The Effect of Intensive Versus Conventional Glycemic Control in Diabetic Foot Ulcer Healing: a Randomised Control Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of participants with complete wound closure (epithelialisation) at 12 weeks in both intensive and conventional treatment groups.
研究概览
简要总结
Diabetic foot ulcer is one of the most serious, most costly and at times life threatening complication of diabetes. The lifetime incidence of foot ulcer occurrence in diabetes is up to 25%. Despite the advent of numerous types of wound dressings and off-loading mechanisms, the ulcer healing rates in diabetes have remained dismally low. Hyperglycemia impairs the inflammatory, proliferative and remodeling phases of an ulcer. There are retrospective studies linking improvement of HbA1c to wound area healing rate. The investigators hypothesised that intensive glycemic control in a patient of diabetic foot ulcer improves the healing process. To explore this hypothesis, the investigators are conducting this randomized control trial with the primary aim of wound healing in patients of diabetic foot ulcer on either intensive glycemic treatment or conventional (pre-existing) glycemic treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •Patients of DM according to ADA guidelines
- •HbA1c >8% and/or FBG >130 on 3 consecutive occasions
- •DFU: Wagner grade 2 & 3 or UTS 2-3B
- •Duration of ulcer <12 weeks
- •Wound size: >1cm2
- •Willingness to sign consent form & participate in the study
- •Capacity to attend visits at hospital for review
排除标准
- •Diagnosis with unpredictable healing ability e.g. malignancy, depression, HIV, CTD, steroid use
- •Dialysis requiring CKD & eGFR <30 ml/min
- •Active Charcot foot
- •PEDIS 4: life threatening DFU
- •ABI <= 0.7
- •Refusal to give informed consent
研究组 & 干预措施
Intensive
New anti-diabetic drug regimen with (mandatory) Insulin >= 3 times per day
干预措施: Insulin (Drug)
结局指标
主要结局
Number of participants with complete wound closure (epithelialisation) at 12 weeks in both intensive and conventional treatment groups.
时间窗: 12 weeks
Ulcer area to be measured by Wound Measurement Camera model WZ2.0 (bought from (Wound zoom incorporate, 2916, Borham Ave, Stevens Point, W1, USA 54481) at baseline, 4 and 12 weeks.
次要结局
- Change in ulcer severity- Wagner and UTWSC classification.(4 and 12 weeks)
- Percent reduction in ulcer area (from baseline) at 4 & 12 weeks in both intensive and conventional treatment groups.(4 and 12 weeks)
- HbA1c at 4 & 12 weeks in both intensive and conventional groups.(4 and 12 weeks)
- Incidence of any amputation.(4 and 12 weeks)
研究者
Ashu Rastogi
Assistant Professor, Department of Endocrinology
Post Graduate Institute of Medical Education and Research, Chandigarh