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

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.

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

2021 ◽  
pp. 153473462110334
Author(s):  
Aditya Dutta ◽  
Anil Bhansali ◽  
Ashu Rastogi
Keyword(s):  
Cohort Study ◽  
Blood Glucose ◽  
Glycemic Control ◽  
Ulcer Healing ◽  
Diabetic Foot ◽  
Foot Ulcer ◽  
Diabetic Foot Ulcer ◽  
Postprandial Blood Glucose ◽  
Ulcer Area ◽  
Intensive Glycemic Control

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.

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

2017 ◽  
Vol 2017 ◽  
pp. 1-15 ◽  
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.

Glucose control and infection of diabetic foot ulcer

2020 ◽  
pp. 107772
Author(s):  
Amélie Simoneau ◽  
Saad Rojubally ◽  
Kamel Mohammedi ◽  
Marie Monlun ◽  
Ninon Foussard ◽  
...  
Keyword(s):  
Diabetic Foot ◽  
Glucose Control ◽  
Foot Ulcer ◽  
Diabetic Foot Ulcer

scholarly journals Glycemic control and diabetic foot ulcer outcomes: A systematic review and meta-analysis of observational studies

2020 ◽  
Vol 34 (10) ◽  
pp. 107638 ◽  
Author(s):  
Kyrstin L. Lane ◽  
Mohammed S. Abusamaan ◽  
Betiel Fesseha Voss ◽  
Emilia G. Thurber ◽  
Noora Al-Hajri ◽  
...  
Keyword(s):  
Systematic Review ◽  
Glycemic Control ◽  
Diabetic Foot ◽  
Observational Studies ◽  
Meta Analysis ◽  
Foot Ulcer ◽  
Diabetic Foot Ulcer

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

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.

scholarly journals The risk factors of developing diabetic foot ulcers incidence with diabetic patients in Mukalla/Yemen

2020 ◽  
Author(s):  
مريم باراس ◽  
Eidha A. Bin Hameed
Keyword(s):  
Diabetes Mellitus ◽  
Risk Factors ◽  
Blood Glucose ◽  
Bacterial Infection ◽  
Diabetic Foot ◽  
Age Groups ◽  
Foot Ulcer ◽  
Diabetic Foot Ulcer ◽  
Diabetic Patients ◽  
Patients With Diabetes

Background: Diabetes is on the rise worldwide and is already considered as an epidemic by some experts. So, there is a need to raise awareness on the important factors that can help prevent bacterial infection in wounds of patients with diabetes. Objective: To study the risk factors of developing diabetic foot ulcer (DFU) in patients with diabetes. The study is the first in Yemen to investigate the prevalence of bacterial infection in wounds of diabetic patients. Materials and Methods: This is a case-control study carried out from November 2018 to May 2019. Twenty diabetic patients with foot ulcer and twenty without foot ulcer were examined. Risk factors and clinical profile of patients were studied by using a standardized questionnaire that included gender, age groups, past history of diabetes, duration of the disease, type of diabetes, DFU, type of ulcer, smoking, glucose level, and control of blood glucose level. Results: The risk factors that affected significantly the occurrence of DFU were gender (0.038), age groups (0.010), and duration of diabetes mellitus (DM) while hyperglycemic control, smoking, and family history were not. There was no significant difference (0.977) in mean fasting blood glucose (MBG) between the DM and DFU patients. Conclusions: Male diabetic patients aged more than 55 years and suffering from DM for more than 10 years were most likely to have DFU. Key words: diabetic foot ulcer, diabetes mellitus, risk factors, Yemen 

scholarly journals Clinical study in management of infected diabetic foot ulcers: superoxidised solution versus povidine iodine solution

2018 ◽  
Vol 5 (7) ◽  
pp. 2406
Author(s):  
Ramalingeshwara Kantly ◽  
Abhijit Medikeri
Keyword(s):  
Diabetic Foot ◽  
Foot Ulcer ◽  
Diabetic Foot Ulcer ◽  
Controlled Study ◽  
Solution Versus ◽  
Ulcer Area ◽  
Group A ◽  
The Mean ◽  
Group B ◽  
Povidine Iodine

Background: Diabetic foot ulcer is a one of the major challenging problem to every surgeon in day to day practice. Superoxidised solution is an effective concept in the wound management. The present study was aimed to compare the efficacy of dressings with superoxidised solution versus povidine iodine in the management of infected diabetic ulcers.Methods: This is a randomized controlled study conducted over a period of one year. In our study, total of 60 patients presenting with infected diabetic ulcers are included. Patients were randomly divided into two groups of 30 each, group A (Topical superoxidised solution dressing) and group B (Topical povidine iodine dressing). Wound was observed for decrease in size of the ulcer, granulation, tissue quality and discharge from the wound at the end of each week for two weeks.Results: In the present study, 76.67% of patients in group A and B were males and the male to female ratio was 3.2:1. The mean age in group A was 55.90±14.27 years compared to 51.50±13.18 years in group B. The mean initial ulcer area in group A was 3882±1890 mm2 compared to 3992±2000 mm2 in group B. The mean post treatment final area in group A was significantly low (1607±862 mm2) compared to group B (2351±1240 mm2; p=0.009) and the comparison of mean change in ulcer area was significantly high in group A compared to group B (2215±1060 mm2 vs 1641±856 mm2; p=0.024). The mean percentage reduction in ulcer area among patients with group A was significantly high (58.90±5.21 percent vs. 40.90±8.76 percent; p=0.024). The commonest organism isolated in group A was Escherichia coli (26.67%) and in group B, it was staphylococcus. The culture was positive in 26% of the patients in group A compared to 50% in group B (p=0.063).Conclusions: Overall, topical superoxidised solution dressing for diabetic foot ulcer accelerated the healing process resulting in faster recovery through reduction in ulcer area compared to topical povidine iodine dressing.

