title: Multicenter clinical trial on the performance and tolerability of the Hyaluronic acid-collagenase ointment for the treatment of chronic venous ulcers: a preliminary pilot study.
abstract: BACKGROUND
  Bed debridement is important to treat chronic wounds. Effective agents should remove the necrosis but protect the granulation tissue. We evaluated the performance and tolerability of a new composite ointment containing collagenase and hyaluronic acid for chronic venous ulcers.
  
  
  METHODS
  Subjects with class 6 venous ulcers (CEAP classification) of at least 6 months duration were prospectively recruited. The ointment was administered daily and follow-up visits were conducted on the fifth, 10th, 15th and 20th days. On each visit the necrotic area was measured with a grid. The moisture balance, odour, viability of non-necrotic areas and the presence of erythema were also assessed. Primary outcome was the percentage of subjects with complete debridement, secondary outcomes the time to complete healing, reduction of the lesion area, absence of necrotic tissue, presence of odor, erythema, hydration, any adverse events.
  
  
  RESULTS
  One hundred subjects were enrolled in four centres. All patients achieved complete debridement of the necrotic area and a significant reduction of the total ulcer area by day 20, while other parameters improved significantly over time. Only two patients experienced a transient leg oedema.
  
  
  CONCLUSIONS
  The combination of collagenase and hyaluronic acid is safe and effective for chronic venous ulcers.
authors.affiliation: Department of Surgery, Northampton General Hospital, Northampton, United Kingdom. ggravante@hotmail.com.
authors.forename: G
authors.initials: G
authors.lastname: Gravante
authors.forename: R
authors.initials: R
authors.lastname: Sorge
authors.forename: N
authors.initials: N
authors.lastname: Giordan
authors.forename: S R
authors.initials: SR
authors.lastname: Georgescu
authors.forename: S H
authors.initials: SH
authors.lastname: Morariu
authors.forename: I
authors.initials: I
authors.lastname: Stoicescu
authors.forename: V
authors.initials: V
authors.lastname: Clatici
mesh_terms: D000368:Aged; D002908:Chronic Disease; D017364:Collagenases / Q000008:administration & dosage*; D003646:Debridement; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009824:Ointments; D010865:Pilot Projects; D011446:Prospective Studies; D014647:Varicose Ulcer / Q000188:drug therapy*
chemical_list: D009824:Ointments; D006820:Hyaluronic Acid; D017364:Collagenases