A Randomized Controlled Trial Comparing Telemedical and Standard Outpatient Monitoring of Diabetic Foot Ulcers Diabetes Care 2015;38:1723–1729 | DOI: 10.2337/dc15-0332 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. RESEARCH DESIGN AND 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 out- patient 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 monitor- ing 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 tele- medical 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 sub- groups that may have a poorer outcome through telemedical monitoring. Diabetes currently affects .387 million people worldwide, and this number is ex- pected to rise to .592 million individuals worldwide by 2035 (1). In Denmark, 320,545 people suffer from diabetes, and it is estimated that a further 200,000 individuals are undiagnosed; a further 750,000 have impaired glucose tolerance (2). Approximately 7–15% of the population with diabetes will have one or several foot ulcers during a lifetime, and up to 70% of these ulcers will recur during a 5-year period (3). Diabetic foot ulcers lead to ;500 major amputations every year in 1 Department of Medical Endocrinology, Odense University Hospital, Odense, Denmark 2 Department of Orthopaedic Surgery, Odense University Hospital, Odense, Denmark 3 Epidemiology, Biostatistics and Biodemogra- phy, University of Southern Denmark, Odense, Denmark 4 Department of Internal Medicine, Odense Uni- versity Hospital, Odense, Denmark 5 Department of Orthopaedic Surgery, Kolding Hospital, Kolding, Denmark Corresponding author: Knud B. Yderstraede, knud.yderstraede@rsyd.dk. Received 15 February 2015 and accepted 6 June 2015. Clinical trial reg. no. NCT01608425, clinicaltrials .gov. This article contains Supplementary Data online at http://care.diabetesjournals.org/lookup/ suppl/doi:10.2337/dc15-0332/-/DC1. © 2015 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. Benjamin S.B. Rasmussen, 1 Johnny Froekjaer, 2 Mads R. Bjerregaard, 1 Jens Lauritsen, 2 Joergen Hangaard, 4 Claus W. Henriksen, 5 Ulrich Halekoh, 3 and Knud B. Yderstraede 1 Diabetes Care Volume 38, September 2015 1723 EMERGING TECHNOLOGIES AND THERAPEUTICS Downloaded from http://diabetesjournals.org/care/article-pdf/38/9/1723/624865/dc150332.pdf by guest on 14 May 2022