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

NCT04249661 | Completed

• 1 other identifier: DVS003
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Venous Leg Ulcer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Analgesia Requirements

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital of Limerick: lead

Study Sites (1)

University Hospital Limerick

Limerick, V94 F858, Ireland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Wound swabs will be obtained from the venous leg ulcer from participants and sent to the Microbiology lab for culture and sensitivity testing.

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Eamon Kavanagh, MD FRCSI

  University Hospital of Limerick

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Eamon Kavanagh Prinicipal Investigator

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: January 31, 2020
• Study Start: January 9, 2020
• Primary Completion: December 14, 2023
• Study Completion: December 14, 2023
• Last Updated: December 15, 2023

Record last verified: 2023-12

Locations

IE (1)