title: Clinical trials in peripheral vascular disease: pipeline and trial designs: an evaluation of the ClinicalTrials.gov database.
abstract: BACKGROUND
  Tremendous advances have occurred in therapies for peripheral vascular disease (PVD); until recently, however, it has not been possible to examine the entire clinical trial portfolio of studies for the treatment of PVD (both arterial and venous disease).
  
  
  RESULTS
  We examined interventional trials registered in ClinicalTrials.gov from October 2007 through September 2010 (n=40,970) and identified 676 (1.7%) PVD trials (n=493 arterial only, n=170 venous only, n=13 both arterial and venous). Most arterial studies investigated lower-extremity peripheral artery disease and acute stroke (35% and 24%, respectively), whereas most venous studies examined deep vein thrombosis/pulmonary embolus prevention (42%) or venous ulceration (25%). A placebo-controlled trial design was used in 27% of the PVD trials, and 4% of the PVD trials excluded patients >65 years of age. Enrollment in at least 1 US site decreased from 51% of trials in 2007 to 41% in 2010. Compared with noncardiology disciplines, PVD trials were more likely to be double-blinded, to investigate the use of devices and procedures, and to have industry sponsorship and assumed funding source, and they were less likely to investigate drug and behavioral therapies. Geographic access to PVD clinical trials within the United States is limited to primarily large metropolitan areas.
  
  
  CONCLUSIONS
  PVD studies represent a small group of trials registered in ClinicalTrials.gov, despite the high prevalence of vascular disease in the general population. This low number, compounded by the decreasing number of PVD trials in the United States, is concerning and may limit the ability to inform current clinical practice of patients with PVD.
authors.affiliation: From the Duke Clinical Research Institute, Duke University, Durham, NC (S.S., M.R.P., K.C., B.A.T.-M., W.S.J., A.T., R.M.C.); North Carolina State University, Raleigh (B.A.T.-M.); University of California, San Francisco, San Francisco (M.S.C.); Ochsner Heart & Vascular Institute, New Orleans, LA (C.J.W.); Brigham and Women's Hospital and Harvard Medical School, Boston, MA (D.L.B.); University of California, Davis, Sacramento (J.R.L.); and University of Colorado School of Medicine and CPC Clinical Research, Aurora (W.R.H.).
authors.forename: Sumeet
authors.initials: S
authors.lastname: Subherwal
authors.affiliation: From the Duke Clinical Research Institute, Duke University, Durham, NC (S.S., M.R.P., K.C., B.A.T.-M., W.S.J., A.T., R.M.C.); North Carolina State University, Raleigh (B.A.T.-M.); University of California, San Francisco, San Francisco (M.S.C.); Ochsner Heart & Vascular Institute, New Orleans, LA (C.J.W.); Brigham and Women's Hospital and Harvard Medical School, Boston, MA (D.L.B.); University of California, Davis, Sacramento (J.R.L.); and University of Colorado School of Medicine and CPC Clinical Research, Aurora (W.R.H.). manesh.patel@duke.edu.
authors.forename: Manesh R
authors.initials: MR
authors.lastname: Patel
authors.affiliation: From the Duke Clinical Research Institute, Duke University, Durham, NC (S.S., M.R.P., K.C., B.A.T.-M., W.S.J., A.T., R.M.C.); North Carolina State University, Raleigh (B.A.T.-M.); University of California, San Francisco, San Francisco (M.S.C.); Ochsner Heart & Vascular Institute, New Orleans, LA (C.J.W.); Brigham and Women's Hospital and Harvard Medical School, Boston, MA (D.L.B.); University of California, Davis, Sacramento (J.R.L.); and University of Colorado School of Medicine and CPC Clinical Research, Aurora (W.R.H.).
authors.forename: Karen
authors.initials: K
authors.lastname: Chiswell
authors.affiliation: From the Duke Clinical Research Institute, Duke University, Durham, NC (S.S., M.R.P., K.C., B.A.T.-M., W.S.J., A.T., R.M.C.); North Carolina State University, Raleigh (B.A.T.-M.); University of California, San Francisco, San Francisco (M.S.C.); Ochsner Heart & Vascular Institute, New Orleans, LA (C.J.W.); Brigham and Women's Hospital and Harvard Medical School, Boston, MA (D.L.B.); University of California, Davis, Sacramento (J.R.L.); and University of Colorado School of Medicine and CPC Clinical Research, Aurora (W.R.H.).
authors.forename: Beth A
authors.initials: BA
authors.lastname: Tidemann-Miller
authors.affiliation: From the Duke Clinical Research Institute, Duke University, Durham, NC (S.S., M.R.P., K.C., B.A.T.-M., W.S.J., A.T., R.M.C.); North Carolina State University, Raleigh (B.A.T.-M.); University of California, San Francisco, San Francisco (M.S.C.); Ochsner Heart & Vascular Institute, New Orleans, LA (C.J.W.); Brigham and Women's Hospital and Harvard Medical School, Boston, MA (D.L.B.); University of California, Davis, Sacramento (J.R.L.); and University of Colorado School of Medicine and CPC Clinical Research, Aurora (W.R.H.).
authors.forename: W Schuyler
authors.initials: WS
authors.lastname: Jones
authors.affiliation: From the Duke Clinical Research Institute, Duke University, Durham, NC (S.S., M.R.P., K.C., B.A.T.-M., W.S.J., A.T., R.M.C.); North Carolina State University, Raleigh (B.A.T.-M.); University of California, San Francisco, San Francisco (M.S.C.); Ochsner Heart & Vascular Institute, New Orleans, LA (C.J.W.); Brigham and Women's Hospital and Harvard Medical School, Boston, MA (D.L.B.); University of California, Davis, Sacramento (J.R.L.); and University of Colorado School of Medicine and CPC Clinical Research, Aurora (W.R.H.).
