Differential Effects of Bacteria Colonising Venous Leg Ulcers on Pain and Healing Rates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Presentations and Admissions
研究概览
简要总结
This Study aims to identify whether venous leg ulcers which are colonised by Pseudomonas Aeruginosa cause more pain than those which are not and if this bacteria affects healing time. This may determine how venous ulcer infections are treated in order to improve symtomatology and quality of life for patients with these chronic wounds.
详细描述
Pseudomonas is a gram-negative bacillus which commonly colonises lower limb venous ulcers. It produces exotoxins and elastase as well as forming biofilms within chronic wounds.
Its effects on venous ulcer healing are debated. The objective of this study is to examine the effects on Pseudomonas Aeruginosa colonisation on the pain expereinces and healing rates of venous leg ulcers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients age 18+ with lower limb venous ulcers as diagnosed on clinical history and examination.
- •Are willing and capable to voluntarily sign a statement of informed consent to take part in this study.
- •With an ABPI of >/= 0.8 and/or palpable pedal pulses on clinical exam.
- •Without evidence (either clinical or diagnostic) of other causes of lower limb ulceration, namely vasculitis, local dermopathology, congenital syndromes or arterial insufficiency (see above).
- •If equipoise or disagreement between two independent clinicians exist, The ultimate decision as to inclusion/exclusion will be made by the P.I
排除标准
- •Patients unable to provide informed consent.
- •Patients under the age of 18
- •Patients with arterial insufficiency manifesting as ABPI's of <0.8
- •Known or suspected alternate likely primary cause of lower limb ulceration (vasculitis, dermatological disease, underlying congenital syndrome).
- •Patients who are deemed unsuitable due to any circumstances as deemed appropriate by the P.I.
结局指标
主要结局
Presentations and Admissions
时间窗: 1 year
Rates of re-presentation for treatment with respect to underlying wound culture and sensitivity. Number of patient visits to the Vascular Clinic for treatment will be measured.
Pain burden of venous ulcers colonised by Pseudomonas Aeruginosa
时间窗: 1 year
Pain will be examined with respect to underlying microbiota detected by wound culture and sensitivity. The Brief Pain Inventory (Short Form) will be used for assessment purposes.
次要结局
- Analgesia Requirements(1 year)
研究者
Fiona Leahy
Professor Eamon Kavanagh Prinicipal Investigator
University Hospital of Limerick