title: Topical formulation of heparin is effective in reducing the symptoms of superficial venous thrombosis: a monocenter, observer-blind, placebo-controlled randomized study.
abstract: OBJECTIVE
  The aim of the present, randomized, placebo controlled study was to assess the dose-dependent symptom reduction efficacy, safety and tolerability of heparin-spraygel (Viatromb 2.400 IU/g heparin spraygel) in patients with superficial vein thrombosis (SVT) of the lower limbs.
  
  
  METHODS
  A number of clinically relevant objectives; time to onset and intensity of symptoms' reduction reflected also by rescue medication consumption were considered and assessed.
  
  
  RESULTS
  Pain reduction between the two time-points (days 0 and 7) was significant within both treatment groups (active drug and placebo). However, subjects treated with active drug reported a mean pain reduction (VAS) of 76.21 mm (93.13% decrease); in subjects treated with placebo it was 50.36 (61.35%) mm (P<0.0001). The difference in pain reduction between the active drug and placebo groups was significant (P<0.05). The proportion of responders (subjects with at least 50%reduction in pain (VAS) on day 7 and day 14) was higher within subjects treated with Viatromb (P<0.05). The extension of erythema, evaluated by planimetry indicated a significantly higher reduction (day 0 to 7 and 0 to 14) in Viatromb-treated subjects in comparison with placebo. In the Viatromb group, the reduction in thrombus size was remarkable towards placebo (P<0.05). Reduction of edema and pain (VRS) had comparable time courses. Both investigator's and subject's global assessment of efficacy were significantly better with Viatromb. No adverse events or reactions were reported during the study and the follow up period.
  
  
  CONCLUSIONS
  Viatromb was significantly more effective than placebo in the symptomatic treatment of SVT.
authors: Irvine3 Labs, Department of Biomedical Sciences, Chieti - Pescara University, Pescara, Italy. cardres@abol.it.
authors: G
authors: G
authors: Belcaro
authors: M R
authors: MR
authors: Cesarone
authors: M
authors: M
authors: Dugall
authors: B
authors: B
authors: Feragalli
authors: E
authors: E
authors: Ippolito
authors: M
authors: M
authors: Corsi
authors: M
authors: M
authors: Hosoi
authors: U
authors: U
authors: Cornelli
authors: A
authors: A
authors: Ledda
authors: G
authors: G
authors: Gizzi
authors: R
authors: R
authors: Luzzi
authors: M
authors: M
authors: Georgiev
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000368:Aged; D004305:Dose-Response Relationship, Drug; D004487:Edema / Q000188:drug therapy / Q000473:pathology; D005260:Female; D006493:Heparin / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy / Q000503:physiopathology; D010147:Pain Measurement; D010349:Patient Compliance; D016037:Single-Blind Method; D016896:Treatment Outcome; D020246:Venous Thrombosis / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology
chemical_list: D006493:Heparin