https://doi.org/10.1177/1534734620952245 The International Journal of Lower Extremity Wounds 1–7 © The Author(s) 2020 Article reuse guidelines: sagepub.com/journals-permissions DOI: 10.1177/1534734620952245 journals.sagepub.com/home/ijl Original Article Introduction According to the International Diabetic Federation, there will be over 642 million people with diabetes in the world by 2040 and most in southeast Asia including India. 1 Foot complications including diabetic foot ulcer (DFU) are one of the serious but neglected complication of diabetes with a lifetime incidence up to 25% 2 and prevalence rates of 4% to 27% in people with diabetes. 3-5 One fifths of hospital admis- sions in people of diabetes are accounted by nonhealing DFU as a consequence of foot infection or gangrene. 6 The healing rates of neuropathic DFU remains dismal low despite advances in wound management as only 1 in 4 DFU receiving good wound care heal over 12 weeks and one third at 20 weeks. 7-9 Nonhealing DFU (15% of overall DFU) consequently lead to lower extremity amputation (LEA), and almost two thirds of all LEA occur as a result of DFU. 7,8 Unfortunately, DFU also contributes to a higher 952245IJL XX X 10.1177/1534734620952245The International Journal of Lower Extremity WoundsRastogi et al research-article 2020 1 Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India 2 IPGME&R, Kolkata, India 3 Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India 4 Amrita Institute of Medical sciences, Kochi, Kerala, India 5 All India Institute of Medical Sciences (AIIMS), Raipur, India 6 Max Hospitals, New Delhi, India 7 Raheja Hospital, Mumbai, Maharashtra, India Corresponding Author: Ashu Rastogi, Department of Endocrinology, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh 160012, India. Email: ashuendo@gmail.com Intensive Glycemic Control for Diabetic Foot Ulcer Healing: A Multicentric, Randomized, Parallel Arm, Single-Blind, Controlled Study Protocol (INGLOBE Study) Ashu Rastogi, MD, DM 1 , Satinath Mukhopadhyay, DM 2 , Jay Prakash Sahoo, DM 3 , Arun Mennon, MD 4 , Amritava Ghosh, DM 5 , Sujjet Jha, MD 6 , and Arun Bal, MS 7 Abstract 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. Keywords diabetic foot ulcers, lower extremity wound, diabetic foot, wound healing, intensive glycemic control, diabetic neuropathy