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CTRI Number  CTRI/2026/03/105842 [Registered on: 10/03/2026] Trial Registered Prospectively
Last Modified On: 09/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A Study Comparing Four Different Injection Treatments for Long-Standing Heel Pain (Plantar Fasciitis) and their effectiveness Over 6 Months. 
Scientific Title of Study   Comparative Efficacy of growth Factor Concentrate, platelet-Rich Plasma, steroid, and prolotherapy injections in chronic plantar fasciitis: A Prospective randomized control four-Arm Parallel Trial with 6-Month Follow-Up. 
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 Deepankar Satapathy 
Designation  Assistant Professor, Department Of Orthopaedics 
Affiliation  AIIMS Bibinagar, Hyderabad 
Address  Faculty, Department of Orthopaedics, AIIMS Bibinagar, Hyderabad Metropolitan Region, Telangana, India, 508126

Nalgonda
TELANGANA
508126
India 
Phone  7873777333  
Fax    
Email  dipun86@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Deepankar Satapathy 
Designation  Assistant Professor, Department Of Orthopaedics 
Affiliation  AIIMS Bibinagar, Hyderabad 
Address  Faculty, Department of Orthopaedics, AIIMS Bibinagar, Hyderabad Metropolitan Region, Telangana, India, 508126

Nalgonda
TELANGANA
508126
India 
Phone  7873777333  
Fax    
Email  dipun86@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Deepankar Satapathy 
Designation  Assistant Professor, Department Of Orthopaedics 
Affiliation  AIIMS Bibinagar, Hyderabad 
Address  Faculty, Department of Orthopaedics, AIIMS Bibinagar, Hyderabad Metropolitan Region, Telangana, India, 508126

Nalgonda
TELANGANA
508126
India 
Phone  7873777333  
Fax    
Email  dipun86@gmail.com  
 
Source of Monetary or Material Support  
AIIMS BIBINAGAR, HYDERABAD METROPOLITAN REGION, TELANGANA, INDIA, PIN-508126 
 
Primary Sponsor  
Name  AIIMS BIBINAGAR 
Address  AIIMS Bibinagar,Hyderabad Metropolitan Region,District Yadadri Bhuvanagiri, Telangana, India 508126 
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 Deepankar Satapathy  AIIMS Bibinagar  Room No- 32, Department Of Orthopaedics, AIIMS Bibinagar, Hyderabad Metropolitan Region, District - Yadadri Bhuvanagiri, Telangana, India - 508126
Nalgonda
TELANGANA 		 7873777333

dipun86@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS BBN-IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Patients with plantar fascitis 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Platelet rich plasma, Growth factor concentrate, Prolotherapy  Comparative Efficacy of Growth Factor Concentrate, Platelet rich Plasma, Steroid, and Prolotherapy injections in chronic plantar fasciitis. 
Comparator Agent  Steroid  Triamcinolone Injection 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1)Patients of either gender age between 18 -65 years
2)Patients with plantar fasciitis after failure of conservative treatment for at least 3weeks.
3)Willingness to participate and provision of written informed consent.
 
 
ExclusionCriteria 
Details  1)Age between 18 years and 65 years
2)Patients with history of trauma to affected foot
3)Patients with gross congenital or acquired abnormality of foot
4)Patients with previous injection treatment or surgery to foot
5)Patients with known/existing other inflammatory conditions affecting foot and ankle
6)Vascular insufficiency or neuropathy related to heel pain
7)Known case of bleeding disorders
8)Pregnancy
9)Local infection at the site of procedure
10)History of any malignancy
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in VAS pain score at 1 month, 3 months,6 months from baseline.  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Functional outcomes measured at baseline, 1 month, 3 months, and 6 months   6 MONTHS 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   20/03/2026 
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="2"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dipun86@gmail.com].

  6. For how long will this data be available start date provided 20-02-2026 and end date provided 19-02-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Plantar fasciitis is one of the most common conditions characterized by heel pain, which is usually exacerbated by the first step of the day, especially after standing for a long period of time. This condition arises due to small injuries caused to the plantar fascia, which is a thick band of tissue supporting the arch of the foot. Although there is significant improvement with the help of medication, exercises, and shoe changes, there remain some patients who continue to suffer from pain.

 

Different injections, such as steroid injections, platelet-rich plasma, growth factor concentrate, and dextrose prolotherapy, can be used for the treatment of plantar fasciitis, especially after the failure of conservative treatment options. All of these injections provide relief from plantar fasciitis, although by different mechanisms.

 

Thus, the aim of this study is to compare the efficacy of the above four injections for the treatment of plantar fasciitis, which will be given randomly to 120 patients, who will then be followed for six months for pain relief and improvement of foot function.

 
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