Insulin treatment for diabetic foot ulcers

Substudy 1 - Entry criteria and treatment acceptability. Study design: Cross-sectional study (no follow-up). Target Feasibility Issues: 1 and 2 Accrual period: 24 weeks Participants: All patients 18 years of age or over with diabetes and a current foot ulcer presenting at the CMH Multidisciplinary Diabetes Foot Clinic during the study period will be invited to participate. Main entry criteria: Incident ulcer, as determined from patient history and inspection at the clinic. Outcomes: Fulfillment of each full study entry criterion (dichotomous); DiabMedSat (diabetes medications satisfaction questionnaire) sub scores. Assessments: For each participant consenting by signing a patient information sheet to substudy 1, a delegated member of the research team will record demographic data and study entry criteria status and patients will be invited to complete a diabetes patient satisfaction questionnaire (DiabMedSat). Their foot wound will be inspected which is a routine procedure of every patient attending the clinic. Demographic and other clinical data would already be available on electronic patient data base and patient clinical records. Substudy 2 Study design: Single-arm prospective study; Target feasibility issues: 2 to 6 Accrual period duration: 16 weeks; Intervention and follow-up period duration: 24 weeks Participants: Twenty adult patients with diabetes and foot ulcer attending the CMH Multidisciplinary Diabetes Foot Clinic. Main entry criteria: All patients who have participated in Substudy 1 and meet study inclusion/exclusion criteria will be offered to participate in the Substudy 2 until the target sample size is reached. The patient information sheet for Substudy 2 will be discussed and patients given the option of taking it home to consider. They will be subsequently contacted and if willing to participate will attend visit 1 of this substudy. At this visit the informed consent of patients will be obtained by a member of the study team after further clarifying their questions as needed. Study procedures are illustrated in the schedule attached .We intend to recruit 20 patients spread over 16 weeks from commencement of the trial. Patients recruited for substudy 2 would be assessed by the podiatrist (vascular status by toe pressure measurements, digital photographic planimetry of the ulcer/ulcers and microcirculation by laser speckled imaging technique) and then receive relevant usual treatment including ulcer debridement, organisation of proper orthotics, treatment of infection if needed etc. Except for digital photographic imaging, laser speckled imaging and completing questionnaires, the treatment consists in routine care. Visits 1-4 will be weekly, visits 5-6 fortnightly and visits 7-9 monthly. If additional visits are required for extra debridement they will be arranged as required. Dose Adjustments : Either the diabetes nurse specialist or the medical doctor or both will comprehensively assess the patient’s glycaemic status on the basis of the patients monitoring records and either instigate insulin therapy or upgrade treatment of existing insulin therapy. Intervention: Our proposed intervention is an 11-week intensive insulin therapy programme. Insulin will be administered in addition to oral hypoglycaemic tablet therapy consistent with International Guidelines (International Diabetes Federation; Global guideline for type 2 diabetes). Either intermediate acting insulin or long acting insulin will be started (in patients who are not on insulin) or adjusted (in patients who are already on insulin) and short acting meal time insulin will be added in relevant cases to improve glycaemic profile. All participants will be expected to perform routine home blood glucose monitoring and maintain regular telephone contact with the principal investigator and/or the diabetes nurse specialist for dose adjustment and stabilisation advice using a treat-to-target approach for insulin dose adjustment. Participants will be contacted by telephone at least twice weekly for dose adjustment advice .The treatment targets are capillary blood glucose (CBG) levels of 4-7 mmol/L before meals and <10 mmol/L after meals, no more than 2 episodes of mild hypoglycaemia per week, and HbA1c either equal to or less than <53 mmol/mol (<7.0%). Adherance to treatment regime will be assessed by reviewing blood glucose monitoring records.