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临床试验/CTRI/2025/04/085506
CTRI/2025/04/085506尚未招募不适用

Comparison of treatment of Diabetic Foot Ulcers with and without Hyperbaric Oxygen Therapy

Subrata Choudhury1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2025年6月5日最近更新:

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

研究者

发起方
Subrata Choudhury
申办方类型
Other [self]

研究点 (1)

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