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Trial registered on ANZCTR


Registration number
ACTRN12618000608268p
Ethics application status
Not yet submitted
Date submitted
13/04/2018
Date registered
19/04/2018
Date last updated
19/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of a novel synthetic for treatment of deep foot wounds in diabetic patients
Scientific title
Use of a biodegradable polyurethane matrix in the reconstruction of diabetic foot wounds: a pilot study.
Secondary ID [1] 294595 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic foot wound 307399 0
Condition category
Condition code
Metabolic and Endocrine 306507 306507 0 0
Diabetes
Skin 306508 306508 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Application of biodegradable temporising matrix (BTM) to complex diabetic foot wounds (defined by exposure of deep structures such as tendon, bone and joint). This may be followed by skin grafting approximately 4 weeks later.
It is a single application in theatre which will be performed by a Plastic Surgeon. Following this intervention the wound will needed to be dressed 2 times a week for approximately 4 weeks. Dressing changes will be performed by a nurse specialist in wound under supervision of plastic surgeon.
Wounds larger than 4sq cm will be considered for skin grafting approximately 4 weeks post BTM application. Skin grafting will be performed in theatre by a plastic or vascular surgeon with experience in this procedure.
Intervention code [1] 300891 0
Treatment: Surgery
Intervention code [2] 300892 0
Treatment: Devices
Comparator / control treatment
Single arm study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305510 0
Proportion of patients with wound healed assessed by clinical assessment and wound photography during follow up.
Complete healing defined as complete epithelialization of the wound.
Timepoint [1] 305510 0
12 weeks post BTM application
Secondary outcome [1] 345548 0
Wound healing rate assessed by wound photography
Timepoint [1] 345548 0
At 4, 8 and 12 weeks post BTM application
Secondary outcome [2] 345549 0
Time for complete wound healing assessed by clinical assessment and wound photography during follow ups.
Timepoint [2] 345549 0
up to 12 months post BTM application
After integration of the BTM 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-BTM application. 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
1. Age greater than 18 years
2. Diagnosis of diabetes, as determined by HbA1c greater than 6.5% or currently on diabetic medication
3. HBA1c less than 12% taken prior to enrolment
4. Foot wound larger than 1cm2
5. Complex deep wounds with exposed tendon, muscle, fascia, joint or bone, for which direct skin grafting may not be recommended.
6. Acceptable circulation to the affected extremity, as demonstrated by one of the following within the past 60 days: a) Transcutaneous oxygen pressure (TcPO2) around the wound greater than 25mmHg, b) Toe pressure greater than 30mmHg, c) Doppler arterial waveforms biphasic or triphasic in at least one artery at the ankle level
7. Have read and agreed to participate voluntarily and signed an informed consent form
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Active infection – as defined by presence of at least 2 of the following items: local swelling or induration / erythema > 0.5cm around the wound / local tenderness or pain / local warmth / purulent discharge
2. Patients currently receiving radiation therapy or chemotherapy
3. Patient with uncontrolled autoimmune connective disease
4. Evidence of osteomyelitis on imaging tests (x-ray; bone scan; MRI)
5. Patients who are pregnant of breast feeding
6. Patients unable to be followed-up in the Adelaide metropolitan area

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 10679 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 10680 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 22399 0
5000 - Adelaide
Recruitment postcode(s) [2] 22400 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 299212 0
Hospital
Name [1] 299212 0
Royal Adelaide Hospital
Address [1] 299212 0
Port Rd, Adelaide SA 5000
Country [1] 299212 0
Australia
Primary sponsor type
Individual
Name
Dr Joseph Dawson
Address
Department of Vascular Surgery
Royal Adelaide Hospital
Port rd. Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 298477 0
None
Name [1] 298477 0
Address [1] 298477 0
Country [1] 298477 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 300132 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 300132 0
The Queen Elizabeth Hospital
Ethics: DX465101
Ground Floor, Basil Hetzel Institute
28 Woodville Road
WOODVILLE SOUTH SA 5011
Ethics committee country [1] 300132 0
Australia
Date submitted for ethics approval [1] 300132 0
25/04/2018
Approval date [1] 300132 0
Ethics approval number [1] 300132 0

Summary
Brief summary
Complex diabetic foot wounds such as those with exposed tendon, muscle, fascia, joint or bone, present a great therapeutic challenge to health care professionals. This research aims to assess the use of a biodegradable temporising matrix (BTM) in reconstruction of complex diabetic foot wounds.
BTM is entirely synthetic matrix made of polyurethane and works as a scaffold that results in creation of new dermis-like layer. It has the potential to improve wound healing complex wounds as it has been demonstrated in previous human studies.
Participants will be diabetic patients with deep complex foot. Intervention will consist of of application of BTM in theatre followed by split skin grafting at a later date if necessary. Wound healing will be assessed using a WoundVue camera, which is a hand held portable device that takes 2D and 3D images and provides wound measurements.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82670 0
Mr Joseph Dawson
Address 82670 0
Department of Vascular Surgery
Level 7 - Royal Adelaide Hospital
Port Rd. Adelaide. SA 5000
Country 82670 0
Australia
Phone 82670 0
+61 8 7074 1825
Fax 82670 0
Email 82670 0
joedawso@gmail.com
Contact person for public queries
Name 82671 0
Mr Joseph Dawson
Address 82671 0
Department of Vascular Surgery
Level 7 - Royal Adelaide Hospital
Port Rd. Adelaide. SA 5000
Country 82671 0
Australia
Phone 82671 0
+61 8 7074 1825
Fax 82671 0
Email 82671 0
joedawso@gmail.com
Contact person for scientific queries
Name 82672 0
Mr Joseph Dawson
Address 82672 0
Department of Vascular Surgery
Level 7 - Royal Adelaide Hospital
Port Rd. Adelaide. SA 5000
Country 82672 0
Australia
Phone 82672 0
+61 8 7074 1825
Fax 82672 0
Email 82672 0
joedawso@gmail.com

No data has been provided for results reporting
Summary results
Not applicable