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CTRI Number  CTRI/2025/07/090021 [Registered on: 02/07/2025] Trial Registered Prospectively
Last Modified On: 30/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Comparing Growth factor concentrates with platelet rich plasma in conditions of Plantar Fasciitis that doesn’t resolve by non invasive managements 
Scientific Title of Study   Comparative study between Growth Factor Concentrate, Platelet Rich Plasma and placebo on the pain and Function in patients with chronic plantar fasciitis in a tertiary care centre ; A triple blinded Randomised Control 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  Ananthakrishna J 
Designation  Junior Resident  
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room no 711, hostel no 18 , AIIMS Masjid moth campus, AIIMS New Delhi
Room no 19, Department of PM&R , teaching block AIIMS 110029
South
DELHI
110029
India 
Phone  7902859071  
Fax    
Email  kazhak5108akj@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ananthakrishna J 
Designation  Junior Resident  
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room no 711, hostel no 18 , AIIMS Masjid moth campus, AIIMS New Delhi
Room no 19, Department of PM&R , teaching block AIIMS 110029
South
DELHI
110029
India 
Phone  7902859071  
Fax    
Email  kazhak5108akj@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ananthakrishna J 
Designation  Junior Resident  
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room no 711, hostel no 18 , AIIMS Masjid moth campus, AIIMS New Delhi
Room no 19, Department of PM&R , teaching block AIIMS 110029
South
DELHI
110029
India 
Phone  7902859071  
Fax    
Email  kazhak5108akj@gmail.com  
 
Source of Monetary or Material Support  
PG research grant  
 
Primary Sponsor  
Name  PG Research grant 
Address  Research Section , 1st floor near CMET AIIMS New Delhi 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ananthakrishna J  AIIMS Delhi  Room no 19 ,Dept of PM&R Ground floor teaching block
South
DELHI 		 7902859071

kazhak5108akj@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH ALL INDIA INSTITUTE OF MEDICAL SCIENCES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M722||Plantar fascial fibromatosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Injection Growth factor concentrate  Injection autologous Growth factor concentrate will be injected using a peppering technique, involving 3-4 penetrations of the fascia but only a single skin portal 
Comparator Agent  Normal saline (placebo)  Injection of 1.5ml of 3% normal saline will be injected using a peppering technique, involving 3-4 penetrations of the fascia but only a single skin portal 
Intervention  Platelet Rich Plasma  Injection of 1.5 ml of autologous PRP will be injected using a peppering technique, involving 3-4 penetrations of the fascia but only a single skin portal. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patient with unilateral or bilateral heel pain diagnosed to have Chronic Plantar fasciitis using either of the two following diagnostic criterias 2.1) Clinical criteria 1) Patients describing heel pain that is worse in the morning or after a period of inactivity.
2)Patients complaining of heel pain initially lessens out and then gradually increasing towards the end of day.
3)Patient has a local point tenderness near the origin of the plantar fascia at the medial tuberosity of the calcaneum.
2.2) USG criteria: Ultrasound examination showing plantar fascia thickness greater than or equal to 4 mm or
difference in plantar fascia thickness greater than or equal to 1 mm in symptomatic heel in comparison to
asymptomatic heel at inferior border of the calcaneus.
3. Patient have significant pain(VAS score greater than 3) even after conservative managements for more than 3 weeks.
4. In bilateral cases, foot with more clinical severity will be taken into the study.
5. Patient has to be literate (able to read and understand) in either English or Hindi language 
 
ExclusionCriteria 
Details  Received local steroid injection within 6 months.
2. History of anemia (Hb lesser than 10g/dL) or bleeding disorders.
3. Previous surgery for plantar fasciitis.
4. Achilles tendon pathology.
5. Diagnosed case of local malignancy.
6. Diagnosed case of rheumatological diseases.
7. Patients on anticoagulation therapy.
8. Diagnosis of vascular insufficiency or neuropathy related heel pain (radiculopathy, tarsal tunnel syndrome) and other causes of heel pain.
9. Any local trauma or infection.
10. Anatomical deformities of foot like pes planus and pes cavus.
11. Patient with uncontrolled diabetes and hypertension.
12. Patient not willing for the participation in the study 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcome measure will be the difference in pain from the baseline in VAS scales assessed at 2 weeks, 4 weeks, 8 weeks and 12 weeks from the date of intervention  The primary outcome measure will be the difference in pain from the baseline in VAS scales assessed at 2 weeks, 4 weeks, 8 weeks and 12 weeks from the date of intervention 
 
Secondary Outcome  
Outcome  TimePoints 
1) Difference in pain and functional limitation from the baseline in the Foot function Index scale to be analyzed at 2 weeks, 4 weeks, 8 weeks and 12 weeks from the date of intervention  1) Difference in pain and functional limitation from the baseline in the Foot function Index scale to be analyzed at 2 weeks, 4 weeks, 8 weeks and 12 weeks from the date of intervention 
2) The difference in plantar fascia thickness from the baseline measured using ultrasound calipers at 12 weeks post intervention.  2) The difference in plantar fascia thickness from the baseline measured using ultrasound calipers at 12 weeks post intervention. 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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 
Date of First Enrollment (India)   15/07/2025 
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)   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 will be done in AIIMS on an Outpatient basis and won’t be recruiting people from any other centres. This study would involve multiple follow up visits at 2,4,8,12 weeks after the injections too. 
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