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Do Stem Cells or Platelet-Rich Fibrin Help Leg Ulcers Heal Better After Laser Treatment?

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.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/094590
Enrollment
36
Registered
2025-09-11
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I830- Varicose veins of lower extremities with ulcer

Interventions

Intervention1: 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 subcutaneousl

Sponsors

Hamza Ansari
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of 18 to 75 years age with chronic venous ulcer of lower limb of more than 6 weeks duration.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.Timepoint: 6 months after intervention

Secondary

MeasureTime frame
Number of days/weeks required for complete closure of the venous ulcer.Timepoint: Whenever the ulcer heals.;Incidence of ulcer recurrence within 6 months post-procedure.Timepoint: 6 months after intervention.;Any local or systemic side effects related to stem cell or Platelet Rich Fibrin therapy.Timepoint: 6 months after intervention

Countries

India

Contacts

Public ContactHamza Ansari

AIIMS, New Delhi

drasmalhi@gmail.com09968745855

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026