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

Show simple item record Dissanayake, Ajith Vandal, Alain C Boyle, Veronica Park, Diane Milne, Bobbie Grech, Roger Ng, Anthony
dc.coverage.spatial England 2022-07-12T03:22:42Z 2022-07-12T03:22:42Z 2020-01-20
dc.identifier.citation (2020). BMJ Open, 10(1), e029009-.
dc.identifier.issn 2044-6055
dc.description.abstract <h4>Introduction</h4>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.<h4>Objectives</h4>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.<h4>Design</h4>Two substudies: one cross-sectional and one single-arm prospective.<h4>Setting</h4>Single-centre secondary care diabetic foot clinic in New Zealand.<h4>Participants</h4>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.<h4>Intervention</h4>Substudy 1: None.Substudy 2: Intensive insulin therapy with standard podiatry care over 24 weeks.<h4>Outcome</h4>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).<h4>Results</h4>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.<h4>Conclusions</h4>An adequately powered RCT requires cooperation between a large number of centres. Ulcer area logarithm should be primary endpoint.<h4>Trial registration number</h4>ANZCTR ACTRN12617001414303.
dc.format.medium Electronic
dc.language eng
dc.publisher BMJ
dc.relation.ispartofseries BMJ open
dc.rights Items in ResearchSpace are protected by copyright, with all rights reserved, unless otherwise indicated. Previously published items are made available in accordance with the copyright policy of the publisher.
dc.subject Humans
dc.subject Diabetic Foot
dc.subject Insulin
dc.subject Blood Glucose
dc.subject Hypoglycemic Agents
dc.subject Endpoint Determination
dc.subject Cross-Sectional Studies
dc.subject Feasibility Studies
dc.subject Podiatry
dc.subject Wound Healing
dc.subject Quality of Life
dc.subject Adult
dc.subject Aged
dc.subject Aged, 80 and over
dc.subject Middle Aged
dc.subject Patient Satisfaction
dc.subject New Zealand
dc.subject Female
dc.subject Male
dc.subject Glycated Hemoglobin A
dc.subject Glycemic Control
dc.subject statistics & research methods
dc.subject wound management
dc.subject Clinical Research
dc.subject Diabetes
dc.subject Clinical Trials and Supportive Activities
dc.subject Skin
dc.subject Metabolic and endocrine
dc.subject Science & Technology
dc.subject Life Sciences & Biomedicine
dc.subject Medicine, General & Internal
dc.subject General & Internal Medicine
dc.subject VALIDATION
dc.subject MANAGEMENT
dc.subject RISK
dc.subject 1103 Clinical Sciences
dc.subject Clinical
dc.subject Clinical Medicine and Science
dc.subject Nutrition
dc.subject 1117 Public Health and Health Services
dc.subject 1199 Other Medical and Health Sciences
dc.title Does intensive glycaemic control promote healing in diabetic foot ulcers? - a feasibility study.
dc.type Journal Article
dc.identifier.doi 10.1136/bmjopen-2019-029009
pubs.issue 1
pubs.begin-page e029009
pubs.volume 10 2022-06-07T01:39:51Z
dc.rights.holder Copyright: The author en
dc.identifier.pmid 31964660 (pubmed)
pubs.publication-status Published
dc.rights.accessrights en
pubs.subtype Research Support, Non-U.S. Gov't
pubs.subtype research-article
pubs.subtype Journal Article
pubs.elements-id 793300 Science Statistics
dc.identifier.eissn 2044-6055
dc.identifier.pii bmjopen-2019-029009
pubs.number ARTN e029009
pubs.record-created-at-source-date 2022-06-07 2020-01

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