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

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.OutcomeSubstudy 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 numberANZCTR ACTRN12617001414303

Intensive Glycemic Control for Diabetic Foot Ulcer Healing: A Multicentric, Randomized, Parallel Arm, Single-Blind, Controlled Study Protocol (INGLOBE Study)

“…21 Recently, a feasibility cross-sectional study with a single-arm prospective evaluation (substudy) of intensive insulin therapy for DFU opined that cooperation between large number of centers would be required for adequate power of the study. 22 To the best of our knowledge, there are no randomized controlled study to substantiate an improved wound healing with intensive glycemic management.…”

Correction of hyperglycemia after surgery for diabetic foot infection and its association with clinical outcomes

“…Two other articles suggested a possible benefit of intensified insulin treatment in DFU healing. Both stated that future randomized studies are under way in field of non-infected DFUs [ 13 , 14 ]. The most recently published International Workling Ground on the Diabetic Foot guideline on infection suggests clinicians should “ Optimize glycaemic control, if necessary with insulin ,” but without going into further details [ 15 ].…”

Bacteriological Profile and Antibiotic Susceptibility Pattern of Diabetic Foot Infection in a Tertiary Care Hospital in Lampung, Indonesia

“…Poor glycaemic control, measured as HbA1c, fasting blood glucose or even single random blood glucose, has been shown to predict ulceration and subsequent amputation. In addition, it has also been reported to inhibit wound healing, making treatment even more difficult ( 14 – 15 ). In the present study, the mean of random blood glucose was 265 (123.2) mg/dL, above the acceptable limit for good glycaemic control.…”