title: A Randomized Controlled Trial Comparing Telemedical and Standard Outpatient Monitoring of Diabetic Foot Ulcers.
abstract: OBJECTIVE
  The role of telemedical monitoring in diabetic foot ulcer care is still uncertain. Our aim was to compare telemedical and standard outpatient monitoring in the care of patients with diabetic foot ulcers in a randomized controlled trial.
  
  
  METHODS
  Of the 736 screened individuals with diabetic foot ulcers, 401 met the eligibility criteria and were randomized between October 2010 and November 2014. The per-protocol telemedical monitoring consisted of two consultations in the patient's own home and one consultation at the outpatient clinic. Standard practice consisted of three outpatient clinic visits. The three-visit cycle was repeated until study end point. The study end points were defined as complete ulcer healing, amputation, or death.
  
  
  RESULTS
  One hundred ninety-three individuals were randomized to telemedical monitoring and 181 to standard care. Demographics were similar in both groups. A cause-specific Cox proportional hazards model showed no difference in individuals monitored through telemedicine regarding wound healing (hazard ratio 1.11 [95% CI 0.87, 1.42], P = 0.42) or amputation (0.87 [0.54, 1.42], P = 0.59). We found a higher mortality incidence in the telemedical monitoring group compared with the standard outpatient monitoring group (8.68 [6.93, 10.88], P = 0.0001).
  
  
  CONCLUSIONS
  The findings of no significant difference regarding amputation and healing between telemedical and standard outpatient monitoring seem promising; however, for telemedical monitoring, a higher mortality throws into question the role of telemedicine in monitoring diabetic foot ulcers. Further studies are needed to investigate effects of telemedicine on mortality and other clinical outcomes and to identify patient subgroups that may have a poorer outcome through telemedical monitoring.
authors.affiliation: Department of Medical Endocrinology, Odense University Hospital, Odense, Denmark.
authors.forename: Benjamin S B
authors.identifier: http://orcid.org/0000-0002-7357-0755
authors.initials: BS
authors.lastname: Rasmussen
authors.affiliation: Department of Orthopaedic Surgery, Odense University Hospital, Odense, Denmark.
authors.forename: Johnny
authors.initials: J
authors.lastname: Froekjaer
authors.affiliation: Department of Medical Endocrinology, Odense University Hospital, Odense, Denmark.
authors.forename: Mads R
authors.identifier: http://orcid.org/0000-0002-1571-2612
authors.initials: MR
authors.lastname: Bjerregaard
authors.affiliation: Department of Orthopaedic Surgery, Odense University Hospital, Odense, Denmark.
authors.forename: Jens
authors.initials: J
authors.lastname: Lauritsen
authors.affiliation: Department of Internal Medicine, Odense University Hospital, Odense, Denmark.
authors.forename: Joergen
authors.initials: J
authors.lastname: Hangaard
authors.affiliation: Department of Orthopaedic Surgery, Kolding Hospital, Kolding, Denmark.
authors.forename: Claus W
authors.initials: CW
authors.lastname: Henriksen
authors.affiliation: Epidemiology, Biostatistics and Biodemography, University of Southern Denmark, Odense, Denmark.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Halekoh
authors.affiliation: Department of Medical Endocrinology, Odense University Hospital, Odense, Denmark knud.yderstraede@rsyd.dk.
authors.forename: Knud B
authors.initials: KB
authors.lastname: Yderstraede
mesh_terms: D000328:Adult; D000890:Anti-Infective Agents / Q000627:therapeutic use; D017719:Diabetic Foot / Q000188:drug therapy / Q000517:prevention & control / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018670:Monitoring, Ambulatory / Q000706:statistics & numerical data*; D010045:Outpatients / Q000706:statistics & numerical data*; D016016:Proportional Hazards Models; D012017:Referral and Consultation; D019114:Remote Consultation / Q000379:methods*; D012107:Research Design; D017216:Telemedicine / Q000379:methods*; D014945:Wound Healing
chemical_list: D000890:Anti-Infective Agents