Health Condition 1: I830- Varicose veins of lower extremities with ulcer
Conditions
Interventions
Sponsors
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
| Measure | Time 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
| Measure | Time 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
AIIMS, New Delhi