Comparison of treatment of Diabetic Foot Ulcers with and without Hyperbaric Oxygen Therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Healing of Diabetic foot ulcer
研究概览
简要总结
A randomized control study of the patients presenting with diabetic foot ulcers will be carried out in the Department of Plastic Surgery, RIMS, Imphal. All the patients with diabetic foot ulcer will be randomly allocated in 2 groups. Group A will undergo treatment with HBOT whereas group B will not. The patients will be studied in terms of the demographic profile to analyse which group of the population is at highest risk for such ulcers. The pattern of ulcer, which includes the duration of ulcer, surface area and site of the ulcer, glycemic status, signs of ischaemia and infection, wagner grading, healing time and rate will also be studied. Last but not the least, the total number of HBOT sessions, changes after HBOT and number of follow up visits required will be noted.
All the findings and observations made during the entire study will be tabulated, graphically depicted whenever possible, statistically analysed and inference drawn to evaluate if there is any relation between a particular group of the population based on gender, occupation or age group, to the healing of ulcer after HBOT and functional outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 8.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •Capacity to make a fully informed decision.
- •Capacity to give consent for treatment.
排除标准
- •Individuals not fit for Hyperbaric Oxygen Therapy.
- •Ulcers less than 1 cm square.
- •Lack of patient’s approval for participation in the trial.
- •Acute ischemia of lower extremity, profound phlebothrombosis, infection that needed generalized antibiotic therapy.
- •Patients having hyperglycemia.
结局指标
主要结局
Healing of Diabetic foot ulcer
时间窗: 6 weeks
次要结局
未报告次要终点