authors.forename: Michael S
authors.initials: MS
authors.lastname: Conte
authors.affiliation: From the Duke Clinical Research Institute, Duke University, Durham, NC (S.S., M.R.P., K.C., B.A.T.-M., W.S.J., A.T., R.M.C.); North Carolina State University, Raleigh (B.A.T.-M.); University of California, San Francisco, San Francisco (M.S.C.); Ochsner Heart & Vascular Institute, New Orleans, LA (C.J.W.); Brigham and Women's Hospital and Harvard Medical School, Boston, MA (D.L.B.); University of California, Davis, Sacramento (J.R.L.); and University of Colorado School of Medicine and CPC Clinical Research, Aurora (W.R.H.).
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: White
authors.affiliation: From the Duke Clinical Research Institute, Duke University, Durham, NC (S.S., M.R.P., K.C., B.A.T.-M., W.S.J., A.T., R.M.C.); North Carolina State University, Raleigh (B.A.T.-M.); University of California, San Francisco, San Francisco (M.S.C.); Ochsner Heart & Vascular Institute, New Orleans, LA (C.J.W.); Brigham and Women's Hospital and Harvard Medical School, Boston, MA (D.L.B.); University of California, Davis, Sacramento (J.R.L.); and University of Colorado School of Medicine and CPC Clinical Research, Aurora (W.R.H.).
authors.forename: Deepak L
authors.initials: DL
authors.lastname: Bhatt
authors.affiliation: From the Duke Clinical Research Institute, Duke University, Durham, NC (S.S., M.R.P., K.C., B.A.T.-M., W.S.J., A.T., R.M.C.); North Carolina State University, Raleigh (B.A.T.-M.); University of California, San Francisco, San Francisco (M.S.C.); Ochsner Heart & Vascular Institute, New Orleans, LA (C.J.W.); Brigham and Women's Hospital and Harvard Medical School, Boston, MA (D.L.B.); University of California, Davis, Sacramento (J.R.L.); and University of Colorado School of Medicine and CPC Clinical Research, Aurora (W.R.H.).
authors.forename: John R
authors.initials: JR
authors.lastname: Laird
authors.affiliation: From the Duke Clinical Research Institute, Duke University, Durham, NC (S.S., M.R.P., K.C., B.A.T.-M., W.S.J., A.T., R.M.C.); North Carolina State University, Raleigh (B.A.T.-M.); University of California, San Francisco, San Francisco (M.S.C.); Ochsner Heart & Vascular Institute, New Orleans, LA (C.J.W.); Brigham and Women's Hospital and Harvard Medical School, Boston, MA (D.L.B.); University of California, Davis, Sacramento (J.R.L.); and University of Colorado School of Medicine and CPC Clinical Research, Aurora (W.R.H.).
authors.forename: William R
authors.initials: WR
authors.lastname: Hiatt
authors.affiliation: From the Duke Clinical Research Institute, Duke University, Durham, NC (S.S., M.R.P., K.C., B.A.T.-M., W.S.J., A.T., R.M.C.); North Carolina State University, Raleigh (B.A.T.-M.); University of California, San Francisco, San Francisco (M.S.C.); Ochsner Heart & Vascular Institute, New Orleans, LA (C.J.W.); Brigham and Women's Hospital and Harvard Medical School, Boston, MA (D.L.B.); University of California, Davis, Sacramento (J.R.L.); and University of Colorado School of Medicine and CPC Clinical Research, Aurora (W.R.H.).
authors.forename: Asba
authors.initials: A
authors.lastname: Tasneem
authors.affiliation: From the Duke Clinical Research Institute, Duke University, Durham, NC (S.S., M.R.P., K.C., B.A.T.-M., W.S.J., A.T., R.M.C.); North Carolina State University, Raleigh (B.A.T.-M.); University of California, San Francisco, San Francisco (M.S.C.); Ochsner Heart & Vascular Institute, New Orleans, LA (C.J.W.); Brigham and Women's Hospital and Harvard Medical School, Boston, MA (D.L.B.); University of California, Davis, Sacramento (J.R.L.); and University of Colorado School of Medicine and CPC Clinical Research, Aurora (W.R.H.).
authors.forename: Robert M
authors.initials: RM
authors.lastname: Califf
mesh_terms: D000671:Amputation, Surgical / Q000706:statistics & numerical data; D002986:Clinical Trials as Topic / Q000379:methods* / Q000706:statistics & numerical data / Q000639:trends; D016208:Databases, Factual; D018795:Device Approval; D004311:Double-Blind Method; D062305:Geographic Mapping; D006297:Health Services Accessibility; D006801:Humans; D020407:Internet; D018579:Patient Selection; D058729:Peripheral Arterial Disease / Q000628:therapy; D016491:Peripheral Vascular Diseases / Q000517:prevention & control / Q000628:therapy*; D010919:Placebos; D012107:Research Design; D012109:Research Support as Topic; D020521:Stroke / Q000628:therapy; D014481:United States; D014689:Venous Insufficiency / Q000601:surgery / Q000628:therapy
chemical_list: D010919:Placebos
keywords: clinical trials as topic; peripheral vascular diseases; prevention and control; registries