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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Carnosine for Peripheral Vascular Disease
Scientific title
Carnosine for Peripheral Vascular Disease
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Arterial Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Study type
Description of intervention(s) / exposure
Treatment: Drugs - Carnosine
Treatment: Drugs - Placebo

Active Comparator: Intervention - Each participant will be given a daily oral dose 2 g of carnosine for 6 months

Placebo Comparator: Control - Each participant will be given a daily oral dose 2 g of placebo for 6 months

Treatment: Drugs: Carnosine
Each participant will be given a daily oral dose 2 g of carnosine for 6 months

Treatment: Drugs: Placebo
Each participant will be given a daily oral dose 2 g of methycellulose powder for 6 months

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Primary outcome [1] 0 0
walking endurance - change in walking endurance (6-min walk test)
Timepoint [1] 0 0
6 months

Key inclusion criteria
- 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
Minimum age
40 Years
Maximum age
80 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- 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.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Monash Centre for Health Research and Implementation - Melbourne
Recruitment postcode(s) [1] 0 0
3168 - Melbourne

Funding & Sponsors
Primary sponsor type
Monash University
Other collaborator category [1] 0 0
Name [1] 0 0
Monash Health
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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 compared to placebo and exercise through stabilisation of HIF1-a in the ischaemic


Aim 1: Determine whether in patients with PVD, carnosine in addition to exercise improves:

1. walking endurance (6-min walk test; primary outcome);

2. initial claudication distance (ICD), and absolute claudication distance (ACD;
treadmill), cadence, resting and exercise ABI; and

3. central blood pressure, endothelial function, arterial (aortic) stiffness, lipid
profile; and

4. quality of life as determined by EuroQol-5D (all secondary outcomes).

5. Improve cognitive function (global cognitive score formed by a composite of 7 cognitive

Aim 2: Delineate the mechanisms by which carnosine improves walking endurance:

1. protein expression of pro-angiogenic and carnosine related genes, including carnosine
transporters in the skeletal muscle biopsies, EPCs in peripheral blood and quantitative
proteomic studies.

2. other mechanisms demonstrated in animal studies including plasma inflammatory markers,
serum and urinary advanced glycation (AGE) and lipoxidation (ALE) end-products (tertiary

This trial will provide evidence for use of carnosine as a therapeutic intervention for PVD
patients and, if positive, will have immediate clinical application.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Barbora deCourten, MD,PHD,MPH
Address 0 0
Monash University and Monash Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Barbora deCourten, MD,PHD,MPH
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see