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...
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BMJ Publishing Group
2020-01-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/1/e029009.full |
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| author | Ajith Dissanayake Alain C Vandal Veronica Boyle Diane Park Bobbie Milne Roger Grech Anthony Ng |
| author_facet | Ajith Dissanayake Alain C Vandal Veronica Boyle Diane Park Bobbie Milne Roger Grech Anthony Ng |
| author_sort | Ajith Dissanayake |
| collection | DOAJ |
| description | 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 |
| format | Article |
| id | doaj-art-9b7470884d8d414f97eb58c4c87948bd |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-01-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-9b7470884d8d414f97eb58c4c87948bd2024-12-06T22:05:09ZengBMJ Publishing GroupBMJ Open2044-60552020-01-0110110.1136/bmjopen-2019-029009Does intensive glycaemic control promote healing in diabetic foot ulcers? – a feasibility studyAjith Dissanayake0Alain C Vandal1Veronica Boyle2Diane Park3Bobbie Milne4Roger Grech5Anthony Ng61 Endocrinology and Diabetes, Counties Manukau District Health Board, Auckland, New Zealand2 Department of Statistics, University of Auckland, Auckland, New ZealandVirginia G. Piper Center for Personalized Diagnostics, Biodesign Institute, Arizona State University, Tempe, Arizona, USA4 Faculty of Health and Environmental Sciences, Auckland University of Technology, Auckland, New Zealand5 Middlemore Clinical Trials, Auckland, New Zealand6 Podiatry, Counties Manukau Health, Auckland, New Zealand6 Podiatry, Counties Manukau Health, Auckland, New ZealandIntroduction 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 ACTRN12617001414303https://bmjopen.bmj.com/content/10/1/e029009.full |
| spellingShingle | Ajith Dissanayake Alain C Vandal Veronica Boyle Diane Park Bobbie Milne Roger Grech Anthony Ng Does intensive glycaemic control promote healing in diabetic foot ulcers? – a feasibility study BMJ Open |
| title | Does intensive glycaemic control promote healing in diabetic foot ulcers? – a feasibility study |
| title_full | Does intensive glycaemic control promote healing in diabetic foot ulcers? – a feasibility study |
| title_fullStr | Does intensive glycaemic control promote healing in diabetic foot ulcers? – a feasibility study |
| title_full_unstemmed | Does intensive glycaemic control promote healing in diabetic foot ulcers? – a feasibility study |
| title_short | Does intensive glycaemic control promote healing in diabetic foot ulcers? – a feasibility study |
| title_sort | does intensive glycaemic control promote healing in diabetic foot ulcers a feasibility study |
| url | https://bmjopen.bmj.com/content/10/1/e029009.full |
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