A proof-of-concept study of the effectiveness of a removable device for offloading in XXXX with neuropathic ulceration of the foot: the Ransart boot.

@entity1 @entity1066 @entity4760
AIM: To undertake a proof-of-concept study to determine whether a removable offloading device (the Ransart boot) for the management of @entity4760 ( @entity4760 ) was as effective as reports of non-removable devices. RESEARCH DESIGN AND METHODS: This observational study used the Ransart boot for @entity1 with @entity4760 , in seven specialist centres. If a @entity1 had two or more @entity1066 , one was selected as the index @entity1066 . Ulcers were classified by the University of Texas (UT) system. RESULTS: There were 135 @entity1 (mean age 60.3 +/- 11.4 years); 96 (71.1%) male. Median @entity1066 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%) @entity1066 were resolved by amputation (one major). The remaining 13 (11.1%) @entity1 were judged non-compliant. There was a close correlation between @entity1066 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 @entity1066 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 @entity1 , 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).
