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

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.

Study Overview

• Status: Completed
• Conditions: Venous Leg Ulcer

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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Ireland
  • Limerick, Ireland, V94 F858
    • University Hospital Limerick

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Vascular patients with new and old venous ulcers to their lower limbs. As deemed suitable as per the inclusion/exclusion criteria. As deemed suitable by the P.I.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain burden of venous ulcers colonised by Pseudomonas Aeruginosa	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.	1 year
Presentations and Admissions	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgesia Requirements	Number of participants with pain requiring analgesia will be recorded.	1 year

Collaborators and Investigators

• Sponsor: University Hospital of Limerick
• Investigators: Principal Investigator: Eamon Kavanagh, MD FRCSI, University Hospital of Limerick

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2020
• Primary Completion (Actual): December 14, 2023
• Study Completion (Actual): December 14, 2023

Study Registration Dates

• First Submitted: January 16, 2020
• First Submitted That Met QC Criteria: January 29, 2020
• First Posted (Actual): January 31, 2020

Study Record Updates

• Last Update Posted (Actual): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: DVS003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No