Differential Effects of Bacteria Colonising Venous Leg Ulcers on Pain and Healing Rates

Completed

• Conditions: Venous Leg Ulcer

• Registration Number: NCT04249661
• Lead Sponsor: University Hospital of Limerick

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2020-01-09
• Study First Submitted: 2020-01-16
• Study First Submitted QC: 2020-01-29
• Study First Posted: 2020-01-31
• Status Verified: 2023-12
• Primary Completion: 2023-12-14
• Study Completion: 2023-12-14
• Last Update Submitted: 2023-12-14
• Last Update Posted: 2023-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. All patients age 18+ with lower limb venous ulcers as diagnosed on clinical history and examination.
2. Are willing and capable to voluntarily sign a statement of informed consent to take part in this study.
3. With an ABPI of >/= 0.8 and/or palpable pedal pulses on clinical exam.
4. Without evidence (either clinical or diagnostic) of other causes of lower limb ulceration, namely vasculitis, local dermopathology, congenital syndromes or arterial insufficiency (see above).
5. If equipoise or disagreement between two independent clinicians exist, The ultimate decision as to inclusion/exclusion will be made by the P.I

Exclusion Criteria

1. Patients unable to provide informed consent.
2. Patients under the age of 18
3. Patients with arterial insufficiency manifesting as ABPI's of <0.8
4. Known or suspected alternate likely primary cause of lower limb ulceration (vasculitis, dermatological disease, underlying congenital syndrome).
5. Patients who are deemed unsuitable due to any circumstances as deemed appropriate by the P.I.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presentations and Admissions	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	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.

Secondary Outcome Measures

Name	Time	Method
Analgesia Requirements	1 year	Number of participants with pain requiring analgesia will be recorded.

Trial Locations

Locations (1)

University Hospital Limerick; 🇮🇪 Limerick, Ireland