Prospective exploration of the effect of adiposity and associated microbial factors on healing and progression of diabetic foot ulcers in Tanzania: study protocol of a longitudinal cohort study
| Autor: | Agbor Ako, Faraja Chiwanga, Mabulla Mchembe, Lindsay Kendall, Agricola Joachim, Fredirick Mashili, Zulfiqar Abbas, Said Aboud, Juliet Addo |
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| Rok vydání: | 2019 |
| Předmět: |
Adult
Male medicine.medical_specialty 030209 endocrinology & metabolism diabetic foot ulcers 030204 cardiovascular system & hematology Tanzania Amputation Surgical 03 medical and health sciences 0302 clinical medicine Informed consent Recurrence Clinical endpoint Protocol Outpatient clinic Medicine Humans Cumulative incidence Longitudinal Studies Obesity Prospective Studies Prospective cohort study Wound Healing adiposity business.industry microbial factors General Medicine medicine.disease Diabetic foot Diabetic Foot Diabetes and Endocrinology Family medicine Case-Control Studies Good clinical practice Disease Progression Female business Declaration of Helsinki |
| Zdroj: | BMJ Open |
| ISSN: | 2044-6055 |
| Popis: | BackgroundDiabetic foot ulcers (DFUs) are associated with high morbidity and mortality in low-income countries. This coexists with an increasing prevalence of obesity which has been reported to alter antimicrobial susceptibility and potentially affect the outcome of infected foot ulcers. This study aims to determine whether adiposity and local microbial factors affect the progression and healing of foot ulcers in people with type 2 diabetes in hospital settings in Tanzania.Methods and analysisA prospective cohort of 300 individuals with type 2 diabetes presenting with DFUs at an outpatient clinic will be enrolled into the study. At baseline, participants will be stratified into normal and high adiposity groups (150 per group) as measured by bioelectrical impedance analysis (BIA). Both groups will receive DFU management according to locally appropriate standards of care and will be followed up for 24 weeks or until complete wound healing, whichever occurs first. The primary end point is complete wound healing at 24 weeks while secondary end points are ulcer progression (worsening or improving), amputation and death. Enrolling 150 participants per group will have a minimum power of 80% to detect a 20% difference in cumulative incidence of complete ulcer healing (at the 5% level of statistical significance) between the normal and high adiposity groups.Ethical considerations and dissemination of resultsThis study will be conducted in compliance with the independent institutional review boards (IRBs), informed consent guidelines, the declaration of Helsinki and International Conference on Harmonisation, Good Clinical Practice Guidelines. Ethical clearance has been granted by the Muhimbili University of Health and Allied Sciences ethical review board (MUHAS Ref. No. DA.282/298/01 .C/). Permissions to conduct the study have been granted by the Abbas Medical Centre and the Muhimbili Academic Medical Centre (MAMC).Progress and results emanating from this work will be communicated to the scientific community through conference presentations, short communications (using journal letters and interesting case reports) and peer-reviewed publications. When necessary, through proper channels, popular means of communication (newspapers, magazines and online communications) will be used to inform policy and the public.Trial registration numberNCT03960255; Pre-results. |
| Databáze: | OpenAIRE |
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