| CTRI Number |
CTRI/2024/08/072238 [Registered on: 09/08/2024] Trial Registered Prospectively |
| Last Modified On: |
30/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Other |
|
Public Title of Study
|
Advantages of GFC over conservative treatment in planter fasciitis |
|
Scientific Title of Study
|
Efficacy of Autologous Growth Factor Concentrate (GFC) Infiltrate Vs Conventional Treatment in Planter Fasciitis: A Randomised Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aman baijal |
| Designation |
Junior resident |
| Affiliation |
uttar pradesh university of medical sciencesSaifai |
| Address |
Department of orthopaedic,Uttar Pradesh university of medical sciences ,Saifai,Etawah,UP
Etawah
UTTAR PRADESH
206130
India |
| Phone |
7060240378 |
| Fax |
|
| Email |
amanbaijal111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SUNIL KUMAR |
| Designation |
PROFESSOR |
| Affiliation |
Uttar pradesh university of medical sciences,Saifai |
| Address |
Department of orthopaedic,Uttar pradesh university of medical sciences,Saifai,Etawah,UP
UTTAR PRADESH
206130
India |
| Phone |
7060240378 |
| Fax |
|
| Email |
sksrimsnr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aman baijal |
| Designation |
Junior resident |
| Affiliation |
UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES |
| Address |
Department of orthopaedic,UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES ,Saifai,Etawah,UP
UTTAR PRADESH
206130
India |
| Phone |
7060240378 |
| Fax |
|
| Email |
amanbaijal111@gmail.com |
|
|
Source of Monetary or Material Support
|
| Uttar Pradesh university of medical sciences,saifai,etawah,uttar pradesh pin code 206130 |
|
|
Primary Sponsor
|
| Name |
Uttar Pradesh University of Medical Sciences |
| Address |
Uttar Pradesh University of Medical Sciences,Etawah,Uttar Pradesh,Pin code-206130 |
| 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 |
| Aman baijal |
Uttar Pradesh University of Medical Sciences |
Department of OrthopaedicsUttar Pradesh University of Medical Sciences
Etawah
UTTAR PRADESH |
7060240378
amanbaijal111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Uttar Pradesh university of medical sciences saifai UP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional treatment |
Soft sleepers,contrast bathing etc are advised to patients for around 6 months |
| Intervention |
GFC injection |
At the site of planter fasciitis(heel) growth factor concentrate is given around 4 ml intramuscular stat .follow up will be done at 0,1 and 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
-Clinically diagnosed case of plantar fasciitis
-Unilateral or Bilateral pain/symptoms(plantar fasciitis) |
|
| ExclusionCriteria |
| Details |
- Acute traumatic plantar fasciitis/heel pain
-Patients with nerve related pathologies, muscular dystrophy
- Patients with heel pain due to any rheumatological disease like rheumatoid arthritis, gout
- Pregnant ladies and breast feeding mothers
-Patients having metastatic disease, local infection
-Patients who are on anti-platelet therapy
-Patients who have taken injection of steroids/PRP
-Heel pain due to old malunited heel fractures, having flat foot |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of GFC in reducing pain |
outcome will be assessed at the end of 6 months from intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of GFC vs conventional treatment in planter fasciitis |
At the end of the study |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/08/2024 |
| 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)
|
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
|
The study aims To compare the Effectiveness and utility of Growth Factor Concentrate (GFC) over conventional treatment in Planter Fasciitis The purpose if the trial is to compare functional outcome and pain improvement of GFC over conservative treatment in planter fasciitis
|