scholarly journals Risk factors of amputation in diabetic foot infections

2018 ◽  
Vol 5 (4) ◽  
pp. 1399 ◽  
Author(s):  
Quraysh Shabbir Sadriwala ◽  
Bapuji S. Gedam ◽  
Murtaza A. Akhtar
Keyword(s):  
Risk Factors ◽  
Peripheral Neuropathy ◽  
Glycemic Control ◽  
Diabetic Foot ◽  
Foot Ulcer ◽  
Diabetic Foot Ulcer ◽  
Poor Glycemic Control ◽  
Diabetic Patients ◽  
Factors Associated ◽  
Diabetic Foot Infections

Background: Diabetes is the most common underlying cause of foot ulcers, infection, and ischemia, leading to hospitalization and the most frequent cause of non-traumatic lower extremity amputation. Despite well-defined risk factors for diabetic foot ulcer development, limited data are available as to which factors predict amputation in a diabetic foot ulcer episode. Therefore, to predict lower limb amputation occurrence and to determine the factors associated with the risk of amputation in diabetic patients, we conducted this study.Methods: A hospital based longitudinal study was carried out to assess the risk factors associated with amputation in diabetic foot infection. Patients with foot infections, who were either a diagnosed case of diabetes mellitus or were diagnosed at the institute were included in the study. We excluded patients receiving immunosuppressive therapy or radiotherapy, and infections at or above the ankle joint. Study factors were demographic details, biochemical parameters, Wagner grading, peripheral neuropathy as evaluated by nerve conduction test and vasculopathy as assessed by Ankle brachial index. The primary outcome factor was amputation. The data was presented as descriptive statistics and analyzed by dividing the patients into amputation and non-amputation group, and univariate and multivariate analysis was done.Results: A total of 64 patients were included in the study, out of which the amputation rate was 39.1%. Poor glycemic control, osteomyelitis, vasculopathy, peripheral neuropathy and Wagner grading were statistically significant.Conclusions: In the present study, poor glycemic control, vasculopathy, peripheral neuropathy and higher Wagner grade are significant risk factors for amputation in diabetic foot infections.

scholarly journals Clinical and Economic Assessment of Diabetic Foot Ulcer Debridement with Collagenase: Results of a Randomized Controlled Study

2013 ◽  
Vol 35 (11) ◽  
pp. 1805-1820 ◽  
Author(s):  
Arthur Tallis ◽  
Travis A. Motley ◽  
Robert P. Wunderlich ◽  
Jaime E. Dickerson ◽  
Curtis Waycaster ◽  
...  
Keyword(s):  
Diabetic Foot ◽  
Foot Ulcer ◽  
Diabetic Foot Ulcer ◽  
Economic Assessment ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Randomized Controlled

scholarly journals Quality of Life and Associated Factors in Indonesian Diabetic Patients with Foot Ulcers

2018 ◽  
Vol 8 (1) ◽  
pp. 13 ◽  
Author(s):  
Yunita Sari ◽  
Iwan Purnawan ◽  
Agis Taufik ◽  
Annas Sumeru
Keyword(s):  
Quality Of Life ◽  
Blood Glucose ◽  
Diabetic Foot ◽  
Associated Factors ◽  
Foot Ulcer ◽  
Diabetic Foot Ulcer ◽  
Care Plan ◽  
Diabetic Patients ◽  
Cross Sectional

Background: Diabetic foot ulcer will cause a reduction in quality of life (QOL), high care burden, and even mortality. An assessment of QOL and associated factors in patients with diabetic foot ulcer is important to provide evidence for establishing a care plan program for such patients. However, up to the present, there is no evidence of a published study that investigates the QOL and its associated factors in patients with diabetic foot ulcer in Indonesia.Purpose: The purpose of this study was to investigate the QOL in patients with diabetic foot ulcer in each domain and investigate the factors associated with this condition.Methods: The design of this study was a cross-sectional study. The total sample for this study was 55 patients. The QOL data were collected using a Diabetic Foot Ulcer Scale questionnaire. Statistical analyses were conducted using Mann-Whitney U-test and Kruskal-Wallis test.Results: The result showed that the QOL in the domains of emotions, positive compliance, family life, and friend were high, while the QOL in the domains of daily activities, physical health, leisure, finances, positive attitude, and treatment ranged from low to average. Significant differences were found between income (p=0.004), grade of the wound (p=0.047), number of wounds (p=0.029), and blood glucose (p=0.013) with QOL of patients. Other variables did not have a significant relationship with QOL, but marital status had a significant correlation with the domain of leisure (p=0.004) and duration of the ulcer had a significant correlation with the domain of emotions (p=0.001)Conclusion: There is a correlation between income, grade of the wound, the number of wounds, and blood glucose with QOL of patients with a diabetic foot ulcer. This study recommends to take into account economic status, grade and number of wound, and blood glucose level in order to improve the QOL of patients for an effective patient care plan.

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