OBJECTIVEThe 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 METHODSOf 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.
RESULTSOne hundred ninety-three individuals were randomized to telemedical monitoring and 181 to standard care. Demographics were similar in both groups. A causespecific 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).
CONCLUSIONSThe 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.Diabetes currently affects .387 million people worldwide, and this number is expected 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