| CTRI Number |
CTRI/2025/09/094318 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
27/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to see if using Platelet-Rich Fibrin (PRF) helps heal long standing non-healing wounds in patients |
|
Scientific Title of Study
|
Role and Efficacy of Platelet-Rich Fibrin (PRF) in Management of Chronic Non-Healing Wounds |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amrita More |
| Designation |
Associate professor |
| Affiliation |
Vardhman mahavir medical college and safdarjung hospital |
| Address |
Department of Burns, Plastic and Maxillofacial Surgery, Safdarjung Hospital,
Aurobindo Marg, Ansari Nagar West
South
DELHI
110029
India |
| Phone |
9074037720 |
| Fax |
|
| Email |
dr.amrita47@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amrita More |
| Designation |
Associate professor |
| Affiliation |
Vardhman mahavir medical college and safdarjung hospital |
| Address |
Department of Burns, Plastic and Maxillofacial Surgery, Safdarjung Hospital,
Aurobindo Marg, Ansari Nagar West
South
DELHI
110029
India |
| Phone |
9074037720 |
| Fax |
|
| Email |
dr.amrita47@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amrita More |
| Designation |
Associate professor |
| Affiliation |
Vardhman mahavir medical college and safdarjung hospital |
| Address |
Department of Burns, Plastic and Maxillofacial Surgery, Safdarjung Hospital,
Aurobindo Marg, Ansari Nagar West
South
DELHI
110029
India |
| Phone |
9074037720 |
| Fax |
|
| Email |
dr.amrita47@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Vardhman mahavir medical college and safdarjung hospital, delhi |
| Address |
Aurobindo marg, Ansari nagar west, delhi 110029 |
| Type of Sponsor |
Government medical college |
|
|
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 amrita mandal |
Vardhman mahavir medical college and safdarjung hospital |
Ansari Nagar Wes Aurobindo marg 110029, new delhi
South
DELHI |
9074037720
dr.amrita47@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| vardhman mahavir medical college and safdarjung hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L974||Non-pressure chronic ulcer of heeland midfoot, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
Platelet-Rich Fibrin |
Platelet-Rich Fibrin (PRF)is prepared by procuring around 10 to 30 ml of blood depending on the wound size in a sterile vial and the vial is centrifuged at 3000 Rounds per minute for 10 minutes. Each 5 ml vial will form a gel of size approximately 3 cm X 1 cm which will be applied on the wound. The Wound will be assessed weekly. This process is repeated weekly for a maximum of 8 sessions. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of age between 18 and 60 years with wounds that have persisted for atleast 4 weeks of various etiologies, such as diabetic ulcers, venous ulcers, pressure sores, or ischemic ulcers, small post burn wounds without significant improvement despite standard care.
2. Patients with stable systemic conditions allowing wound treatment.
3. Patients who have not responded to at least one standard wound care protocol prior to the intervention
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • To assess the effectiveness of PRF in reducing wound size and accelerating healing time in chronic non-healing wounds. |
Weekly for 9 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • To evaluate the impact of PRF on wound bed preparation, including granulation tissue formation and re-epithelialization. |
Weekly for 9 weeks |
| • To analyse the role of PRF in reducing wound-associated complications such as infection and exudate. |
Weekly for 9 weeks |
| • To assess patient satisfaction and quality of life after PRF treatment |
At end of treatment |
| • To document any adverse effects or challenges encountered during the use of PRF |
throughout the course of treatment |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
15/09/2025 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - dr.amrita47@gmail.com (TO MAIL FOR ACCESS)
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Aims
To evaluate the role and efficacy of Platelet-Rich Fibrin (PRF) in promoting
the healing of chronic non-healing wounds and improving patient outcomes
through our clinical experience.
Objectives
- Primary Objective
- To assess the
effectiveness of PRF in reducing wound size and accelerating healing time
in chronic non-healing wounds.
- Secondary Objectives
- To evaluate the
impact of PRF on wound bed preparation, including granulation tissue
formation and re-epithelialization.
- To analyse the role
of PRF in reducing wound-associated complications such as infection and exudate.
- To assess patient
satisfaction and quality of life after PRF treatment.
- To document any
adverse effects or challenges encountered during the use of PRF.
RESEARCH QUESTION Is Platelet Rich Fibrin in management of chronic non healing
wounds safe and
beneficial? HYPOTHESIS Platelet Rich Fibrin in management of chronic non healing
wounds is safe and beneficial.
|