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Trial registered on ANZCTR
Registration number
ACTRN12624001290583
Ethics application status
Approved
Date submitted
6/10/2024
Date registered
23/10/2024
Date last updated
23/10/2024
Date data sharing statement initially provided
23/10/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
A phase 1 safety trial of CANN001, a hydrogel patch containing 2-deoxy-D-Ribose, in diabetic foot ulcers
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Scientific title
A phase 1 safety trial of CANN001, a hydrogel patch containing 2-deoxy-D-Ribose, in diabetic foot ulcers
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Secondary ID [1]
312746
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ROWING BOAT trial
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Universal Trial Number (UTN)
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Trial acronym
ROWING BOAT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
diabetic foot ulcer
334778
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Condition category
Condition code
Skin
331340
331340
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0
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Trial participants will receive between 3-7 treatments with CANN001, a hydrogel dressing containing 0.3% 2deoxy-D-ribose. Each patient will receive 3-7 dressings with a dressing change every 48 hours (ascending dose of 3, 5 and finally 7 dressings applied with 6 participants in each group (1:1:1 for 3:5:7 dressings respectively). Dressings will be applied in clinic by a podiatrist on each occasion.
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Intervention code [1]
329275
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Treatment: Devices
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Treatment emergent adverse events
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Assessment method [1]
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Each AE and SAE reported during the study will be assessed for intensity using the CTCAE V5.0 criteria. The assessments will be based on the Investigator’s clinical judgment. Possible adverse events may be site reactions (such as erythema around ulcer site) or infection of the DFU
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Timepoint [1]
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Baseline, at each dose and at 1, 3 and 6 months after initiation of the intervention
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Primary outcome [2]
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Incidence of clinically significant changes from baseline in haematology and immunopathology
Hematology/Immunopathology: full blood count
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Assessment method [2]
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Clinical laboratory blood samples, assessed for changes outside the normal range
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Timepoint [2]
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baseline, 1 week and 6 months after initiation of the intervention
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Primary outcome [3]
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Clinically significant changes in Kidney function assessed using serum creatinine, blood urea nitrogen, estimated glomerular filtration rate as a composite measure of kidney function.
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Assessment method [3]
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Clinical laboratory blood samples, assessed for changes outside the normal range
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Timepoint [3]
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baseline, 1 week and 6 months after initiation of the intervention
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Secondary outcome [1]
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Levels of VEGF in wound fluid samples
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Assessment method [1]
438623
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Enzyme Linked Immunosorbent Assay
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Timepoint [1]
438623
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baseline, end of treatment
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Secondary outcome [2]
440912
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Liver function: total & direct bilirubin, albumin, total protein, alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase and alkaline phosphatase as a composite measure of liver function. This is another primary outcome measure.
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Assessment method [2]
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Clinical laboratory blood samples, assessed for changes outside the normal range
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Timepoint [2]
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baseline, 1 week and 6 months after initiation of the intervention
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Eligibility
Key inclusion criteria
• Aged 18 years and over
• Confirmed diagnosis of Diabetes (type 1 or 2) defined according to international consensus guidelines
• Patients with diabetic foot ulcer (below the level of the medial and lateral malleoli) that has been present for a minimum of 4 weeks.
• WIFI grade 1 classification wound
• No clinically active wound infection
• Ankle brachial index > 0.4
• Toe pressure > 50mM Hg or Transcutaneous oxygen measurement >40mmHg
• Ulcer area of minimum 1cm2 to a maximum of 10cm in both directions (100cm2)
• The ulcer location, contour, shape and wound base is deemed to be suitable for patch application
• No further debridement or amputation is anticipated
• Wound bed is adequately vascularised as determined by the presence of at least one palpable pulse in the affected foot or at least single vessel run off visualised by arterial doppler ultrasonography, MRI, CT or conventional angiography (including revascularisation procedures)
• Participant is willing to not become pregnant and use contraception as required for duration of the trial either for themselves and/or partner
• Competent and willing to provide consent
• Has not participated in another research trial within 3 months of enrolment
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
• Any pathology that, based on the judgement of the researcher, could alter the course of DFU (neoplasia, immunological disorders)
• Wounds deemed unsuitable on the basis of contour, location vascularity or other factors
• Wounds with large amount (high) drainage
• Infected ulcer
• Fever
• Limb threatening ischemia or sepsis requiring early major amputation
• Unlikely to be accessible for follow-up visit over the next 6 months
• Major acute or chronic medical illnesses that could affect wound healing (e.g. peripheral vascular disease, blood clotting disorder)
• Patient receiving treatment with medication that inhibit or compromise wound healing e.g. therapeutic anticoagulants, antiplatelet drugs and systemic steroids such as warfarin, clopidogrel or prednisone. The use of anticoagulants does not include DVT prophylaxis, Patients may use aspirin
• History of AIDS
• Serum GGT, AST or ALT > 5 × upper limit of the normal range (ULN).
