A Randomized Controlled Trial Comparing Telemedical and Standard Outpatient Monitoring of Diabetic Foot Ulcers

Abstract

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

Response to Comment on Rasmussen et al. A Randomized Controlled Trial Comparing Telemedical and Standard Outpatient Monitoring of Diabetic Foot Ulcers. Diabetes Care 2015;38:1723–1729

“…We appreciate the comments made by Muller et al (1) to our recent article in Diabetes Care (2). Their findings corroborate those of ours, including the logistics for dissemination of technology, the lack of ownership among the number of stakeholders in a complex setup, the need for patient stratification to define particular subgroups that might or might not benefit from telemedical monitoring, and other aspects.…”

Telenephrology: Providing Healthcare to Remotely Located Patients with Chronic Kidney Disease

“…Remote delivery of healthcare has been promoted and studied as a viable method to deliver high-quality medical care in several medical specialties [8][9][10][11][12][13][14]. However, few studies have evaluated the role of telemedicine in nephrology.…”

Conditions for success in introducing telemedicine in diabetes foot care: a qualitative inquiry

“…Telehealth technology, often labeled as telemedicine [1], can be helpful in meeting these follow up care needs [2]. Telemedicine supports distant interaction between health care professionals in primary and specialized care, thereby reducing the need for patients to visit the hospital [3], and the uptake of this kind of technology to deliver health care services at a distance is expanding [4].…”