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临床试验/NCT06000371
NCT06000371已完成不适用

Cutoff Value of Ankle Brachial Pressure Index for Vacuum Assisted Closure Application in Diabetic Foot Ulcers

Mansoura University1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2020年4月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
1
主要终点
Dimensions of diabetic foot ulcer (manual measurement of length, width and depth of the ulcer by metal ruler).

研究概览

简要总结

Abstract Objective To verify cutoff value of ankle brachial pressure index at which diabetic foot ulcers get benefit from vacuum assisted closure application and to assess impact of its application on ankle brachial pressure index value in the presence of peripheral arterial disease.

Methods An observational descriptive prospective analytic study had been performed.56 patients were enrolled in the study. All patients had three sessions of vacuum-assisted closure application. Debridement was done when indicated. Ulcer dimensions were measured before and after each session, while ankle brachial pressure index was measured before the first session .

详细描述

Introduction Diabetes Mellitus (DM) is a chronic disease, which is considered a global public health problem that leads to major clinical, economic, social, and quality of patient life issues (1). 15% of diabetics will develop a diabetic foot ulcer (DFU) during their lifetime, which is an exceedingly expensive and disabling complication of diabetes mellitus. (2).

Assessment of foot perfusion is a crucial step in treatment of patients with DFU. The ankle-brachial pressure index (ABPI) is a simple, quick, non-invasive tool (3). The key elements of effective DFU management are clinical awareness, appropriate blood glucose levels, regular foot exams, therapeutic footwear that fits the patient, off-loading, local wound care, and the identification and treatment of osteomyelitis and ischemia (4).

Multiple adjuvant therapies have been studied to decrease DFU healing times and amputation rates. These therapies include negative pressure wound therapy (vacuum-assisted closure), non-surgical debridement agents, oxygen therapies, human growth factors, energy based therapies, and systemic therapies(5).Cellular and/ or tissue based product (CTPs) may result in higher average number of ulcer free months and lower average number of amputations and resections compared to standard of care (SOC) alone (6).

Negative pressure wound therapy (NPWT) is a non-invasive therapy that removes fluid from wounds, prepares the wound bed for closure, reduces edema, and promotes the creation and perfusion of granulation tissue by applying regulated negative pressure using a vacuum-assisted closure (VAC) device (7). NPWT is indicated in traumatic, acute wounds, sub-acute wounds (i.e. dehisced incisions), chronic open wounds (stasis ulcers and diabetic ulcers), pressure ulcers, flaps and meshed graft (8).

We conducted this this study to verify cutoff value of ABPI at which diabetic foot ulcers get benefit from VAC application.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • Patient ≥40 years.
  • Unhealed diabetic foot ulcers.
  • Ulcers belonged to grade 1 or grade 2 (in both wound and infection categories "WIFI" classification) .

排除标准

  • Immunocompromised patients.
  • Patient with varicose veins and chronic venous insufficiency.
  • Foot ulcers belonged to grade 3 (in both wound and infection categories of WIFI classification)

结局指标

主要结局

Dimensions of diabetic foot ulcer (manual measurement of length, width and depth of the ulcer by metal ruler).

时间窗: Up to3 weeks

Change of dimensions of diabetic foot ulcers. The higher values mean a worse outcome.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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