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NCT06367803 Clinical Trial

Cost Analysis of Vascular Surgical Techniques

Critical Limb Ischemia Clinical Trial

Official title:
Cost Analysis of Vascular Surgical Techniques: Comparing Limb Revascularisation and Amputation in Patients With CLTI at University Hospital Limerick

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06367803
Other study ID # DVS010
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2023
Est. completion date March 1, 2024

Study information
Verified date April 2024
Source University Hospital of Limerick
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

Surgical interventions for patients with CLTI include endovascular revascularisation, by-pass revascularisation and amputation. Clinical outcomes vary greatly for each intervention. The 5-year mortality rate for major amputations i.e., below knee (BKA) and above knee (AKA), is reported to range from 30% to 70%, with AKA having the higher rate of mortality. Concomitant Type II diabetes increases these rates of mortality for both AKA and BKA. Whilst mortality rates 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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date March 1, 2024
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. 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. 2. This analysis will look at cases from a set time frame, that being 1st March 2022 to 1st March 2023. Exclusion Criteria: 1. Cases where CLTI was treated conservatively/without surgical intervention will not be included. 2. Surgical intervention outside of UHL. 3. Cases that occurred outside of the set timeframe.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Ireland University Hospital Limerick Limerick Munster

Sponsors (1)
Lead Sponsor Collaborator
University Hospital of Limerick

Country where clinical trial is conducted

Ireland, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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