I Idris1, F Game, W Jeffcoate. 1. Foot Ulcer Trials Unit, Department of Diabetes and Endocrinology, City Hospital, Nottingham, UK. iidris@aol.com
Abstract
AIM: To undertake a pilot study to determine the feasibility of a definitive trial of the effect of close glycaemic control on healing of foot ulcers in diabetes. METHODS:All patients attending a dedicated multidisciplinary clinic for the management of established ulcers over a 20-week period were systematically screened for inclusion in a randomised, single-blinded study. FINDINGS:Two hundred individuals with foot ulcers attended the clinic during the recruitment period, but only nine met the predefined inclusion and exclusion criteria. One of these was withdrawn because of an adverse event immediately before recruitment, two proved incapable of administering insulin injections and were withdrawn prior to randomization. Four withheld consent, and one was advised to withhold consent by his community nurse. One was randomised and completed the 3-month study. The study was abandoned at 20 weeks when it was decided that it would be unlikely that a sufficient number of suitable patients would ever be recruited, and that it would therefore be unethical to approach further subjects. CONCLUSIONS: It was concluded that although evidence is required to guide future practice in this field, the study design chosen was not feasible.
RCT Entities:
AIM: To undertake a pilot study to determine the feasibility of a definitive trial of the effect of close glycaemic control on healing of foot ulcers in diabetes. METHODS: All patients attending a dedicated multidisciplinary clinic for the management of established ulcers over a 20-week period were systematically screened for inclusion in a randomised, single-blinded study. FINDINGS: Two hundred individuals with foot ulcers attended the clinic during the recruitment period, but only nine met the predefined inclusion and exclusion criteria. One of these was withdrawn because of an adverse event immediately before recruitment, two proved incapable of administering insulin injections and were withdrawn prior to randomization. Four withheld consent, and one was advised to withhold consent by his community nurse. One was randomised and completed the 3-month study. The study was abandoned at 20 weeks when it was decided that it would be unlikely that a sufficient number of suitable patients would ever be recruited, and that it would therefore be unethical to approach further subjects. CONCLUSIONS: It was concluded that although evidence is required to guide future practice in this field, the study design chosen was not feasible.
Authors: Ajith Dissanayake; Alain C Vandal; Veronica Boyle; Diane Park; Bobbie Milne; Roger Grech; Anthony Ng Journal: BMJ Open Date: 2020-01-20 Impact factor: 2.692