Diagnosis of osteomyelitis: investigation optimisation in diabetic foot ulcers

niversity of Leeds0 个研究点目标入组 4,500 人开始时间: 2021年7月6日最近更新: 2024年8月26日

适应症

试验速览

暂无简介。

•Full clinical cohort:
•1. Aged 18 years or over
•2. Diagnosed with diabetes mellitus (according to WHO criteria)
•3. New active diabetic foot ulcer, as defined by a wound below the malleoli in a person with diabetes
•4. Consent to participate (written/witnessed verbal informed consent)
•High-risk clinical cohorts:
•1. Exhibit one of the following high-risk features for DFO:
•1.1. Clinical infection (IDSA criteria) + positive Probe to Bone (PTB); or
•1.2. Ulcer with area =2 cm²; or
•1.3. Ulcer PTB or
•1.4. Ulcer depth =3 mm; or
•1.5. Dactylitis; or
•1.6. Hard-to-heal” as defined by failure to heal by >50% in the previous 4 weeks
•High-risk phase 2 diagnostic concordance study cohort:
•1. Provide second-level consent for both ‘through-the-ulcer’ and ‘remote’ bone biopsies

•No exclusion criteria for full clinical cohort or phase 1 and 3 high-risk cohorts (as advised by PPI members).
•High-risk phase 2 diagnostic concordance study cohort:
•1. Unable to undergo both ‘through-the-ulcer’ and ‘remote’ bone biopsies
•2. Would not be ethically appropriate to approach the patient e.g. on end of life care

发起方

niversity of Leeds