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OpenTrials
Completed

NCT Number: NCT04249661

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Limerick

Limerick, V94 F858, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Pain burden of venous ulcers colonised by Pseudomonas Aeruginosa

    Time frame: 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.

  2. Presentations and Admissions

    Time frame: 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.

Secondary outcomes

  1. Analgesia Requirements

    Time frame: 1 year

    Number of participants with pain requiring analgesia will be recorded.

Sponsors and collaborators

Lead sponsor

University Hospital of Limerick

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 31, 2020
Registry last updated
Dec 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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