NCT06367803

Brief Summary

Whilst mortality rates and surgical limitations are widely known and understood for each intervention performed, the cost implications, in UHL, are not known. Therefore, it is deemed a matter of interest to understand these costs and weigh them against the mortality rates for each intervention if available.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 11, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 16, 2024

Completed
Last Updated

May 4, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

April 11, 2024

Last Update Submit

April 30, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • A comparative assessment of the cost implications of the surgical modalities used in the treatment of CLTI i.e., revascularisation and amputation.

    A comparative assessment of the cost implications of the surgical modalities used in the treatment of CLTI i.e., revascularisation and amputation.

    2 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who have been diagnosed with CLTI and are under the care of a Vascular Surgeon at University Hospital Limerick

You may qualify if:

  • Cases where CLTI was treated surgically by a Vascular Consultant at UHL will be included in this analysis. That being individuals who underwent revascularisation procedures and/or lower limb amputation.
  • This analysis will look at cases from a set time frame, that being 1st March 2022 to 1st March 2023.

You may not qualify if:

  • Cases where CLTI was treated conservatively/without surgical intervention will not be included.
  • Surgical intervention outside of UHL.
  • Cases that occurred outside of the set timeframe.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Limerick

Limerick, Munster, Ireland

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial DiseaseAtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsIschemia

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 11, 2024

First Posted

April 16, 2024

Study Start

June 1, 2023

Primary Completion

December 1, 2023

Study Completion

March 1, 2024

Last Updated

May 4, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

This project has been written up for submission to an Irish Medical Journal

Locations