Dumont IJ, Lepeut MS, Tsirtsikolou DM, Popielarz SM, Cordonnier MM, Fayard AJ, Devemy F, Fernandez E, Basuyaux O, Jeffcoate WJ, et al.
Diabetic medicine : a journal of the British Diabetic Association. Date of publication 2009 Aug 1;volume 26(8):778-82.
1. Diabet Med. 2009 Aug;26(8):778-82. doi: 10.1111/j.1464-5491.2009.02772.x.
A proof-of-concept study of the effectiveness of a removable device for
offloading in patients with neuropathic ulceration of the foot: the Ransart boot.
Dumont IJ(1), Lepeut MS, Tsirtsikolou DM, Popielarz SM, Cordonnier MM, Fayard AJ,
Devemy F, Fernandez E, Basuyaux O, Jeffcoate WJ.
Author information:
(1)Centre du Pied, Ransart, Belgium. isa.dumont@skynet.be
AIM: To undertake a proof-of-concept study to determine whether a removable
offloading device (the Ransart boot) for the management of diabetic foot ulcers
(DFU) was as effective as reports of non-removable devices.
RESEARCH DESIGN AND METHODS: This observational study used the Ransart boot for
patients with DFU, in seven specialist centres. If a patient had two or more
ulcers, one was selected as the index ulcer. Ulcers were classified by the
University of Texas (UT) system.
RESULTS: There were 135 patients (mean age 60.3 +/- 11.4 years); 96 (71.1%) male.
Median ulcer duration at presentation was 90 [interquartile range (IQR) 30-1825]
days. Seven were lost to follow-up, seven developed other major illnesses and
four died; outcomes were documented in the remaining 117. Eighty-two (70.1% of
117) healed, after a median (IQR) 60 (43-99) days, while 22 (18.8%) ulcers were
resolved by amputation (one major). The remaining 13 (11.1%) patients were judged
non-compliant. There was a close correlation between ulcer classification at
baseline and both time to healing (P < 0.001 chi(2)-test) and amputation (P <
0.001; Spearman's rank correlation coefficient). There was a positive correlation
between ulcer duration at presentation and time to healing (P < 0.02), UT class
(P < 0.01), glycated haemoglobin (P < 0.02) and amputation (P < 0.04).
CONCLUSIONS: Time to healing and incidence of amputation were comparable with
those previously reported for non-removable devices. Given that a removable
device is much more acceptable to the patient, the effectiveness, cost and
acceptability of the removable devices, such as the Ransart boot, need to be
compared with a non-removable device in a randomized trial. Diabet. Med. 26,
778-782 (2009).
DOI: 10.1111/j.1464-5491.2009.02772.x
PMID: 19709147 [Indexed for MEDLINE]
