ClinicalTrials.gg
CompletedNCT04249661Updated Dec 15, 2023

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

An observational study in Venous Leg Ulcer, sponsored by University Hospital of Limerick. Completed at 1 site in Ireland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-15.

Sponsored by University Hospital of Limerick · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Venous Leg Ulcer

Browse trials for

03

In context

Varicose Ulcer

384 studies on the registry are indexed under Varicose Ulcer; 80 are open to participants now.

This study's enrollment of 100 is below the median of 150 across 41 observational studies indexed under Varicose Ulcer.

Browse Varicose Ulcer studies →

Lead sponsor

University Hospital of Limerick is the lead sponsor of 16 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year

  2. 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.

    Time frame: 1 year

Secondary outcomes

  1. Analgesia Requirements

    Number of participants with pain requiring analgesia will be recorded.

    Time frame: 1 year

07

Study locations

1 site
  • University Hospital Limerick
    Limerick, V94 F858, Ireland
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2020 to primary completion in Dec 2023, 47 months.

Of 23 observational studies under Varicose Ulcer, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 16. This study's 47 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 16, 2020
First posted
Jan 31, 2020
StartActual
Jan 9, 2020
Primary completionActual
Dec 14, 2023
CompletionActual
Dec 14, 2023
Last update
Dec 15, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04249661
Lead sponsor
University Hospital of Limerick
Responsible party
Fiona Leahy (Professor Eamon Kavanagh Prinicipal Investigator, University Hospital of Limerick) — Principal investigator
First posted
Jan 31, 2020
Start date
Jan 9, 2020
Primary completion
Dec 14, 2023
Completion
Dec 14, 2023
Last update
Dec 15, 2023

Study contacts

Eamon Kavanagh, MD FRCSI
principal investigator · University Hospital of Limerick

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion