| 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
|
|
|
Primary Sponsor
|
| Name |
Hamza Ansari |
| Address |
AIIMS, New Delhi, Ansari Nagar 110029 |
| Type of Sponsor |
Other [Self] |
|
|
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 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
|
|
|
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. |