title: A prospective randomized study comparing polidocanol foam sclerotherapy with surgical treatment of patients with primary chronic venous insufficiency and ulcer.
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.
authors.affiliation: Vascular and Endovascular Surgery Department, Clinics Hospital of São Paulo University Medical School, São Paulo, Brazil.
authors.forename: Walter
authors.initials: W
authors.lastname: Campos
authors.affiliation: Vascular and Endovascular Surgery Department, Clinics Hospital of São Paulo University Medical School, São Paulo, Brazil. Electronic address: inezohashi@gmail.com.
authors.forename: Inez Ohashi
authors.initials: IO
authors.lastname: Torres
authors.affiliation: Vascular and Endovascular Surgery Department, Clinics Hospital of São Paulo University Medical School, São Paulo, Brazil.
authors.forename: Erasmo Simão
authors.initials: ES
authors.lastname: da Silva
authors.affiliation: Vascular and Endovascular Surgery Department, Clinics Hospital of São Paulo University Medical School, São Paulo, Brazil.
authors.forename: Ivan Benaduce
authors.initials: IB
authors.lastname: Casella
authors.affiliation: Vascular and Endovascular Surgery Department, Clinics Hospital of São Paulo University Medical School, São Paulo, Brazil.
authors.forename: Pedro
authors.initials: P
authors.lastname: Puech-Leão
mesh_terms: D000328:Adult; D001938:Brazil; D002908:Chronic Disease; D004185:Disability Evaluation; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077423:Polidocanol; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D011788:Quality of Life; D012597:Sclerosing Solutions / Q000008:administration & dosage* / Q000009:adverse effects; D015911:Sclerotherapy / Q000009:adverse effects / Q000379:methods*; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D014647:Varicose Ulcer / Q000175:diagnosis / Q000601:surgery / Q000628:therapy*; D014656:Vascular Surgical Procedures / Q000009:adverse effects; D014689:Venous Insufficiency / Q000175:diagnosis / Q000601:surgery / Q000628:therapy*; D014945:Wound Healing
chemical_list: D012597:Sclerosing Solutions; D000077423:Polidocanol; D011092:Polyethylene Glycols