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CTRI Number  CTRI/2025/09/094590 [Registered on: 11/09/2025] Trial Registered Prospectively
Last Modified On: 10/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological
Stem Cell Therapy
Medical Device 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Do Stem Cells or Platelet-Rich Fibrin Help Leg Ulcers Heal Better After Laser Treatment? 
Scientific Title of Study   Role of addition of Stem Cells or Platelet Rich Fibrin in the healing of chronic lower extremity venous ulcers compared to Endo Venous Laser Ablation alone.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Hamza Ansari 
Designation  Junior Resident 
Affiliation  AIIMS, New Delhi 
Address  Room no. 80, Department of Radiodiagnosis and Interventional radiology, AIIMS, New Delhi, Ansari Nagar

South
DELHI
110029
India 
Phone  8920068306  
Fax    
Email  hamzaansari18027@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Amarinder Singh Malhi 
Designation  Assistant professor 
Affiliation  AIIMS, New Delhi 
Address  Room no. 80, Department of Radiodiagnosis and Interventional radiology, AIIMS, New Delhi, Ansari Nagar

South
DELHI
110029
India 
Phone  09968745855  
Fax    
Email  drasmalhi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Hamza Ansari 
Designation  Junior Resident 
Affiliation  AIIMS, New Delhi 
Address  Room no. 80, Department of Radiodiagnosis and Interventional radiology, AIIMS, New Delhi, Ansari Nagar

South
DELHI
110029
India 
Phone  8920068306  
Fax    
Email  hamzaansari18027@gmail.com  
 
Source of Monetary or Material Support  
AIIMS, New Delhi 
 
Primary Sponsor  
Name  Hamza Ansari 
Address  AIIMS, New Delhi, Ansari Nagar 110029 
Type of Sponsor  Other [Self] 
 
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 Hamza Ansari  AIIMS, New Delhi  Room no.80, Department of Radiodiagnosis and interventional radiology, AIIMS, New Delhi, Ansari Nagar
South
DELHI 
8920068306

hamzaansari18027@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institution Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I830||Varicose veins of lower extremities with ulcer,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Endo Venous Laser Ablation  Patients of chronic venous ulcer of lower limb will be treated with Endo Venous Laser Ablation alone on a single day. 
Intervention  Endo Venous Laser Ablation with Platelet rich fibrin application  Patients of venous ulcer will be treated with Endo Venous Laser Ablation with Platelet rich fibrin topical application once weekly for a maximum of 6 weeks or till ulcer heals whichever occurs earlier. 
Intervention  Endo Venous Laser Ablation with Stem Cell injection  Patients of venous ulcer will be treated with Endo Venous Laser Ablation with 5ml Stem Cell injection intradermally or subcutaneously on a single day  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients of 18 to 75 years age with chronic venous ulcer of lower limb of more than 6 weeks duration. 
 
ExclusionCriteria 
Details  1. Patients with ulcers of non-venous origin.
2. Patients with active local or systemic infection.
3. Immunocompromised patients.
4. Patients with uncontrolled diabetes mellitus.
5. Patients with severe anemia.
6. Pregnant and lactating women.
7. Patients with history of malignancy or undergoing chemotherapy or radiotherapy.
8. Patients with poor general condition or unfit for procedure as per clinical judgement.
9. Severe hypercoagulability syndromes or having DVT.
10. Patient not willing to give consent.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Percentage reduction in ulcer size over a specific time period after additional treatment with stem cells or Platelet Rich Fibrin as compared to EVLA alone.  6 months after intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Number of days/weeks required for complete closure of the venous ulcer.  Whenever the ulcer heals. 
Incidence of ulcer recurrence within 6 months post-procedure.  6 months after intervention. 
Any local or systemic side effects related to stem cell or Platelet Rich Fibrin therapy.  6 months after intervention 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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)   30/10/2025 
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="2"
Months="0"
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  

Chronic venous ulcers are a significant health burden, often leading to prolonged morbidity and reduced quality of life. Conventional treatment strategies, including compression therapy and surgical interventions, have limitations in healing time and recurrence rates. Endovenous Laser Ablation (EVLA) is an effective modality for treating underlying venous insufficiency; however, it does not directly promote ulcer healing. Recent advances in regenerative medicine have introduced autologous stem cells and platelet-rich derivatives such as PRF as promising adjuncts to enhance tissue repair.

This randomized, prospective, interventional study aims to evaluate and compare the effectiveness of three treatment modalities:
1. EVLA alone (control group)
2. EVLA with perilesional injection of autologous stem cells (mesenchymal stem cells derived from bone marrow)
3. EVLA with perilesional injection of autologous platelet-rich fibrin (PRF)

Patients diagnosed with chronic venous ulcers due to superficial venous insufficiency will be randomly assigned into one of the three treatment groups. The primary outcome measure will be the rate of ulcer healing, assessed by reduction in ulcer size and complete healing over a 6-month period. Secondary outcomes will include recurrence rate at 6 months and any adverse events related to the procedures.

This study is expected to provide evidence regarding the utility of biologic adjuncts like stem cells and PRF in accelerating healing and improving outcomes in venous ulcer patients, potentially shaping future management protocols for chronic wounds.


 
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