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临床试验/NCT06153953
NCT06153953尚未招募不适用

A Comparative Study Between Vacuum Therapy Dressing and Conventional Dressing in Management of Diabetic Wounds

Sohag University0 个研究点目标入组 100 人开始时间: 2023年12月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
duration of healing

研究概览

简要总结

Diabetes is a global epidemic and a leading cause of death by disease. An estimated 366 million people worldwide had diabetes in 2011.(1).The incidence of diabetic foot ulcers (DFUs) and diabetic complications increases as the age increases.(2).Up to 25% of patients with diabetes will suffer from a foot ulcer during their lifetime. Ulceration is a pivotal factor in the causal pathway to infection and amputation.(3,4).Diabetic foot ulcers (DFUs) are the main cause of hospitalization in diabetic patients and they are considered a worldwide health problem. In recent years, the improvement in diabetes therapy and the reinforcement of guidelines have reduced the amputation rate.(5).The etiology of DFU is complex and rarely unifactorial. In general, foot ulcers are the cumulative result of repetitive trauma that wears a hole in the skin. The triad of neuropathy, foot deformity, and minor considers as the major contributing factors of ulcer development.(6).Vacuum therapy or Negative Pressure Wound Therapy is a technology uses a piece of foam in contact with the wound bed, covered by an occlusive dressing and placed under sub atmospheric pressure.(7).In other words NPWT is a non-invasive therapy system that uses controlled negative pressure using a vacuum device to promote wound healing by removing fluid from open wounds through a sealed dressing or a foam dressing connected to a collection container using sub-atmospheric pressure.(8).The system produces granular tissue that has a characteristic rough appearance. The device can decrease the depth and area of large diabetic foot wounds into a shallow, smaller wound.(8,9).NPWT was first proposed by Argenta and Morykwas in 1997. From then it has been approved as an effective modality of dressing in chronic wounds.(1).NPWT is a safe modality of dressing it has shown a few complications. Minor complications encountered in the vacuum-treated patients : erosion of adjacent tissue due to increased local pressure underneath the tubing ,mild reactions of the peri-wound area (i.e. maceration and eczema) , and sudden increase in body temperature.(10)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
15 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients with diabetic non ischemic wounds which match the criteria suitable for the procedure.

排除标准

  • • Patients with chronic limb ischemia non-palpable distal pulsation.
  • Lack of good hemostasis in the wound.
  • Patients with malignant ulcers.
  • Hepatic patients and patients receiving radio or chemotherapy.
  • Wounds over untreated osteomyelitis.
  • Wounds with fistulae to organs or body cavities.
  • Presence of necrotic tissue.
  • Exposed arteries/nerves/anastomotic site/organ

结局指标

主要结局

duration of healing

时间窗: 6 months

healing progress

次要结局

未报告次要终点

研究者

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

Mohsen Ahmed Atta

resident- vascular surgery- sohag university hospital

Sohag University

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