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

Venous Leg Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04249661
• Other study ID #: DVS003
• Status: Completed
• Start date: January 9, 2020
• Est. completion date: December 14, 2023

Study information

• Verified date: December 2023
• Source: University Hospital of Limerick
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 14, 2023
• Est. primary completion date: December 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

Locations

Country	Name	City	State
Ireland	University Hospital Limerick	Limerick

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Limerick

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Analgesia Requirements	Number of participants with pain requiring analgesia will be recorded.	1 year