Venous Leg UlcerNCT04249661
Differential Effects of Bacteria Colonising Venous Leg Ulcers on Pain and Healing Rates
An observational study of Venous Leg Ulcer, run by University Hospital of Limerick at 1 site in Ireland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer
- How many people
- 100 participants
- Where
- 1 siteIreland
- Study dates
- 9 Jan 2020to 14 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Venous Leg Ulcer
- Medical subject headings
- Varicose Ulcer
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year
Secondary outcomes (1)
Analgesia Requirements
Number of participants with pain requiring analgesia will be recorded.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start9 Jan 2020
- Primary completion14 Dec 2023
- Study completion14 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Limerick
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fiona Leahy, University Hospital of Limerick
- Investigators
- Eamon Kavanagh, MD FRCSI, Principal investigator, University Hospital of Limerick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04249661
- Sponsor's protocol ID
- DVS003
- Status last verified
- Dec 2023
- First submitted
- 16 Jan 2020
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Effects of Bacteria Colonising Venous Leg Ulcers on Pain and Healing Rates
- ClinicalTrials.gov ID
- NCT04249661
- Acronym / sponsor ID
- DVS003
- Conditions
- Venous Leg Ulcer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital of LimerickUniversity, hospital or other
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 14 Dec 2023 (actual)
- Study completion
- 14 Dec 2023 (actual)
- First posted
- 31 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
1 secondary outcome
Analgesia Requirements
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eamon Kavanagh, MD FRCSI principal investigator
University Hospital of Limerick
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Leg Ulcer, run by University Hospital of Limerick at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain burden of venous ulcers colonised by Pseudomonas Aeruginosa (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.