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CTRI Number  CTRI/2025/11/097656 [Registered on: 18/11/2025] Trial Registered Prospectively
Last Modified On: 14/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two pain mitigation strategies of a minimally invasive surgical technique in patients suffering from plantar fasciitis, which is refractory to medical management 
Scientific Title of Study   Comparison of super selective transcatheter arterial embolization versus non-selective ultrasound guided embolization technique in plantar fascitis refractory to conservative management: an open-label pilot 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  Akshit Kumar 
Designation  Senior resident 
Affiliation  All India Institue of Medical Sciences (AIIMS) New Delhi 
Address  Room number 10A, Department of Cardiovascular Radiology and Endovascular Interventions, CN Centre, AIIMS, Ansari Nagar, New Delhi, 110029

South
DELHI
110029
India 
Phone  07051870260  
Fax    
Email  aks00712@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Priya Jagia 
Designation  Head and professor 
Affiliation  AIl India Institite of Medical Sciences (AIIMS), New Delhi 
Address  Department of cardiovascular radiology and endovascular interventions, CN centre, AIIMS, Ansari nagar, New Delhi

South
DELHI
110029
India 
Phone  09868114037  
Fax    
Email  drpjagia@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Priya Jagia 
Designation  Head and professor 
Affiliation  All India Institute of Medical Sciences (AIIMS) New Delhi 
Address  Department of cardiovascular radiology and endovascular interventions, CN Centre, AIIMS, New Delhi

South
DELHI
110049
India 
Phone  09868114037  
Fax    
Email  drpjagia@yahoo.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Self 
Address  Department of cardiovascular radiology and endovascular interventions 
Type of Sponsor  Other [Other] 
 
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 Priya Jagia  AIIMS New Delhi  Department of cardiovascular radiology and endovascular interventions
South
DELHI 
09868114037

drpjagia@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee All India Institute of Medical Sciences, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M70||Soft tissue disorders related to use, overuse and pressure, (2) ICD-10 Condition: M722||Plantar fascial fibromatosis, (3) ICD-10 Condition: Z48||Encounter for other postproceduralaftercare,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Non selective USG (Ultrasound) guided embolization technique in plantar fascitis.  Drug-Imipenem-cilastatin sodium, Dose- Single injection (500 mg reconsituted in 7 cc saline), Mode- Intra-arterial via posterior tibial artery, Non selectively using Ultrasound guided puncture 
Comparator Agent  Super-selective embolization technique in plantar fascitis  Drug-Imipenem-cilastatin sodium Dose- Single injection (500 mg reconsituted in 7 cc saline) Mode- Intra-arterial via super-selective cannulation of branches of posterior tibial artery supplying the plantar fascia. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  A patient with
1. Tenderness at the calcaneal attachment
2. Thickened plantar fascia (more than 4 mm) on preprocedural MRI.
3. No meaningful improvement with more than 3 months of conservative treatment (rest, anti-inflammatory
drugs, and physical therapy)
 
 
ExclusionCriteria 
Details  1. Uncorrectable coagulopathy as defined by INR more than 2.5 or platelet count less than 30,000
2. Iodine allergy resulting in anaphylaxis
3. Renal dysfunction as defined by eGFR of less than 30
4. Currently pregnant
5. Previous foot surgery
6. Not giving consent for the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Technical success, Post procedural pain relief   24 hours, 7 days, 1 month, 3 month, 6 month, 12 month 
 
Secondary Outcome  
Outcome  TimePoints 
Requirement of multiple reinterventions, Complications  24 hours, 7 days, 1 month, 3 month, 6 month, 12 month 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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)   15/12/2025 
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="3"
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  

Super-selective transcatheter arterial embolisation (TAE) is being established as a standard procedure in the pain management of musculoskeletal inflammatory conditions, particularly in patients who are refractory to conservative management. These conditions include knee osteoarthritis, frozen shoulder, and Achilles tendinopathy. The mechanism involves abnormal neo-vessel occlusion resulting from inflammation, leading to decreased inflammation.

However, evidence for TAE in plantar fascitis is limited to small observational studies and case reports. These studies describe two approaches: standard super-selective embolization and non-selective ultrasound-guided (USG) embolization, the latter involving the injection of a temporary embolic agent (imipenem/cilastatin) into the posterior tibial artery. Each method has distinct advantages and drawbacks. Super-selective embolization offers greater safety but is time-intensive and involves radiation exposure for both the patient and the operator. Conversely, non-selective USG-guided embolization requires fewer resources, such as microcatheters and digital subtraction angiography (DSA) equipment, but carries a minor theoretical risk of inadvertent embolization. The comparative efficacy of these techniques for pain relief in plantar fascitis remains inadequately explored due to a lack of robust comparative data.

This study is therefore designed to study the feasibility and compare the clinical outcomes of patients treated with super selective TAE versus Non-selective USG-guided embolization technique.

 
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