Health Condition 1: I832- Varicose veins of lower extremities with both ulcer and inflammation
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Dr Kiran Makineni
Eligibility
Inclusion criteria
Inclusion criteria: -Adults aged 21 to 80 years at the time of procedure. -Documented reflux (less than 0.5 seconds) GSV, ASV or SSV. -Vein diameter up to 12 mm, with a minimum 1 cm skin depth. -Presence of one or more symptoms attributable to venous incompetence, including visible dilated veins, pain, swelling, heaviness, pruritus, night cramps, skin changes, or ulceration. -CEAP classification C2 to C6. -Patient has chosen VenaSeal• nonthermal, nontumescent endovenous ablation after understanding the risks and benefits of available modalities -Willingness to attend follow-up visits and comply with post- procedure compression.
Exclusion criteria
Exclusion criteria: -Prior treatment of the target GSV, ASV, or SSV. -Symptomatic peripheral arterial disease with ankle-brachial index (ABI) less than 0.8. -History of deep vein thrombosis, pulmonary embolism, or venous aneurysm more than 12 mm. -Tortuous target vein not amenable to catheter placement. -Known hypersensitivity to cyanoacrylate adhesives or adhesives (skin glue, acrylic nails, eyelash glue, adhesive bandages). -Significant autoimmune or systemic inflammatory disorders. -History of multiple drug or food allergies. -Active psoriasis or atopic dermatitis. -Diameter of target vein more than 12 mm in any segment. -Patients unwilling/unable to provide informed consent or adhere to follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duplex confirmed complete closure of the treated target vein at 1 and 3 months, defined as absence of flow with no patent segment more than 5 cm on color flow, compression, and pulsed Doppler ultrasound.Timepoint: Baseline, 1 month and 3 month follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| -Incidence & characterization of adverse events, including phlebitis, hypersensitivity, & recanalization. -Requirement for re-intervention or adjunctive procedures during follow-up. -Time to closure and/or recanalization. -Change in Venous Clinical Severity Score (VCSS) at 1 & 3 months. -Patient-reported quality of life (QoL) at 3 & 6 months (telephonically), using SF- 36. Timepoint: Baseline, 1, 3 & 6 months follow up | — |
Countries
India
Contacts
Public ContactDr V S Bedi
Sir Ganga Ram Hospital
Outcome results
None listed