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临床试验/NCT04834232
NCT04834232Unknown不适用

Comparative Study Between Iliac Vein Stenting and Compression Therapy in Recurrent Venous Ulceration

Assiut University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
ulcer healing within 6 months

研究概览

简要总结

Comparing the result of of iliac vein stenting and compression therapy in management of recurrent venous ulceration.

详细描述

Venous ulceration is the most common etiology of lower extremity ulceration, approximately affecting almost 1% of the world's population. although its overall prevalence is relatively low, the refractory nature of venous ulceration increases morbidity, mortality , the patient's quality of life, and have a significant financial burden on the global budget. the primary risk factors are: old age, obesity deep venous thrombosis, phlebitis and previous leg injuries.

Iliac vein compression is a prevalent finding in patients with venous system pathology. It has a variety of causes, including May-Turner syndrome, endometriosis, bladder distension, common iliac artery aneurysm or internal iliac artery aneurysm.

venous compression becomes clinically significant when there's an increase in venous pressure, which in turn causes venous insufficiency. This contributes to the development of a state of chronic venous stasis, which sequentially causes pooling of blood, triggers further capillary damage and activates inflammatory mediators with the end result of venous ulcer development and impaired wound healing.

Located on bony prominences, venous ulcers are typically shallow, irregular with granulation tissue and fibrin present in their bases. A careful physical examination is required for a proper diagnosis, but he clinical challenge remains in its management, which includes prevention or the treatment of the clinical implications.

Treatment modalities should always be directed to the cause of the ulcer; they can be divided into:

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
12 Years 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • iliac vein compression.
  • competent superficial venous system.
  • isolated iliac vein lesion.
  • patent femoropopliteal segment.
  • ulcers located in the gaiter area.
  • age > 12 years
  • patients with ulcers located in the gaiter area, along with the following associated symptoms: leg heaviness, pain, varicose veins, edema, hemosedrin staining, pruritus, venous dermatitis, lipodermatoscelrosis, telangiectasias, corona phlebectatica, atrophie blanche and deformity of the leg.

排除标准

  • patients with arterial disease in the same limb.
  • patients with history of phlebitis.
  • patients with congenital venous malformation
  • patients with malignancy.
  • patients with raised renal chemistry.
  • patients with skin allergy.
  • diabetic neuropathic ulcer.
  • atypical site of venous ulcer.
  • acute onset DVT.
  • age < 12 years.

结局指标

主要结局

ulcer healing within 6 months

时间窗: baseline

comparing the results of both modalities in recurrent venous ulcer healing

次要结局

  • compliance(baseline)
  • patency on stents(baseline)
  • assessment of venous clinical severity score(baseline)
  • assessment of venous disability score (VDS)(baseline)

研究者

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

Mohamed hesham abdelrahem husiein

principal investigator

Assiut University

研究点 (1)

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