Early and Intensive Glycemic Control for Diabetic Foot Ulcer Healing: A Prospective Observational Nested Cohort Study

We aimed to assess the effect of glycemic control on diabetic foot ulcer (DFU) healing. A prospective nested cohort study was employed of individuals with poorly controlled diabetes (glycated hemoglobin [HbA1c] >9%) and neuropathic DFU of >2-week duration. All individuals received standard diabetes and ulcer interventions for 12 weeks. Baseline demographic characteristics, ulcer area (automated assessment by wound zoom camera), and biochemical parameters were analyzed. The cohort was stratified into ulcer healed and unhealed groups. Ulcer area and glycemic parameters at 4 and 12 weeks on follow up were compared. Forty-three individuals (47 DFU) with baseline HbA1c 11.6% and ulcer area 9.87 cm2 were enrolled. After 12 weeks, mean HbA1c was 7.2%, 17 ulcers closed (healed group) and 30 ulcers did not close (unhealed group). The median time to ulcer healing was 10 weeks. Individuals in the healed group had lower fasting blood glucose ( P = .010), postprandial blood glucose ( P = .006), and HbA1c at 4 weeks ( P = .001), and 12 weeks (0.018) compared to the unhealed group. Cox-regression analysis that revealed lower baseline ulcer area ( P = .013) and HbA1c at 4 weeks ( P = .009) significantly predicted DFU healing by 12 weeks. Baseline ulcer area of >10.58 cm2 and HbA1c at 4 weeks of >8.15% predicted delayed DFU healing. In conclusion, early and intensive glycemic control in the first 4 weeks of treatment initiation is associated with greater healing of DFU independent of initial ulcer area.

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

The International Journal of Lower Extremity Wounds ◽

10.1177/1534734620952245 ◽

2020 ◽

pp. 153473462095224

Author(s):

Ashu Rastogi ◽

Satinath Mukhopadhyay ◽

Jay Prakash Sahoo ◽

Arun Mennon ◽

Amritava Ghosh ◽

...

Keyword(s):

Blood Glucose ◽

Glycemic Control ◽

Diabetic Foot ◽

Glucose Control ◽

Foot Ulcer ◽

Diabetic Foot Ulcer ◽

Controlled Study ◽

Insulin Regimen ◽

Intensive Glycemic Control ◽

Glycemic Targets

Hyperglycemia impairs healing of diabetic foot ulcer (DFU). But there is no evidence regarding benefit of intensive glucose control for healing of DFU. We plan to conduct a randomized, parallel arm, controlled study to assess the role of intensive glycemic management in comparison to conventional glucose control for healing of DFU. Participants with neuropathic DFU (infected or uninfected) having hemoglobin A1c (HbA1c) >8% and without evidence of osteomyelitis from 7 tertiary care hospitals will be enrolled. They will undergo a 2-week run-in phase for optimization of comorbidities, ulcer debridement, and counseling regarding self-monitoring of blood glucose (SMBG). Subsequently, they will be randomized to “intensive glycemic control” arm defined by glycemic targets of fasting blood glucose (FBG) <130 mg/dL, postprandial BG <180 mg/dL, and HbA1c <8%, with basal-bolus insulin regimen and frequent titration of insulin to achieve glycemic targets. The “conventional” arm will continue on prior treatment (oral antidiabetic drugs) with no titration unless meeting rescue criteria. Ulcer area will be calculated by automated wound assessment device (WoundlyClinial app) weekly for first 4 weeks, and less frequently until the 24th week. Standard treatment for DFU, off-loading, and counseling for foot care will be provided in both arms. The primary outcome measure will be number of wounds closed at 12th and 24th weeks. A multivariate regression analysis will be performed to identify the predictors of wound healing with baseline HbA1c, diabetes duration, wound size, wound duration, and background therapies as independent variable. This study will provide the much needed guidance to set optimum glucose targets in people with DFU.

