| CTRI Number |
CTRI/2026/01/100678 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
28/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Trans-arterial micro embolization of posterior tibial artery in refractory plantar fasciitis.] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Fixing Heel Pain: How a Simple, Low-Risk Treatment Can Help When Plantar Fasciitis Won’t Go Away |
|
Scientific Title of Study
|
Clinical Outcome of Transcatheter arterial microembolization in patients with refractory plantar fasciitis. |
| 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 Divyanshu Chauhan |
| Designation |
Post Graduate |
| Affiliation |
Vardhman Mahavir Medical College and Safdarajang Hospital |
| Address |
Department of Radiodiagnosis and IR, VMMC and Safdarjung Hospital, Ansari Nagar east, New Delhi- 110029
New Delhi DELHI 110029 India |
| Phone |
8178500445 |
| Fax |
|
| Email |
divyanshuchauhan6@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Geetika Sindhwani |
| Designation |
Associate Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarajang Hospital |
| Address |
Department of Radiodiagnosis and IR, VMMC and Safdarjung Hospital, Ansari Nagar east, New Delhi- 110029
New Delhi DELHI 110029 India |
| Phone |
8980808841 |
| Fax |
|
| Email |
sindhwani.geetika@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Divyanshu Chauhan |
| Designation |
Post Graduate |
| Affiliation |
Vardhman Mahavir Medical College and Safdarajang Hospital |
| Address |
Department of Radiodiagnosis and IR, VMMC and Safdarjung Hospital, Ansari Nagar east, New Delhi- 110029
New Delhi DELHI 110029 India |
| Phone |
8178500445 |
| Fax |
|
| Email |
divyanshuchauhan6@gmail.com |
|
|
Source of Monetary or Material Support
|
| VVardhman Mahavir Medical College and Safdarajang Hospital, New Delhi. |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarajang Hospital. |
| Address |
Vardhman Mahavir Medical College & Safdarjung Hospital Ansari Nagar Ring Road New Delhi 110029 |
| 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 |
| Dr Divyanshu Chauhan |
VMMC and Safdarjung Hospital |
Room no.47 (DSA Room), New Emergency Building, Department of Radiodiagnosis, Vardhman Mahavir Medical College & Safdarjung Hospital, Ansari Nagar, Ring Road, New Delhi 110029 South West DELHI |
8178500445
divyanshuchauhan6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, VMMC and Safdarjung Hospital |
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 |
NIL |
NIL |
| Intervention |
Trans-artereial Microembolization. |
Trans-arterial micro-embolization of the arteries (posterior tibial artery) showing showing abnormal vascular blush post-digital subtraction angiography |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All participants with age more than 18 years with a clinical
diagnosis of chronic plantar fasciitis with no improvement or persistent symptoms on
conservative treatment.
|
|
| ExclusionCriteria |
| Details |
Patients with severe vascular disease, active infection, or significant allergies to embolic
agents.
Patients who have recently received treatments that could interfere with TAME, such as
steroid injections, might be excluded unless a sufficient waiting period has passed.
Patients with severe comorbidities or poor overall health are excluded.
Known coagulopathy or recent trauma or surgery involving the affected limb.
Pregnancy & other contraindications to radiation exposure.
Inflammatory & Connective Tissue Activity |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in VAS score after the procedure and on follow up visits |
Follow up assessment at 1 and 4 months post procedure. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Plantar fascia thickness change in ultrasound pre-procedure and on follow up. |
Follow up USG at 1 and 4 months post procedure. |
|
|
Target Sample Size
|
Total Sample Size="35" Sample Size from India="35"
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)
|
27/01/2026 |
| 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="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Plantar fasciitis is the most common cause of heel pain, traditionally considered an inflammatory condition. However, it is now better understood as a consequence of biomechanical stress and degenerative changes within the plantar fascia. The plantar fascia is a thick fibrous band that runs beneath the longitudinal arch, extending from the medial calcaneal tubercle to the plantar plates of the proximal phalanges. Patients typically experience intense heel pain during their first steps in the morning, which tends to subside with daily activity. This condition affects both sedentary and physically active individuals, with a higher prevalence in females. While plantar fasciitis usually affects one foot, approximately 30% of patients report bilateral symptoms.
Standard Treatment: Initial treatment is primarily conservative and includes rest and NSAIDs to reduce discomfort, Orthoses such as heel pads, stretching exercises targeting the gastrocnemius and plantar fascia. If refractory to conservative treatment, then minimal invasive procedures can be done which includes injections including corticosteroids and botulinum toxin and adjunct therapies such as shockwave therapy, therapeutic ultrasound, and platelet-rich plasma (PRP) infusion. Although most cases resolve within 6 months of standard therapy, a subset of patients continues to suffer from chronic pain and may be considered for surgical intervention. However, surgery is not always successful and can carry a risk of complications, including nerve injury, infection, and prolonged recovery.
Emerging Treatment: Transcatheter Arterial Micro- Embolization (TAME) Chronic plantar fasciitis has been linked to increased vascularity in the affected fascial tissue. This increased blood flow may contribute to persistent pain through ongoing nociceptor stimulation and the release of inflammatory mediators. Transcatheter arterial micro-embolization (TAME) is a minimally invasive procedure that selectively occludes the abnormal neo-vessels supplying the plantar fascia. By cutting off this aberrant blood flow, the therapy aims to reduce inflammation and pain. Recent studies have shown that TAME is effective in treating chronic musculoskeletal conditions such as osteoarthritis, tendinopathy, and enthesopathy—including plantar fasciitis. |