syringe.
4. The wound will be covered with sterile gauze and standard dressing.
Dressing will be changed every 24 hours up to 30 days, or until healthy granulation occurs. Wound healing progress will be assessed based on:
1. Size of wound
2. Quality of granulation – pale, pink, or red
3. Presence of exudates – Yes or No, if yes- serious or pus
4. Condition of surrounding skin – edema present or not
Daily progress will be recorded. Once healthy granulation is observed, the date will be noted. If granulation is achieved within 30 days, wound will be prepared for skin grafting or allowed to heal by secondary intention. |