Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000573257p
Ethics application status
Not yet submitted
Date submitted
25/03/2018
Date registered
16/04/2018
Date last updated
16/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The use of a novel method of measuring blood flow to foot wounds in diabetic patients with aim of predicting wound healing
Scientific title
The use of Siemens Syngo Parenchymal Blood Volume (PBV) during revascularisation of diabetic patients with foot tissue loss to predict likelihood of wound healing
Secondary ID [1] 294444 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Vascular Disease 307195 0
Diabetic foot 307196 0
Condition category
Condition code
Cardiovascular 306304 306304 0 0
Diseases of the vasculature and circulation including the lymphatic system
Metabolic and Endocrine 306367 306367 0 0
Diabetes
Skin 306368 306368 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study proposes the use of a Parenchymal blood volume (PBV) software to obtain more detailed information about perfusion to the foot in diabetic patients with foot wounds. Participation will entail answering a questionnaire specific designed for the study) and undergoing lower limb angiogram in which the Siemens Syngo PBV software will be used. It is important to emphasize that all included patients would undergo angiogram regardless of the study and that the participation on the study will allow the use of Siemens PBV software as adjunct during revascularisation and to have wound photos taken prior to revascularisation and during follow-up appointments. PBV will be correlated with wound healing and non-invasive perfusion measurement techniques, namely toe pressure (TP) and transcutaneous oxygen pressure (TCPO2).
Intervention code [1] 300734 0
Diagnosis / Prognosis
Comparator / control treatment
Single arm study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305313 0
Primary outcome: Number of lower limb amputations assessed by clinical assessment during follow ups
Timepoint [1] 305313 0
12 months post-revascularisation procedure
Secondary outcome [1] 344821 0
Wound healing rate assessed by wound photos using WoundVue device during follow ups
Timepoint [1] 344821 0
up to 12 months post-revascularisation (there will be no specific follow up for the research. Patients will be seen in foot clinic as per clinical need until wound is healed where information will be collected and photo of the wound taken). Information for research purpose will be collected up to 12 months post-revascularisation. Usually these patients are seen monthly in the foot clinic, however depending on the burden of the disease - based on the size of the wound, perfusion and presence and severity of infection - they can be seen more or less frequently..

Eligibility
Key inclusion criteria
Diabetic patient with foot wound and infra-popliteal arterial disease requiring endovascular revascularisation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy or breast feeding
Estimated glomerular filtration rate (eGFR) < 45mL/min/1.73 m

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
single arm study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/06/2018
Actual
Date of last participant enrolment
Anticipated
31/01/2019
Actual
Date of last data collection
Anticipated
31/01/2020
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 10476 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 22189 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 299072 0
Hospital
Name [1] 299072 0
Royal Adelaide Hospital
Country [1] 299072 0
Australia
Primary sponsor type
Individual
Name
Guilherme Pena
Address
Vascular Surgery Department. Royal Adelaide Hospital
Port Rd, Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 298312 0
None
Name [1] 298312 0
None
Address [1] 298312 0
None
Country [1] 298312 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 300006 0
Ethics committee address [1] 300006 0
Ethics committee country [1] 300006 0
Australia
Date submitted for ethics approval [1] 300006 0
20/04/2018
Approval date [1] 300006 0
Ethics approval number [1] 300006 0

Summary
Brief summary
Participation will entail answering a questionnaire and undergoing lower limb angiogram in which the Siemens Syngo PBV software will be used. It is important to emphasize that all included patients would undergo angiogram regardless of the study and that the participation on the study will allow the use of Siemens PBV software as adjunct during revascularisation and to have wound photos taken prior to revascularisation and during follow-up appointments. Clinical management, investigations and follow-up will be conducted as per standard of care practices. There is no requirement for additional follow-ups or tests as result of participation in the research.
At recruitment Lower limb perfusion will be assessed using toe pressures and/or transcutaneous oxygen pressure and the WIfI classification system will be used to more precisely stratifying patients according to their initial disease burden. These are clinical information that are routinely obtained in the management of patients with diabetic foot ulcers. The WIfI classification was proposed in 2014 by the Society for Vascular Surgery for assessment of treatment limb which is especially applicable of patients with diabetic foot ulcer. The WIfI classification is intended to define the disease burden and allow accurate outcomes assessments and comparisons between similar groups of patients and alternative therapies. The WIfI classification system assesses three key components of a threatened limb (wound, ischemia, and foot infection), each with four grades of severity (none, mild, moderate, and severe) to predict the 1-year risk of amputation and benefit of revascularisation.
WoundVue camera will be used for more accurate and reproducible assessment of wounds. It is a hand-held portable device that takes 2D and 3D images of wounds to objectively monitor wound healing. The device algorithms are able to interpret tissue types and automatically provide surface, volume and depth measurement.
All participants will undergo an endovascular revascularisation procedure which will be performed by a Vascular Surgeon (Prof Robert Fitridge, Dr Ewan Macaulay, Dr Joseph Dawson, Dr Michael Herbert or Dr Kurian Mylankal) with vast experience in this procedure. The revascularisation aims to restore perfusion to the affected foot and subsequently promote wound healing, help to resolve infection and avoid or limit level of amputation. PBV which indicates the distribution of blood in lesions and surrounding tissue by means of color-coded cross-sectional blood volume maps will be assessed before and after angioplasty/stenting.
Data on foot wound status, treatments administered and outcomes (wound healing or amputation) will be collected during follow up visits over 12 months. WoundVue camera will used for more accurate, frequent and reproducible assessment of wound healing. Details of data to be collected are giving in baseline data and follow up data forms
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82242 0
Prof Robert Fitridge
Address 82242 0
Royal Adelaide Hospital, Department of Vascular Surgery
Port Road, Adelaide SA 5000
Country 82242 0
Australia
Phone 82242 0
+61 08 7074 2510
Fax 82242 0
Email 82242 0
[email protected]
Contact person for public queries
Name 82243 0
Guilherme Pena
Address 82243 0
Department of Vascular Surgery, Royal Adelaide Hospital
Port Rd, Adelaide SA 5000
Country 82243 0
Australia
Phone 82243 0
+61 08 7074 2510
Fax 82243 0
Email 82243 0
[email protected]
Contact person for scientific queries
Name 82244 0
Guilherme Pena
Address 82244 0
Department of Vascular Surgery, Royal Adelaide Hospital
Port Rd, Adelaide SA 5000
Country 82244 0
Australia
Phone 82244 0
+61 08 7074 2510
Fax 82244 0
Email 82244 0
[email protected]

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.