Status:
UNKNOWN
Carnosine for Peripheral Vascular Disease
Lead Sponsor:
Monash University
Collaborating Sponsors:
Monash Health
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
Brief Summary
The investigators hypothesise that a home-based standardised exercise intervention with 2g of carnosine daily for 6 months will improve walking endurance in 104 patients with PVD aged 40-80 years comp...
Detailed Description
Peripheral vascular disease (PVD) has high prevalence of 10-15% in Australia and is caused by atherosclerotic occlusion of the arteries supplying the lower extremities which reduces blood flow and lea...
Eligibility Criteria
Inclusion
- Age \>=40or \<80 years
- Clinical diagnosis Peripheral Vascular disease
- Rutherford Grade 1-3
- No significant kidney, cardiovascular, haematological, respiratory, gastrointestinal, or central nervous system disease, as well as no psychiatric disorders, no active cancer within the last five years; no presence of acute inflammation (by history, physical or laboratory examination)
- Intermittent claudication on treadmill between 30m and 200m
- Ankle Brachial index 0.6-1 at rest with minimum post exercise drop in ABI of 0.1
Exclusion
- Age \< 40 or \> 80 years
- Pregnant or lactating
- Limb threatening ischaemia- Rutherford grades 4-6, manifested by ischaemic rest pain, ulceration, or gangrene; acute limb-threatening ischaemia
- lower limb surgical or endovascular interventions in the preceding 6 months
- planned lower limb endovascular or surgical intervention within the next 6 months on either limb
- taking medication for PVD (Cilostazol and Pentoxifylline)
- inability to complete the treadmill walking test for reasons other than claudication
- myocardial infarction within last 3 months
- deep vein thrombosis within 3 months
- estimated life expectancy \< 1 year
- alcohol and illicit drug abuse.
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT03844113
Start Date
March 1 2019
End Date
December 31 2022
Last Update
December 29 2020
Active Locations (1)
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1
Monash Centre for Health Research and Implementation
Melbourne, Victoria, Australia, 3168