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临床试验/DRKS00014744
DRKS00014744已完成未知

Pilot study on the use of neuromuscular stimulation (FlowAid) in patients with therapy-resistant venous leg ulcer - FlowAid

St. Josef- und St. Elisabeth- Hospital gGmbH0 个研究点目标入组 20 人开始时间: 2018年5月17日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
入组人数
20

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
N/a: Single Arm Study
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 one(—)
性别
All

入选标准

  • o Men and women
  • o Age > 18 years
  • o BMI up to 40 kg/m2
  • o Written consent
  • o Patient in the vein centre
  • o Primarily venous ulcer (recurrence or initial manifestation), diagnosis verified by DPPG and duplex sonography
  • o Duration of the wound for at least 3 months
  • o Stable wound progression with no healing tendency despite standard therapy in accordance with guidelines for at least 4 weeks (incl. phase-appropriate wound therapy and sufficient compression therapy)
  • o Possibility and willingness to participate
  • o Reduced mobility in the ankle/arthrogenic congestion syndrome

排除标准

  • o acute TVT/ OVT (< 6 months)
  • o lack of intellectual capacity to agree and answer questions
  • o lack of motor skills or home help for the home use of FlowAid according to the protocol
  • o Contraindications for the use of Flowaid
  • o significant other cause of venous leg ulcer
  • o short-term necessity of in-patient therapy
  • o Pregnancy and lactation
  • o ABI < 0.5 or absolute systolic ankle artery pressure < 60mmHg

研究者

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