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临床试验/NCT04058639
NCT04058639招募中不适用

Diabetic Foot Ulcers: Shorter Treatment Period Using Custom Felt Relief?

Helse Møre og Romsdal HF1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2019年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
74
试验地点
1
主要终点
wound healing time in weeks

研究概览

简要总结

The Surgical Outpatient Clinic at Molde Hospital has since 2015 offered specialized treatment for patients with diabetic foot ulcers. This treatment is given by an interdisciplinary diabetic foot ulcer team. The standard treatment for diabetic foot ulcers is relief, a method with good results.

Although the treatment as usual gives good results, the team wants to optimize this treatment. By using custom felt relief for each patient, the treatment period might be reduced considerably. The aim of this study is therefore to investigate whether custom felt relief gives shorter processing time compared to standard relief treatment.

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
45 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •diagnosed with Diabetes Mellitus Type 1 or 2
  • •has neuropathic wounds under the foot
  • •understands and speaks Norwegian well
  • •competent to give consent

排除标准

  • •responds to the filament glue and/or the tape used in treatment
  • •in need of vascular surgery intervention
  • •to be admitted to the hospital
  • •in need of intravenously administered antibiotics due to wound infection.

研究组 & 干预措施

felt relief

Experimental

"custom felt relief"

干预措施: "custom felt relief" (Procedure)

treatment as usual

Active Comparator

standard treatment usually provided by the Surgical Outpatient Clinic

干预措施: standard relief treatment (Procedure)

结局指标

主要结局

wound healing time in weeks

时间窗: 2-8 weeks

from the patients first visit (when the first felt dressing is applied) until the wound is healed

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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