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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Peripheral Vascular Disease

Diabetic foot

Condition category

Condition code

Cardiovascular

Diseases of the vasculature and circulation including the lymphatic system

Metabolic and Endocrine

Diabetes

Skin

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]

Diagnosis / Prognosis

Comparator / control treatment

Single arm study

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Primary outcome: Number of lower limb amputations assessed by clinical assessment during follow ups

Timepoint [1]

12 months post-revascularisation procedure

Secondary outcome [1]

Wound healing rate assessed by wound photos using WoundVue device during follow ups

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

The Royal Adelaide Hospital - Adelaide

Recruitment postcode(s) [1]

5000 - Adelaide

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Royal Adelaide Hospital

Address [1]

Royal Adelaide Hospital
Port Rd, Adelaide SA 5000

Country [1]

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]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

20/04/2018

Approval date [1]

Ethics approval number [1]

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

Prof Robert Fitridge

Address

Royal Adelaide Hospital, Department of Vascular Surgery
Port Road, Adelaide SA 5000

Country

Australia

Phone

+61 08 7074 2510

Fax

[email protected]

Contact person for public queries

Name

Guilherme Pena

Address

Department of Vascular Surgery, Royal Adelaide Hospital
Port Rd, Adelaide SA 5000

Country

Australia

Phone

+61 08 7074 2510

Fax

[email protected]

Contact person for scientific queries

Name

Guilherme Pena

Address

Department of Vascular Surgery, Royal Adelaide Hospital
Port Rd, Adelaide SA 5000

Country

Australia

Phone

+61 08 7074 2510

Fax

[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.

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