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临床试验/ACTRN12619001765112
ACTRN12619001765112尚未招募3 期

Evaluating transcatheter arterial embolisation and an anti-inflammatory for improvement of foot pain in people with plantar fasciopathy – a pilot study

Barwon Health0 个研究点目标入组 40 人开始时间: 2019年12月12日最近更新:
适应症

试验速览

阶段
3 期
状态
尚未招募
发起方
Barwon Health
入组人数
40

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
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 85 Years(—)
性别
All

入选标准

  • 1.18 to 85 years of age
  • 2.Moderate to severe plantar heel pain
  • 3.Pain resistant to conservative treatment for at least 3 months
  • a.at least one conventional therapy such as analgesia, NSAID, corticosteroid injection, orthotics, physiotherapy (e.g. stretching and/or strengthening exercises)
  • 4.Willing, able and mentally competent to provide informed consent
  • a.able to read and understand the Patient Information and Consent Form which is written in English language

排除标准

  • 1.Local infection
  • 2.Active malignancy
  • 3.Prior ipsilateral foot or ankle surgery
  • 4.Ipsilateral injection into the foot or ankle in the last 3 months
  • 5.Pregnant or trying to become pregnant during the study period
  • 6.History of allergy to contrast media
  • 7.History of allergy to carbapenem (eg, imipenem, ertapenem or meropenem), or having an immediate or severe hypersensitivity reaction to a penicillin or cephalosporin antibiotic;
  • 8.History of seizures or using valproate
  • 9.History of allergy to NSAIDs
  • 10.Reduced kidney function or failure (chronic or acute)
  • a.Estimated GFR < 30ml/min.1.73m2
  • b.People on dialysis
  • 11.Body weight greater than 200kg
  • 12.Platelets < 100 x 109/L
  • 13.INR > 1.5
  • 14.Moderate to severe pain in other lower limb joints
  • 15.Previous amputation of ipsilateral toe/s or other part of foot
  • 16.Current or previous ipsilateral foot ulcer
  • 17.Peripheral neuropathy lower limb/s
  • 18.Charcot neuroarthropathy
  • 19.Peripheral vascular disease
  • 20.Rheumatoid arthritis or seronegative arthropathies
  • 21.Ipsilateral foot or ankle pain (excluding plantar heel pain) due to conditions such as achilles tendinopathy or Hallux Abduco Valgus
  • 22.Severe hepatic impairment or heart failure
  • 23.Active or a history of gastrointestinal inflammatory disorder or ulceration, haemorrhage, chronic dyspepsia.
  • 24.History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
  • 25.Asthma with known sensitivity to NSAIDs

研究者

发起方
Barwon Health

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