Rasmussen BS, Froekjaer J, Bjerregaard MR, Lauritsen J, Hangaard J, Henriksen CW, Halekoh U, Yderstraede KB, et al.
Diabetes care. Date of publication 2015 Sep 1;volume 38(9):1723-9.
1. Diabetes Care. 2015 Sep;38(9):1723-9. doi: 10.2337/dc15-0332. Epub 2015 Jun 26.
A Randomized Controlled Trial Comparing Telemedical and Standard Outpatient
Monitoring of Diabetic Foot Ulcers.
Rasmussen BS(1), Froekjaer J(2), Bjerregaard MR(1), Lauritsen J(2), Hangaard
J(3), Henriksen CW(4), Halekoh U(5), Yderstraede KB(6).
Author information:
(1)Department of Medical Endocrinology, Odense University Hospital, Odense,
Denmark.
(2)Department of Orthopaedic Surgery, Odense University Hospital, Odense,
Denmark.
(3)Department of Internal Medicine, Odense University Hospital, Odense, Denmark.
(4)Department of Orthopaedic Surgery, Kolding Hospital, Kolding, Denmark.
(5)Epidemiology, Biostatistics and Biodemography, University of Southern Denmark,
Odense, Denmark.
(6)Department of Medical Endocrinology, Odense University Hospital, Odense,
Denmark knud.yderstraede@rsyd.dk.
Comment in
Diabetes Care. 2016 Jan;39(1):e11.
Diabetes Care. 2016 Jan;39(1):e9-10.
MMW Fortschr Med. 2016 Jun 9;158(11):40.
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 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.
© 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.
DOI: 10.2337/dc15-0332
PMID: 26116717 [Indexed for MEDLINE]
