title: Difficult-to-heal wounds of mixed arterial/venous and venous etiology: a cost-effectiveness analysis of extracellular matrix.
abstract: OBJECTIVE
  Difficult-to-heal wounds pose clinical and economic challenges, and cost-effective treatment options are needed.
  
  
  OBJECTIVE
  The aim of this study is to determine the cost-effectiveness of extracellular matrix (ECM) relative to standard of care (SC) on wound closure for the treatment of mixed arterial/venous (A/V) or venous leg ulcers (VLUs).
  
  
  METHODS
  A two-stage Markov model was used to predict the expected costs and outcomes of wound closure for ECM and SC. Outcome data used in the analysis were taken from an 8-week randomized clinical trial that directly compared ECM and SC. Patients were followed up for an additional 6 months to assess wound closure. Forty-eight patients completed the study; 25 for ECM and 23 for SC. SC was defined as a standard moist wound dressing. Transition probabilities for the Markov states were estimated from the clinical trial.
  
  
  METHODS
  The economic outcome of interest was direct cost per closed-wound week. Resource utilization was based on the treatment regimen used in the clinical trial. Costs were derived from standard cost references. The payer's perspective was taken.
  
  
  RESULTS
  ECM-treated wounds closed, on average, after 5.4 weeks of treatment, compared with 8.3 weeks for SC wounds (P=0.02). Furthermore, complete wound closure was significantly higher in patients treated with ECM (P<0.05), with 20 wounds closed in the ECM group (80%) and 15 wounds closed in the SC group (65%). After 8 months, patients treated with ECM had substantially higher closed-wound weeks compared with SC (26.0 weeks versus 22.0 weeks, respectively). Expected direct costs per patient were $2,527 for ECM and $2,540 for SC (a cost savings of $13).
  
  
  CONCLUSIONS
  ECM yielded better clinical outcomes at a slightly lower cost in patients with mixed A/V and VLUs. ECM is an effective treatment for wound healing and should be considered for use in the management of mixed A/V and VLUs.
authors.affiliation: Department of Dermatology, University of Pisa, Pisa, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Romanelli
authors.affiliation: Department of Life Sciences, Truven Health Analytics, Fort Worth, TX, USA; Department of Pharmacotherapy, University of North Texas Health Sciences Center, Fort Worth, TX, USA.
authors.forename: Adrienne M
authors.initials: AM
authors.lastname: Gilligan
authors.affiliation: Department of Pharmacotherapy, University of North Texas Health Sciences Center, Fort Worth, TX, USA; Department of Market Access, Smith and Nephew Inc., Fort Worth, TX, USA.
authors.forename: Curtis R
authors.initials: CR
authors.lastname: Waycaster
authors.affiliation: Department of Dermatology, University of Pisa, Pisa, Italy.
authors.forename: Valentina
authors.initials: V
authors.lastname: Dini
keywords: adjunct therapy; compression therapy; economic outcomes; extracellular matrix; venous leg ulcers; wound care