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Clinical Profile of Patients with Diabetic Foot Ulcer Treated Conservatively or Surgically and Effect of Risk Factors on Ulcer Healing

International Journal of Research and Review ◽

10.52403/ijrr.20210629 ◽

2021 ◽

Vol 8 (6) ◽

pp. 238-244

Author(s):

Ved Prakash

Keyword(s):

Risk Factors ◽

Peripheral Neuropathy ◽

Glycemic Control ◽

Ulcer Healing ◽

Diabetic Foot ◽

Foot Ulcer ◽

Diabetic Foot Ulcer ◽

Clinical Profile ◽

Diabetic Patients ◽

Duration Of Diabetes

Objective: The aim of this study was to assess the clinical profile of patients with diabetic foot ulcer treated conservatively or surgically and effect of risk factors on ulcer healing. Methods: This was a retrospective observational study conducted in tertiary medical teaching hospital where medical records of diabetic patients who were admitted with foot problem were evaluated. All diabetic patients who were aged >18 years and admitted with DFU were included in this study. A structured proforma was used to collect data from the medical record. SPSS version 20.0 was used to perform the statistical analysis. Result: 280 subjects with diabetic foot ulcer (DFU) were evaluated in this study. 71% ulcers were healed where as 11% were persisted unhealed. Patients who were undergone for amputation 12% were minor (Foot only) and 4% were major (above the ankle). A statistically significant association between age, duration of diabetes, glycemic control peripheral neuropathy, and ulcer size were found with diabetic foot ulcer healing. Conclusion: Modifiable factors like good glycemic control, early management of ulcers and early treatment of peripheral neuropathy can influence Diabetic foot ulcer outcomes. Special care should be provided to diabetic subjects who are aged and have longer duration of diabetes. Keywords: Diabetic foot ulcers, ulcer severity, clinical profile, Wagner’s Classification, outcome.

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

BMJ Open ◽

10.1136/bmjopen-2019-029009 ◽

2020 ◽

Vol 10 (1) ◽

pp. e029009 ◽

Cited By ~ 1

Author(s):

Ajith Dissanayake ◽

Alain C Vandal ◽

Veronica Boyle ◽

Diane Park ◽

Bobbie Milne ◽

...

Keyword(s):

Glycaemic Control ◽

Insulin Therapy ◽

Intensive Insulin Therapy ◽

Ulcer Healing ◽

Diabetic Foot ◽

Foot Ulcer ◽

Diabetic Foot Ulcer ◽

Foot Ulcers ◽

Ulcer Area ◽

Diabetes Patients

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

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Diabetic foot ulcer, the effect of resource‐poor environments on healing time and direct cost: A cohort study during Syrian crisis

International Wound Journal ◽

10.1111/iwj.13651 ◽

2021 ◽

Author(s):

Mhd Belal Alsabek ◽

Abdul Razzak Abdul Aziz

Keyword(s):

Cohort Study ◽

Direct Cost ◽

Diabetic Foot ◽

Foot Ulcer ◽

Diabetic Foot Ulcer ◽

Healing Time ◽

Syrian Crisis ◽

Resource Poor

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Intermittent cycles of remote ischemic preconditioning augment diabetic foot ulcer healing

Wound Repair and Regeneration ◽

10.1111/wrr.12269 ◽

2015 ◽

Vol 23 (2) ◽

pp. 191-196 ◽

Cited By ~ 14

Author(s):

Gad Shaked ◽

David Czeiger ◽

Anwar Abu Arar ◽

Tiberiu Katz ◽

Ilana Harman-Boehm ◽

...

