Prospective, single-centre, cohort study assessing the potential application of WOUNDCHEK™ diagnostics for ulcer management

orth Cumbria Integrated Care NHS Foundation Trust0 个研究点目标入组 131 人开始时间: 2023年7月17日最近更新: 2024年7月15日

适应症

试验速览

2024 Results article in https://doi.org/10.1177/15347346241284804 (added 25/09/2024)

•1. Adult patients aged > = 18 years
•2. Patients can be newly presenting to or existing users of the specialist service in question (eg podiatry, vascular surgery)
•3. Patients with recurrent wounds, including multiple wounds, are eligible; largest ulcer to be index wound
•4. If infection occurs and antibiotics applied, whilst in study, then this is not deemed an exclusion criterion.
•5. Prophylactic systemic antibiotic use is not an exclusion criterion
•6. Chronicity: clinical diagnosis of ulcer with wound duration > 30 days.
•7. Wound type:
•7.1. Leg ulcer (can be venous, mixed or arterial in nature)
•7.2. Foot ulcer (can be diabetic or non-diabetic in nature)

•1. Aged < 18 years
•2. Any reasons for the patient being unable to follow the protocol, including lack of mental capacity to consent to taking part in the study.
•3. The patient has concurrent (medical) conditions that in the opinion of the investigator may compromise patient safety or study objectives
•4. Confirmed and ongoing wound infection at baseline which is already being treated with systemic antibiotics.
•5. Previous participation in BIOME study

发起方