title: Therapeutic effectiveness of a Calendula officinalis extract in venous leg ulcer healing.
abstract: OBJECTIVE
  Non-healing venous leg ulcers (VLUs) have a significant effect on patients' quality of life and substantially increase expenditures in health-care systems. The aim of this study was to evaluate the clinical efficacy of the Calendula officinalis extract, Plenusdermax, in the treatment of VLUs.
  
  
  METHODS
  Patients treated with Calendula officinalis extract (n=38) and control patients (n=19) were evaluated every two weeks for 30 weeks or until their ulcers healed. Assessments included determination of the wound area by planimetry, infection control, and evaluation of the clinical aspects of the wounds. The percentage of healing velocity per week (%HVw), taking the initial area at baseline into account, was also determined.
  
  
  RESULTS
  The proportion of the treatment patients achieving complete epithelialisation was 72 % and 32 % in the treatment and control groups, respectively. The average healing time was approximately 12 weeks in the treatment group and 25 % in control patients. Patients with ulcers treated with Calendula officinalis extract had a significant 4-fold increase in percentage healing velocity per week, 7.4 %, compared with 1.7 % in the control group. No adverse events were observed during the Calendula officinalis extract treatment.
  
  
  CONCLUSIONS
  Our findings indicate that Calendula officinalis extract is an effective treatment for VLUs.
  
  
  BACKGROUND
  The authors have no conflict of interest.
authors.affiliation: Proamplus Clinical Research Advisory LTD, Pinhais, Paraná, Brazil.
authors.forename: M
authors.initials: M
authors.lastname: Buzzi
authors.affiliation: Phytoplenus Bioativos S.A., Pinhais, Paraná, Brazil.
authors.forename: F
authors.initials: F
authors.lastname: de Freitas
authors.affiliation: Hospital da Santa Casa de Misericórdia de Curitiba, Departamento of Dermatologia, Curitiba, Paraná, Brazil.
authors.forename: M
authors.initials: M
authors.lastname: de Barros Winter
mesh_terms: D000368:Aged; D020838:Calendula; D016022:Case-Control Studies; D005260:Female; D006801:Humans; D007871:Leg Ulcer / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D010936:Plant Extracts / Q000627:therapeutic use*; D011446:Prospective Studies; D016896:Treatment Outcome; D014647:Varicose Ulcer / Q000188:drug therapy*; D014945:Wound Healing / Q000187:drug effects
chemical_list: D010936:Plant Extracts
keywords: bioactive fraction of Calendula officinalis; chronic ulcers; venous leg ulcer; wound healing