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临床试验/NCT03615755
NCT03615755已完成不适用

A Pilot Study of Short Duration Hyperbaric Oxygen Therapy to Improve HbA1c, Leukocyte, and Serum Creatinine in Patient With Diabetic Foot Ulcer Wagner 3-4

Hendry Irawan0 个研究点目标入组 30 人开始时间: 2016年12月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
主要终点
Serum creatinine

研究概览

简要总结

The investigators want to evaluate the short duration HBOT can improve glycohemoglobin (HbA1c) levels, leukocyte count, and serum creatinine levels in patients with DFU (diabetic foot ulcer) Wagner 3-4.

详细描述

This study uses pretest and posttest control group design. All DM (diabetes mellitus) patients with DFU at Sanglah General Hospital, Denpasar who meet the inclusion and exclusion criteria and willing to follow the research procedure. All patients are signing the agreement paper after getting research explanation. All patients were briefed on the study research using HBOT. If the patients are willing to participate in the study and use HBOT was grouped to combination therapy, if the patients are willing to participate in the study but do not want to use HBOT was grouped to standard therapy, but if the patients are not willing participate then excluded.

All patients were taken blood test for HbA1c levels, leukocyte count, and serum creatinine levels before debridement, then grouped for standard therapy or standard therapy with 10 sessions of HBOT. One session of HBOT uses oxygen at 2.4 ATA (atmosphere absolute) for 90 minutes per day at multiplace hyperbaric chamber. This therapy is given five sessions in a week, so it takes two weeks. At the end of therapy, all blood tests were performed again in both groups.

The inclusion criteria were patients who had type 2 diabetes and DFU Wagner class 3 or 4, aged over 18 years, and underwent debridement with or without toe amputation. The exclusion criteria were patients who had severe organs dysfunction such as heart failure, pulmonary infection, pneumothorax, chronic obstructive pulmonary disease, and stroke.

Statistical analysis using SPSS 17.0 (SPSS Inc., Chicago, Illinois, USA). All variables were described before and after treatment. Analysis pretest and posttest values on both groups were used paired T-test and independent T-test. The statistical test results are significant if p < 0.05.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients who had type 2 diabetes and DFU Wagner class 3 or 4, aged over 18 years, and underwent debridement with or without toe amputation.

排除标准

  • patients who had severe organs dysfunction such as heart failure, pulmonary infection, pneumothorax, chronic obstructive pulmonary disease, and stroke.

结局指标

主要结局

Serum creatinine

时间窗: 2 weeks

Serum creatinine levels test before the patients were done debridement (baseline) and after 2 weeks therapy.

HbA1c levels

时间窗: 2 weeks

HbA1c levels test before the patients were done debridement (baseline) and after 2 weeks therapy.

Leukocyte count

时间窗: 2 weeks

Leukocyte count test before the patients were done debridement (baseline) and after 2 weeks therapy.

次要结局

未报告次要终点

研究者

发起方
Hendry Irawan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hendry Irawan

Clinical Research

Udayana University

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