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Trial registered on ANZCTR


Registration number
ACTRN12622000360718
Ethics application status
Approved
Date submitted
21/02/2022
Date registered
1/03/2022
Date last updated
1/03/2022
Date data sharing statement initially provided
1/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Nutrition supplementation before and after revascularisation procedure for people with peripheral arterial disease compared to usual care
Scientific title
The effect of nutrition supplementation before and after revascularisation procedure in people with peripheral arterial disease compare to usual care: The Peri-operative nutrition in Peripheral Arterial Disease (PPAD) trial.
Secondary ID [1] 303880 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PPAD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral arterial disease 321456 0
Revascularisation procedure 325404 0
Condition category
Condition code
Cardiovascular 319218 319218 0 0
Other cardiovascular diseases
Diet and Nutrition 319219 319219 0 0
Other diet and nutrition disorders
Surgery 322792 322792 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
- Ensure Plus Strength, a pre-packaged oral liquid supplement will be administered for 6 weeks.
- Dosage will be individualised based on food frequency questionnaire and assessment of dietary intake of immune-modulating nutrients, in particular vitamins and minerals by an Accredited Practising Dietitian. The target is to achieve the Recommended Daily Intake (RDI) or Adequate Intake (AI) as per the Australian and New Zealand Nutrient Reference Values (NRVs). The dosage will be 1 or 2 x 220ml bottles of the supplement each day.
- Adherence to the intervention will be monitored using a participant diary to record the prescribed amount of supplement and the amount actually consumed. The diary will also be used to monitor for any side effects.
Intervention code [1] 320185 0
Treatment: Other
Comparator / control treatment
Participants in the control group will receive usual care. The usual care process is for patients who are recognised by the treating surgeon (in outpatients) or the treating surgical team/ward staff (inpatients) to refer the patient to the clinical dietetic service.
Control group
Active

Outcomes
Primary outcome [1] 327089 0
Binary restenosis (restenosis >50%) as determined by duplex ultrasound.
Timepoint [1] 327089 0
Day 1 post-procedure, 1, 3, 6 and 12 months (primary endpoint) post revascularisation procedure.
Secondary outcome [1] 393751 0
Target lesion revascularisation recorded from medical records
Timepoint [1] 393751 0
12-months post procedure
Secondary outcome [2] 393752 0
Serum markers of inflammation/oxidative stress including hydrogen peroxide, haemoxygenase, NADPH Oxidases, IL-2, TNF-alpha and IFN-ywill be assayed using ELISA techniques.
Timepoint [2] 393752 0
baseline and 1 month post-procedure
Secondary outcome [3] 402645 0
Quality of life will be measured using the AusVIQOL (validated QoL tool for patients with PAD)
Timepoint [3] 402645 0
Baseline, 1 month, 3months, 6 months and 12 months post-procedure
Secondary outcome [4] 406762 0
Primary/primary assisted/secondary patency recorded prospectively at follow-up from medical records
Timepoint [4] 406762 0
1,3,6 and 12 months post procedure
Secondary outcome [5] 406764 0
Length of stay of the index admission from medical records
Timepoint [5] 406764 0
on discharge
Secondary outcome [6] 406765 0
Systemic Complications (include, but not limited to, myocardial infarction, new arrhythmia, stroke, renal failure, pneumonia, urinary tract infection) collected from medical records
Timepoint [6] 406765 0
on discharge from index admission and 30-day post procedure (primary endpoint)
Secondary outcome [7] 406766 0
Wound complications (include wound infection, dehiscnece, seroma and lymph leak) collected from medical records
Timepoint [7] 406766 0
on discharge from index admission and 30-days post procedure (primary endpoint)
Secondary outcome [8] 406767 0
Wound/Ulcer healing determined using digital photography and wound tracing (location, size and surface area).
Timepoint [8] 406767 0
baseline, 1,3,6 and 12 month post-procedure or until complete epithelialisation if occurs prior to 12-months.
Secondary outcome [9] 406768 0
Mortality (all cause) from the Australian death registry
Timepoint [9] 406768 0
12-months post procedure
Secondary outcome [10] 406769 0
Amputation-free survival collected from hospital records and the Australian death registry
Timepoint [10] 406769 0
12 months post procedure
Secondary outcome [11] 406770 0
all-cause hospital re-admissions will be collected from hospital records
Timepoint [11] 406770 0
12-months post procedure
Secondary outcome [12] 406979 0
QoL will be measured using the EQ-5D-5L questionnaire (questionnaire suitable for economic analysis)
Timepoint [12] 406979 0
baseline, 1,3,6 and 12 months post-procedure
Secondary outcome [13] 406980 0
disease-related hospital admissions collected from hospital records
Timepoint [13] 406980 0
12 months post procedure

