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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]
Appears in following Topics:
Diabetic Foot Ulcer - Treatment
Offloading Devices