Keyword(s):

Ischemic Preconditioning ◽

Ulcer Healing ◽

Diabetic Foot ◽

Foot Ulcer ◽

Diabetic Foot Ulcer ◽

Remote Ischemic Preconditioning

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Health literacy and diabetic foot ulcer healing

Wound Repair and Regeneration ◽

10.1111/wrr.12311 ◽

2015 ◽

Vol 23 (3) ◽

pp. 299-301 ◽

Cited By ~ 16

Author(s):

David J. Margolis ◽

Michelle Hampton ◽

Ole Hoffstad ◽

D. Scot Malay ◽

Stephen Thom

Keyword(s):

Health Literacy ◽

Ulcer Healing ◽

Diabetic Foot ◽

Foot Ulcer ◽

Diabetic Foot Ulcer

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Severity and duration of diabetic foot ulcer (DFU) before seeking care as predictors of healing time: A retrospective cohort study

PLoS ONE ◽

10.1371/journal.pone.0177176 ◽

2017 ◽

Vol 12 (5) ◽

pp. e0177176 ◽

Cited By ~ 30

Author(s):

Hilde Smith-Strøm ◽

Marjolein M. Iversen ◽

Jannicke Igland ◽

Truls Østbye ◽

Marit Graue ◽

...

Keyword(s):

Cohort Study ◽

Retrospective Cohort Study ◽

Diabetic Foot ◽

Retrospective Cohort ◽

Foot Ulcer ◽

Diabetic Foot Ulcer ◽

Healing Time

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Risk factors associated with adverse outcomes in a population-based prospective cohort study of people with their first diabetic foot ulcer

Journal of Diabetes and its Complications ◽

10.1016/j.jdiacomp.2007.09.004 ◽

2007 ◽

Vol 21 (6) ◽

pp. 341-349 ◽

Cited By ~ 84

Author(s):

Kirsty Winkley ◽

Daniel Stahl ◽

Trudie Chalder ◽

Michael E. Edmonds ◽

Khalida Ismail

Keyword(s):

Risk Factors ◽

Cohort Study ◽

Prospective Cohort Study ◽

Diabetic Foot ◽

Prospective Cohort ◽

Foot Ulcer ◽

Diabetic Foot Ulcer ◽

Population Based ◽

Adverse Outcomes ◽

Factors Associated

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A Pilot Randomized, Controlled Study of Nanocrystalline Silver, Manuka Honey, and Conventional Dressing in Healing Diabetic Foot Ulcer

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2017/5294890 ◽

2017 ◽

Vol 2017 ◽

pp. 1-15 ◽

Cited By ~ 13

Author(s):

Ka-Kit Tsang ◽

Enid Wai-Yung Kwong ◽

Tony Shing-Shun To ◽

Joanne Wai-Yee Chung ◽

Thomas Kwok-Shing Wong

Keyword(s):

Ulcer Healing ◽

Diabetic Foot ◽

Reduction Rate ◽

Foot Ulcer ◽

Diabetic Foot Ulcer ◽

Size Reduction ◽

Controlled Study ◽

Manuka Honey ◽

Ulcer Size ◽

Randomized Controlled

Nanocrystalline silver (nAg) and Manuka honey (MH) dressing have increasing popularity for treating diabetic foot ulcer (DFU). This study was an open-label randomized controlled trial with three parallel groups’ design in examining the preliminary effectiveness of nAg against MH and conventional dressing in healing DFU in terms of ulcer healing, ulcer infection, and inflammation. 31 participants (11 in the nAg group, 10 in the MH group, and 10 in the convention group) diagnosed with type 2 diabetes were enrolled. Wound cleaning, debridement, and topical dressing application were performed according to the group allocation in each visit at weeks 1, 2, 3, 4, 6, 8, 10, and 12. The results found that the proportions of complete ulcer healing were 81.8%, 50%, and 40% in the nAg, MH, and conventional groups, respectively. The ulcer size reduction rate was potentially higher in the nAg group (97.45%) than the MH group (86.21%) and the conventional group (75.17%). In bacteriology, nAg showed a greater rate of microorganism reduction although it was not significant. To conclude, nAg alginate was potentially superior to MH and conventional dressing in healing diabetic foot ulcer in terms of ulcer size reduction rate.

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