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临床试验/NCT04461132
NCT04461132已完成不适用

Investigation of the Effect of Manual Lymphatic Drainag on Venous Ulcer Healing Rate

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年9月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
试验地点
1
主要终点
Evaluation of pain

研究概览

简要总结

In venous ulcer, venous insufficiency is accompanied by lymphatic insufficiency. Manual lymphatic drainage (mld) technique cause to increase contraction rate of lymphatic collector and venous flow. It is known that Manual lymphatic drainage accelerates microcirculation, enabling nutrients and oxygen to reach tissues and at the same time removing residual substances from the tissue. We hypothesis that if we inrease to lypmhatic activity with MLD, we could stimulate healing of ulcer. The aim of this study to investigate the effect of manual lymphatic drainage on venous ulcer healing.

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • with venous ulcer unhealing for at least 6 weeks
  • Without enfection
  • vascular surgery is not indicated
  • There is no obstruction to apply MLD and compression to lower extremty

排除标准

  • with diabetic mellutus
  • with enfection
  • with ABI<0,7
  • Patients who have undergone venous vascular surgery
  • Patients undergoing active wound closure treatment

结局指标

主要结局

Evaluation of pain

时间窗: Change from baseline pain following the end of treatment (12. treatment session) and 1 month after the end of treatment.

Pain was evaluated by Visual Analog Scale between 0 (no pain)-10 (extreme) pain.

Evaluation of wound healing

时间窗: Change from baseline wound healing following the end of treatment (12. treatment session) and 1 month after the end of treatment.

Wound was assesed by analyzing photographes of wound with Tracker software.

Evaluation of range of motion of ankle

时间窗: Change from baseline range of motion following the end of treatment (12. treatment session) and 1 month after the end of treatment.

range of motion of ankle was measured with goniometer

evaluation of edema

时间窗: Change from baseline edema following the end of treatment (12. treatment session) and 1 month after the end of treatment.

edema was measured by 3D scanner

evaluation of quality of life

时间窗: Change from baseline quality of life following scores the end of treatment (12. treatment session) and 1 month after the end of treatment.

quality of life was evaluated by SF- 12

次要结局

未报告次要终点

研究者

发起方
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
申办方类型
Other
责任方
Sponsor

研究点 (1)

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