• History of organ transplant or impending transplant
• Renal insufficiency requiring dialysis
• Distal necrosis of the limb with the ulcer
• Clinical findings suggesting complicated venous insufficiency of 1L
• Lymphedema
• Oral steroid use in last 3 months
• Active malignancy (cancer)
• Pregnant women
• Breast feeding mothers
• Late presentations over 1 week
• Current substance or alcohol abuse
• Acute osteomyelitis or bone infection of the affected foot, where subject has received less than 4 weeks of systemic antibiotics at the time of Screening and less than 6 weeks prior to Randomization (systemic antibiotic regimen must be completed at the time of Randomization).
• Subjects with suspected infection who have received less than 2 weeks of systemic antibiotics, or have not had surgical resection of clinically diagnosed osteomyelitis
• Known allergy/hypersensitivity to any of the components of the investigation products
Unable to keep research appointments
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
Safety
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
11/11/2024
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Actual
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Date of last participant enrolment
Anticipated
30/04/2025
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Actual
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Date of last data collection
Anticipated
30/10/2025
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Actual
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Sample size
Target
18
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Cannenta
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Address [1]
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Country [1]
317177
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Australia
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Primary sponsor type
University
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Name
University of Western Australia
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Address
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Country
Australia
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Secondary sponsor category [1]
319482
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None
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Name [1]
319482
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Address [1]
319482
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Country [1]
319482
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315921
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South Metropolitan Health Service Human Research Ethics Committee
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Ethics committee address [1]
315921
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https://smhs.health.wa.gov.au/Our-research/For-researchers
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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01/02/2024
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Approval date [1]
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23/05/2024
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Ethics approval number [1]
315921
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RGS0000006774
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Summary
Brief summary
Diabetic foot ulcers are a chronic wound and the pathophysiology is linked to neuropathy, infection and peripheral vascular disease. This peripheral vascular disease, linked to diabetes, prevents ulcer closure and leads to susceptibility to infection. 2-deoxy-D-ribose (2dDr) is known to promote vascularisation and may therefore increase angiogenesis when administered to a DFU and through this mechanism promote wound closure. The planned study will investigate if CANN001 (2dDr containing hydrogel) is safe in patients with diabetic foot ulcers and whether 2dDr may promote DFU healing and localised wound angiogenesis/neovascularisation through increasing local expression of VEGF.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Laurens Manning
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Address
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Fiona Stanley Hospital 11 Robin Warren Drive, Murdoch, WA 6150
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Country
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Australia
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Phone
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+61 480 370 824
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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mark fear
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Address
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University of Western Australia, 6 Verdun street, Nedlands, WA 6009
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Country
136223
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Australia
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Phone
136223
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+61 411355944
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Fax
136223
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Email
136223
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[email protected]
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Contact person for scientific queries
Name
136224
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mark fear
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Address
136224
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University of Western Australia, 6 Verdun street, Nedlands, WA 6009
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Country
136224
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Australia
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Phone
136224
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+61 411355944
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Fax
136224
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Email
136224
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
All individual participant data related to the trial after deidentification (no identifying parameters will be shared)
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When will data be available (start and end dates)?
Immediately on publication of the trial and with no end date
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Available to whom?
Data will be accessible to all
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Available for what types of analyses?
Any purpose
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How or where can data be obtained?
Data will be shared through publication and/or accessible repository. Person to be contacted is Mark Fear,
[email protected]
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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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