| CTRI Number |
CTRI/2025/02/080861 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
17/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of long term effectiveness of Platelet rich plasma in plantar fasciitis |
|
Scientific Title of Study
|
Evaluation of long term effectiveness of single injection of Platelet rich plasma in plantar fasciitis A Retrospective cum prospective study |
| 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 Pragyesh Jain |
| Designation |
Junior Resident |
| Affiliation |
Teerthankar Mahaveer Medical College and Research Centre Moradabad Uttar Pradesh |
| Address |
Department of Orthopaedics, Teerthankar Mahaveer Medical College and Research Centre,Moradabad, Uttar Pradesh India Pin- 244001
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
7777888963 |
| Fax |
|
| Email |
pragyesh.jain@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manmohan Sharma |
| Designation |
Professor |
| Affiliation |
Teerthankar Mahaveer Medical College and Research Centre Moradabad Uttar Pradesh |
| Address |
Department of Orthopaedics, Teerthankar Mahaveer Medical College and Research Centre,Moradabad, Uttar Pradesh India Pin- 244001
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
|
| Fax |
|
| Email |
manmohan500@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pragyesh Jain |
| Designation |
Junior Resident |
| Affiliation |
Teerthankar Mahaveer Medical College and Research Centre Moradabad Uttar Pradesh |
| Address |
Department of Orthopaedics, Teerthankar Mahaveer Medical College and Research Centre,Moradabad, Uttar Pradesh India Pin- 244001
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
7777888963 |
| Fax |
|
| Email |
pragyesh.jain@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Orthopaedics, Teerthankar Mahaveer Medical College and Research Centre,Moradabad, Uttar Pradesh India Pin- 244001 |
|
|
Primary Sponsor
|
| Name |
Dr Pragyesh Jain |
| Address |
Junior Resident,Department of Orthopaedics, Teerthankar Mahaveer Medical College and Research Centre,Moradabad, Uttar Pradesh India Pin- 244001 |
| 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 Pragyesh Jain |
Teerthankar Mahaveer Medical College and Research Centre |
Department of Orthopaedics, Teerthankar Mahaveer Medical College and Research Centre,Moradabad, Uttar Pradesh India Pin- 244001
Moradabad
UTTAR PRADESH |
7777888963
pragyesh.jain@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Teerthankar Mahaveer UniversitIy Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Platelet Rich plasma |
Platelet Rich plasma is composed of indigenous blood products centrifused to aggregate platelets and growth factors, the Total duration from collection of blood to making of platelet Rich plasma and injection into the subject is 30 mins.
Dose is 2 Ml of platelet Rich plasma, Frequency is single injection and route of administration is intralesional that is on the point of maximum tenderness over medial calcaneal area |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
All adult patients clinically diagnosed with plantar fasciitis of foot |
|
| ExclusionCriteria |
| Details |
Less than 18 years of age
Any injection site skin lesions
Severe infection
Bleeding disorder
Malignancy
Pregnancy
Previous surgery |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To identify and treat cases of plantar fasciitis with single intraarticular injection of platelet Rich plasma |
Outcomes will be assessed at 1 month,2months,3 months, 6 months and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the long term effectiveness in terms of VAS & Roles & maudsley score |
Outcomes will be assessed at 1 month,2months,3 months, 6 months & 12 months |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
28/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
28/02/2025 |
| 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)
|
Open to Recruitment |
| 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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - TMMC and RC
- For how long will this data be available start date provided 21-02-2025 and end date provided 21-02-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Patient with plantar fasciitis Coming to OPD of TMMC and RC will be recruited and will be given injection of PRP after proper consent and outcomes will be followed up upto a period of 1 year |