Ignite Creation Date:
2025-12-24 @ 12:40 PM
Ignite Modification Date:
2026-01-24 @ 5:55 AM
Study NCT ID:
NCT04249661
Status:
COMPLETED
Last Update Posted:
2023-12-15
First Post:
2020-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Differential Effects of Bacteria Colonising Venous Leg Ulcers on Pain and Healing Rates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014647', 'term': 'Varicose Ulcer'}], 'ancestors': [{'id': 'D014648', 'term': 'Varicose Veins'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Wound swabs will be obtained from the venous leg ulcer from participants and sent to the Microbiology lab for culture and sensitivity testing.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-14', 'studyFirstSubmitDate': '2020-01-16', 'studyFirstSubmitQcDate': '2020-01-29', 'lastUpdatePostDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain burden of venous ulcers colonised by Pseudomonas Aeruginosa', 'timeFrame': '1 year', 'description': '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.'}, {'measure': 'Presentations and Admissions', 'timeFrame': '1 year', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Analgesia Requirements', 'timeFrame': '1 year', 'description': 'Number of participants with pain requiring analgesia will be recorded.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Venous Leg Ulcer']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nIts 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. All patients age 18+ with lower limb venous ulcers as diagnosed on clinical history and examination.\n2. Are willing and capable to voluntarily sign a statement of informed consent to take part in this study.\n3. With an ABPI of \\>/= 0.8 and/or palpable pedal pulses on clinical exam.\n4. Without evidence (either clinical or diagnostic) of other causes of lower limb ulceration, namely vasculitis, local dermopathology, congenital syndromes or arterial insufficiency (see above).\n5. If equipoise or disagreement between two independent clinicians exist, The ultimate decision as to inclusion/exclusion will be made by the P.I\n\nExclusion Criteria:\n\n1. Patients unable to provide informed consent.\n2. Patients under the age of 18\n3. Patients with arterial insufficiency manifesting as ABPI's of \\<0.8\n4. Known or suspected alternate likely primary cause of lower limb ulceration (vasculitis, dermatological disease, underlying congenital syndrome).\n5. Patients who are deemed unsuitable due to any circumstances as deemed appropriate by the P.I."}, 'identificationModule': {'nctId': 'NCT04249661', 'briefTitle': 'Differential Effects of Bacteria Colonising Venous Leg Ulcers on Pain and Healing Rates', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of Limerick'}, 'officialTitle': 'Differential Effects of Bacteria Colonising Venous Leg Ulcers on Pain and Healing Rates', 'orgStudyIdInfo': {'id': 'DVS003'}}, 'contactsLocationsModule': {'locations': [{'zip': 'V94 F858', 'city': 'Limerick', 'country': 'Ireland', 'facility': 'University Hospital Limerick', 'geoPoint': {'lat': 52.66472, 'lon': -8.62306}}], 'overallOfficials': [{'name': 'Eamon Kavanagh, MD FRCSI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Limerick'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of Limerick', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Eamon Kavanagh Prinicipal Investigator', 'investigatorFullName': 'Fiona Leahy', 'investigatorAffiliation': 'University Hospital of Limerick'}}}}