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临床试验/NCT04561609
NCT04561609已完成不适用

The Effect of Transcutaneous Application of Gaseous CO2 on Diabetic Chronic Wound Healing

University Medical Centre Ljubljana3 个研究点 分布在 2 个国家目标入组 120 人开始时间: 2023年5月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
3
主要终点
Ratio of completely healed wounds

研究概览

简要总结

The research is designed to evaluate influence of transcutaneous application of CO2 (carbon dioxide) on chronic wound healing. Transcutaneous application of CO2 is known to have immediate effect on vasodilatation and elevates oxygen release from Hb via the Bohr effect. After repetition of the therapies neoangiogenesis is induced. Impairment of microcirculation is one of the causes of impared wound healing and improvement in circulation could have positive effect on wound healing, reduction of the wound area and granulation of the wound bed (Falanga score).

详细描述

Transcutaneous application of gaseous CO2 showed to be a successful adjuvant therapy in treatment of chronic wounds in diabetic patients (PMID: 32633896). In this intervention technique, therapeutic concentrations of medical-grade CO2 are applied to the skin's surface in a safe, non-invasive manner. The main therapeutic mechanism is derived from the human body's natural response to locally increased CO2 concentration. Because vasodilatory capacity is impaired in diabetic foot, these mechanisms enhance local microvascular perfusion, thereby improving tissue oxygenation in patients with DFUs. Furthermore, although the researchers primarily focus on CO2 therapy as an intervention method, its efficacy is also suggested in preventing DFUs. We plan to enrole 120 patients, 80 into the study arm that will recieve CO2 therapy and 40 for a control group wothout CO2 therapy. All 120 patienrs will receive standard wound care. Aditionally, only study group will receive 20 treatments with CO2 (each workday for 4 weeks). Lower part of the body will be inserted into therapeutic wrap that is filled with 99.9% CO2 gas for 50 minutes. In both groups investigator will evaluate wound status (size, Falanga score of the wound bed) before first and after 4 weeks of treatment. Main outcome measure will be ratio of the completely heald wounds, reduction of the wound size in non healed wounds and status of the wound bed in non healed wounds after 4 weeks of treatment. Possible side effects of the CO2 therapy will be monitored.

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 (Participant, Investigator, Outcomes Assessor)

盲法说明

Patients will not know to which group they belong. They will all receive treatment (study group with CO2, control group with air), the nurse who will prepare the gas for treatment will know the group belonging for the patient. The investigator, who will evaluate neuropathy before and after treatment will not know the group belonging of the patient. At the end, the person evaluating the results will compare results from 2 groups, not knowing which one was study and which control.

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • confirmed diagnosis of DM Type 1 or Type 2,
  • confirmed diagnosis of a non-healing DFU without clinical signs of infection,
  • being able to provide informed consent for the participation, and

排除标准

  • patients with severe comorbidities: deep vein thrombosis, chronic kidney diseases grade III and IV, chronic heart diseases NYHA (New York Heart Association) III and IV, patients with known malignant diseases, patients with progressive infection, signs of systemic infection with elevated inflammatory markers or osteomyelitis

研究组 & 干预措施

CO2 treated

Active Comparator

Patients receiving treatment with transcutaneous application of gaseous CO2 on lower limbs

干预措施: Transcutaneous CO2 application (Other)

control

No Intervention

Patients receiving standard of care

结局指标

主要结局

Ratio of completely healed wounds

时间窗: after 4 weeks of therapy with CO2 or standard of care

The ratio of the completely healed wounds without exudate on 2 consecutive visits

次要结局

  • reduction of the wound size of the unhealed wounds(after 4 weeks of therapy with CO2 or standard of care)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Helena Ban Frangez

assistant professor MD, PhD

University Medical Centre Ljubljana

研究点 (3)

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