ArticleBMJ open2020
Does intensive glycaemic control promote healing in diabetic foot ulcers? - a feasibility study.
Article in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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Who cites it
10 citing papers in PubMed, 22 citations in OpenAlex.
- Impact of multidisciplinary nursing interventions and blood glucose control on diabetic foot ulcer healing, patient emotions, and satisfaction.World journal of psychiatry · 2025Article
- Unravelling the cardio-renal-metabolic-foot connection in people with diabetes-related foot ulceration: a narrative review.Cardiovascular diabetology · 2024Review
- Advancements in diabetic foot ulcer research: Focus on mesenchymal stem cells and their exosomes.Heliyon · 2024Review
- Effectiveness of stingless bee (Kelulut) honey versus conventional gel dressing in diabetic wound bed preparation: A randomized controlled trial.Journal of Taibah University Medical Sciences · 2024Article
- Detection, management, and prevention of diabetes-related foot disease in the Australian context.World journal of diabetes · 2023Review
- Effects of Intensive Glycemic Control on Serum Exosome miR-126-3p and miR-125b-1-3p Levels and Wound Healing in Patients with Diabetic Ulcers.Evidence-based complementary and alternative medicine : eCAM · 2023Article
- Diabetic foot ulcer: Challenges and future.World journal of diabetes · 2022Review
- Correction of hyperglycemia after surgery for diabetic foot infection and its association with clinical outcomes.BMC research notes · 2022Article
- Signaling pathways in cutaneous wound healing.Frontiers in physiology · 2022Review
- Bacteriological Profile and Antibiotic Susceptibility Pattern of Diabetic Foot Infection in a Tertiary Care Hospital in Lampung, Indonesia.The Malaysian journal of medical sciences : MJMS · 2021Article
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Authors and funding
7 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionOne 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.
objectivesTo 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.
designTwo substudies: one cross-sectional and one single-arm prospective.
settingSingle-centre secondary care diabetic foot clinic in New Zealand.
participantsSubstudy 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.
interventionSubstudy 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).
resultsProportion 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.
conclusionsAn adequately powered RCT requires cooperation between a large number of centres. Ulcer area logarithm should be primary endpoint. TRIAL REGISTRATION NUMBER: ANZCTR ACTRN12617001414303.
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