Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000384550
Ethics application status
Approved
Date submitted
29/08/2006
Date registered
31/08/2006
Date last updated
23/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The VAC Trial
Scientific title
Randomised Controlled trial of the efficacy and cost-effectiveness of the Vacuum-assisted closure therapy (VAC) system as an alternative to standard arterial ulcer management in a hospital-at-home setting.
Secondary ID [1] 295887 0
Nil known
Universal Trial Number (UTN)
Trial acronym
VAC TRIAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with chronic foot wound which have not healed 1350 0
Condition category
Condition code
Other 1440 1440 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with foot wound of a volume between 10-100ml or surface area between 5 – 100cm2 that have not healed for a minimum of one month and meet all set criteria (inclusion/exclusion) are invited to participate in the study. Patients are randomised to receive VAC Therapy (KCI) for a period of 6 weeks. The frequency of the VAC Therapy is for a period of 6 weeks with the device to be on for 22 hours out of 24 hours in a day everyday for the length of the study. If the wound has not healed after 6 weeks with VAC Therapy, patients are to receive standard wound therapy.
Intervention code [1] 1334 0
Treatment: Devices
Comparator / control treatment
Receive standard wound therapy for a period of 6 weeks.
Control group
Active

Outcomes
Primary outcome [1] 1978 0
To determine the efficacy of the VAC system compared to standard arterial ulcer management in a hospital-at-home setting.
Timepoint [1] 1978 0
Assessed weekly at an outpatient clinic by a study nurse or doctor. Patients are assessed each week for 6 weeks and are sent a patient satisfaction question once they have completed the trial.
Primary outcome [2] 1979 0
To determine the cost-effectiveness of the VAC system compared to standard arterial ulcer management in a hospital-at-home setting.
Timepoint [2] 1979 0
Assessed weekly at an outpatient clinic by a study nurse or doctor. Patients are assessed each week for 6 weeks and are sent a patient satisfaction question once they have completed the trial.
Secondary outcome [1] 3446 0
Wound volumes and wound surface area
Timepoint [1] 3446 0
Examined at each visit to determine how well the wound is healing.
Secondary outcome [2] 3447 0
Quality of Life Questionnaires
Timepoint [2] 3447 0
Given at Visit 1, 3 and 7
Secondary outcome [3] 3448 0
Patient Satisfaction Questionnaire
Timepoint [3] 3448 0
At Visit 7 to determine patient's happiness with their therapy.

Eligibility
Key inclusion criteria
Patients are eligible to be included in the study only if they meet all of the following criteria:1.Provide signed informed consent. 2.Have foot wounds. 3.Have or preoperatively had toe pressures >30mmHg or palpable toe pressures. 4.Have wounds that have not healed in 1 month. 5.Wound volume is between 10 –100 ml or surface area is between 5 –100 cm2 , after debridement 6.Wounds are suitable to be managed at home. 7.Patients with a diabetic foot ulcer, with toe pressures greater than 30mmHg or palpable toe pressures.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Have malignancy in the wound2.Untreated osteomyelitis3.Non-enteric and unexplored fistula4.Necrotic tissue with eschar present5.Active bleeding6.Difficult wound hemostasis7.Patient is on anticoagulants8.Wound has exposed blood vessels or organs9.Patients have irradiated, weakened or sutured blood vessels10.Patient has within the last 30 days / is undergoing hyperbaric oxygen therapy11.Patients have allergies to adhesive drape12.Patients are to have surgical interventionsFor statistical purposes, both males and females are included in this study.

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)
Central randomisation by a computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer database created in access to determine what treatment each patient is given. Database designer not involved in study process
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
21/07/2004
Actual
8/06/2004
Date of last participant enrolment
Anticipated
Actual
4/08/2005
Date of last data collection
Anticipated
Actual
8/09/2005
Sample size
Target
40
Accrual to date
Final
9
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1579 0
Commercial sector/Industry
Name [1] 1579 0
KCI Medical Australia
Country [1] 1579 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
KCI Medical Australia
Address
Country
Australia
Secondary sponsor category [1] 1386 0
Hospital
Name [1] 1386 0
Department of Surgery, The Queen Elizabeth Hospital
Address [1] 1386 0
Country [1] 1386 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3004 0
The Queen Elizabeth Hospital Central Northern Adelaide Health Service Ethics Committee
Ethics committee address [1] 3004 0
Ethics committee country [1] 3004 0
Australia
Date submitted for ethics approval [1] 3004 0
Approval date [1] 3004 0
26/02/2004
Ethics approval number [1] 3004 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27941 0
Address 27941 0
Country 27941 0
Phone 27941 0
Fax 27941 0
Email 27941 0
Contact person for public queries
Name 10523 0
Catherine Easterbrook
Address 10523 0
Department of Surgery
The Queen Elizabeth Hospital
Level 6A
28 Woodville Road
Woodville South SA 5011
Country 10523 0
Australia
Phone 10523 0
+61 8 82226852
Fax 10523 0
+61 8 82226028
Email 10523 0
catherine.easterbrook@adelaide.edu.au
Contact person for scientific queries
Name 1451 0
Professor Guy Maddern
Address 1451 0
Department of Surgery
The Queen Elizabeth Hospital
Level 6A
28 Woodville Road
Woodville South SA 5011
Country 1451 0
Australia
Phone 1451 0
+61 8 82226750
Fax 1451 0
+61 8 82226028
Email 1451 0
guy.maddern@adelaide.edu.au

No information has been provided regarding IPD availability


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.