Does intensive glycaemic control promote healing in diabetic foot ulcers? - a feasibility study.

INTRODUCTION: One in four diabetes patients will develop a foot ulcer over their lifetime. The role of glycaemic control in the healing of foot ulcers in diabetes patients is not supported by randomised controlled trial (RCT) data. OBJECTIVES: To determine the feasibility of an RCT of glycaemic control with intensive insulin therapy in diabetic foot ulcer, by assessing: entry criteria, fasting capillary blood glucose (FCBG) medication satisfaction and sensitivity of different ulcer-healing endpoints to glycaemic control. DESIGN: Two substudies: one cross-sectional and one single-arm prospective. SETTING: Single-centre secondary care diabetic foot clinic in New Zealand. PARTICIPANTS: Substudy 1: 78 participants consisting of all people ≥18 years with a diabetic foot ulcer presenting to the clinic over 35 weeks in 2015.Substudy 2: 15 participants from Substudy 1 consenting to intensive insulin therapy. INTERVENTION: Substudy 1: None.Substudy 2: Intensive insulin therapy with standard podiatry care over 24 weeks. OUTCOME: Substudy 1: Proportion of participants satisfying potential RCT entry criteria; medication satisfaction (Diabetes Medication Satisfaction).Substudy 2: FCBG, index ulcer healing time, index ulcer size, health-related quality of life (HRQoL; EuroQol 5 Dimensions 5 Levels and Diabetic Foot Ulcer Scale-Short Form). RESULTS: Proportion in Substudy 1 satisfying all entry criteria was 31% (95% CI 21 to 42). FCBG values decreased between baseline and study end (difference -3.7 mmol/L, 95% CI -6.5 to -0.8); 83% (95% CI 44 to 95) of ulcers healed by 24 weeks. FCBG correlated negatively with medication satisfaction. Ulcer area logarithm was most sensitive to FCBG changes, displaying significant negative correlation with HRQoL outcomes. Detecting a 30% between-group difference in this outcome (80% power, α=5%) requires 220 participants per arm, achievable within 1 year with 15 centres similar to study setting. CONCLUSIONS: An adequately powered RCT requires cooperation between a large number of centres. Ulcer area logarithm should be primary endpoint. TRIAL REGISTRATION NUMBER: ANZCTR ACTRN12617001414303.

Pedobarography as a clinical tool in the management of diabetic feet in New Zealand: a feasibility study.

BACKGROUND: The peripheral complications of diabetes mellitus remain a significant risk to lower-limb morbidity. In New Zealand, risk of diabetes, comorbidity and lower-limb amputation are highly-differential between demographic groups, particularly ethnicity. There is growing and convincing evidence that the use of pedobarography - or plantar pressure measurement - can usefully inform diabetic foot care, particularly with respect to the prevention of re-ulceration among high-risk patients. METHODS: For the current feasibility study, we embedded pedobarographic measurements into three unique diabetic foot clinic settings in the New Zealand context, and collected pedobarographic data from n = 38 patients with diabetes using a platform-based (Novel Emed) and/or in-shoe-based system (Novel Pedar). Our aim was to assess the feasibility of incorporating pedobarographic testing into the clinical care of diabetic feet in New Zealand. RESULTS AND CONCLUSIONS: We observed a high response rate and positive self-reported experience from participants. As part of our engagement with participants, we observed a high degree of lower-limb morbidity, including current ulceration and chronic foot deformities. The median time for pedobarographic testing (including study introduction and consenting) was 25 min. Despite working with a high-risk population, there were no adverse events in this study. In terms of application of pedobarography as a clinical tool in the New Zealand context, the current feasibility study leads us to believe that there are two avenues that deserve further investigation: a) the use of pedobarography to inform the design and effectiveness of offloading devices among high-risk diabetic patients; and b) the use of pedobarography as a means to increase offloading footwear and/or orthoses compliance among high-risk diabetic patients. Both of these objectives deserve further examination in New Zealand via clinical trial.