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临床试验/NCT04093635
NCT04093635Unknown不适用

Role of Negative Pressure Wound Therapy in the Management of Diabetic Foot Ulcers

Assiut University0 个研究点目标入组 40 人开始时间: 2019年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
主要终点
Management of diabetic foot ulcers.

研究概览

简要总结

Role of Negative Pressure Wound Therapy in the Management of Diabetic Foot Ulcers

• The aim of this study will be to assess negative pressure wound therapy in treating diabetic foot ulcers.

详细描述

Diabetic Foot ulcers are a major cause of admission in diabetic patients, and comprise a disproportionately high number of hospital days because of multiple surgical procedures and prolonged length of stay in Hospital.

The improvement in diabetes therapy and the reinforcement of guidelines have reduced the amputation rate. The approach to diabetic foot ulcers has allowed the availability of several medical options to ensure the best local condition and wound healing.

Negative-pressure wound therapy is a non-invasive therapy system that employs a 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 container.

An earlier study has shown that NPWT reduced the need for subsequent amputations in a 6-month follow-up period. This reflects the importance of this device in management of DFUs and prevents its complications.

As most of the diabetic wounds present with infection, the success of NPWT is still highly dependent upon the adequacy of surgical debridement and antimicrobial coverage.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Acute and chronic diabetic wounds, pressure ulcers.
  • Wagener's Grade I superficial diabetic ulcer.
  • Wagener's Grade II after surgical debridement and an appropriate antibiotic therapy.
  • Ischemic wounds after revascularization.

排除标准

  • - Wagener's Grade III, osteomyelitis and Charcot's joint septic arthritis.
  • Wagener's Grade IV, localized gangrene e.g. toe ,heel.
  • Wagener's Grade V, extensive gangrene involving the whole foot.
  • Septicemia. .
  • Gas forming organism.
  • Wounds resulting from venous insufficiency.
  • Peripheral vascular disease (absent distal pulse).
  • Patients being treated with corticosteroids, immunosuppressive drugs or chemotherapy
  • Any other serious pre-existing cardiovascular, pulmonary and immunological disease.

结局指标

主要结局

Management of diabetic foot ulcers.

时间窗: one year

Assessment role of negative pressure wound therapy in treating diabetic foot ulcers.

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

Abdelrahman Ibrahim Sayed

Vascular Surgery Department, Assiut University

Assiut University

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