Eligibility
Key inclusion criteria
Inpatients and outpatients at Flinders Medical Centre who are scheduled to undergo open or endovascular revascularisation for PAD.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they are: 1) <18 years old; 2) have been diagnosed with a terminal illness; 3) are unable to communicate effectively to provide informed consent such as those with cognitive impairment; 4) have a diagnosis of galactosemia (a contra-indication to immuno-nutrition supplement) or 5) have a fluid restriction.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes created and administered by staff not involved in the research.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation created by staff not involved in the research. Randomisation will be stratified by inpatient and outpatient and also those by diabetes and non-diabetes.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Randomisation occurs after baseline appointment.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Phase one of the trial will consist of 76 patients (38/group). This will then allow for interim analysis to inform the sample size required to complete the trial (phase two). Patient data from phase one will be rolled over into phase two of the trial. Our expectation at this stage, based on previous work on vascular restenosis, is that we expect to see a 50% 12 month reduction in restenosis rates using perioperative nutrition. Therefore, with an alpha value of 0.05 and beta value of 0.2, we will require 120 patients per group to be adequately powered. Assuming a 10% drop-out, we will recruit 132 patients per group (264 total).

Primary analysis will be undertaken using ITT principles. Independent sample t-tests or Mann-Whitney U tests and related sample student t-tests or Wilcoxon-sign tests across and within the two groups will be undertaken, as appropriate. Statistical significance will be set at p=0.05

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/03/2022
Actual
Date of last participant enrolment
Anticipated
31/03/2023
Actual
Date of last data collection
Anticipated
29/03/2024
Actual
Sample size
Target
264
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 19060 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 33610 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 308273 0
Commercial sector/Industry
Name [1] 308273 0
Abbott Medical Australia Pty Ltd
Country [1] 308273 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Abbott Medical Australia Pty Ltd
Address
299 Lane Cove Rd, Macquarie Park NSW 2113
Country
Australia
Secondary sponsor category [1] 309070 0
None
Name [1] 309070 0
Address [1] 309070 0
Country [1] 309070 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308249 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 308249 0
Level 6, Flinders Medical Centre, Bedford Park SA 5042
Ethics committee country [1] 308249 0
Australia
Date submitted for ethics approval [1] 308249 0
12/04/2021
Approval date [1] 308249 0
28/01/2022
Ethics approval number [1] 308249 0

Summary
Brief summary
The study is a randomised controlled trial investigating the effect of 6 weeks of immuno-nutrition supplementation on post-procedure vascular complications and hospital length of stay in patients with peripheral arterial disease scheduled for revascularisation procedure. It is hypothesized that supplementation with an immuno-nutrient containing supplement will lead to improved clinical outcomes in patients with peripheral arterial disease through the attenuation of the inflammatory process component of atherosclerosis.
Intervention participants will receive individualised supplementation for 2 weeks prior to the revascularisation procedure and 4-weeks post -procedure under the direction of an Accredited Practicing Dietitian. Control participants will receive usual clinical care where no immune-nutrition supplementation is provided. All participants will be followed up at 1-, 3-, 6- and 12-months post-procedure as apart of usual clinical care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110070 0
A/Prof Christopher Delaney
Address 110070 0
Department Vascular and Endovascular Surgery, Flinders Medical Centre, Flinders Dr, Bedford Park SA 5042
Country 110070 0
Australia
Phone 110070 0
+61 8 8204 5445
Fax 110070 0
Email 110070 0
chris.delaney@sa.gov.au
Contact person for public queries
Name 110071 0
A/Prof Christopher Delaney
Address 110071 0
Department Vascular and Endovascular Surgery, Flinders Medical Centre, Flinders Dr, Bedford Park SA 5042
Country 110071 0
Australia
Phone 110071 0
+61 8 8204 5445
Fax 110071 0
Email 110071 0
chris.delaney@sa.gov.au
Contact person for scientific queries
Name 110072 0
A/Prof Christopher Delaney
Address 110072 0
Department Vascular and Endovascular Surgery, Flinders Medical Centre, Flinders Dr, Bedford Park SA 5042
Country 110072 0
Australia
Phone 110072 0
+61 8 8204 5445
Fax 110072 0
Email 110072 0
chris.delaney@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics approval and consent for this was not sort for the purposes of this trial.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.