A prospective randomized study comparing polidocanol foam sclerotherapy with surgical treatment of patients with primary chronic venous insufficiency and ulcer

Ann Vasc Surg. 2015 Aug;29(6):1128-35. doi: 10.1016/j.avsg.2015.01.031. Epub 2015 May 21.

Abstract

Background: To compare polidocanol foam sclerotherapy with surgical treatment of patients with primary chronic venous insufficiency and active ulcer treated at a single vascular center.

Methods: Fifty-eight limbs of 56 patients with active ulcers were prospectively randomized to undergo either surgical treatment or foam sclerotherapy. Patients completed the Aberdeen Varicose Veins Questionnaire (AVVQ), the Venous Clinical Severity Score (VCSS), and Venous Disability Score (VDS). The follow-up was 502 ± 220 days.

Results: The ulcer healed in 100% and 91.3% of patients treated with surgery or foam sclerotherapy, respectively (P > 0.05). There were no significant differences in AVVQ, VCSS, and VDS between the 2 groups after the procedures (P = 0.45, 0.58, and 0.66, respectively; Mann-Whitney U test). Complications occurred in 14.2% and 13.0% in the surgical and foam sclerotherapy groups, respectively.

Conclusions: Surgical treatment and foam sclerotherapy achieved high rates of ulcer healing, without a statistically significant difference. Both treatments led to significant improvements in VCSS, VDS, AVVQ scores, demonstrating improvements in clinical outcomes and quality of life.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Brazil
  • Chronic Disease
  • Disability Evaluation
  • Female
  • Humans
  • Male
  • Middle Aged
  • Polidocanol
  • Polyethylene Glycols / administration & dosage*
  • Polyethylene Glycols / adverse effects
  • Prospective Studies
  • Quality of Life
  • Sclerosing Solutions / administration & dosage*
  • Sclerosing Solutions / adverse effects
  • Sclerotherapy / adverse effects
  • Sclerotherapy / methods*
  • Severity of Illness Index
  • Surveys and Questionnaires
  • Time Factors
  • Treatment Outcome
  • Varicose Ulcer / diagnosis
  • Varicose Ulcer / surgery
  • Varicose Ulcer / therapy*
  • Vascular Surgical Procedures* / adverse effects
  • Venous Insufficiency / diagnosis
  • Venous Insufficiency / surgery
  • Venous Insufficiency / therapy*
  • Wound Healing

Substances

  • Sclerosing Solutions
  • Polidocanol
  • Polyethylene Glycols