Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Scientific title
A phase 1 safety trial of CANN001, a hydrogel patch containing 2-deoxy-D-Ribose, in diabetic foot ulcers
Secondary ID [1] 312746 0
ROWING BOAT trial
Universal Trial Number (UTN)
Trial acronym
ROWING BOAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
diabetic foot ulcer 334778 0
Condition category
Condition code
Skin 331340 331340 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 329275 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339122 0
Treatment emergent adverse events
Assessment method [1] 339122 0
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
Timepoint [1] 339122 0
Baseline, at each dose and at 1, 3 and 6 months after initiation of the intervention
Primary outcome [2] 339123 0
Incidence of clinically significant changes from baseline in haematology and immunopathology Hematology/Immunopathology: full blood count
Assessment method [2] 339123 0
Clinical laboratory blood samples, assessed for changes outside the normal range
Timepoint [2] 339123 0
baseline, 1 week and 6 months after initiation of the intervention
Primary outcome [3] 339693 0
Clinically significant changes in Kidney function assessed using serum creatinine, blood urea nitrogen, estimated glomerular filtration rate as a composite measure of kidney function.
Assessment method [3] 339693 0
Clinical laboratory blood samples, assessed for changes outside the normal range
Timepoint [3] 339693 0
baseline, 1 week and 6 months after initiation of the intervention
Secondary outcome [1] 438623 0
Levels of VEGF in wound fluid samples
Assessment method [1] 438623 0
Enzyme Linked Immunosorbent Assay
Timepoint [1] 438623 0
baseline, end of treatment
Secondary outcome [2] 440912 0
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.
Assessment method [2] 440912 0
Clinical laboratory blood samples, assessed for changes outside the normal range
Timepoint [2] 440912 0
baseline, 1 week and 6 months after initiation of the intervention

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/11/2024
Actual
Date of last participant enrolment
Anticipated
30/04/2025
Actual
Date of last data collection
Anticipated
30/10/2025
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 317177 0
Commercial sector/Industry
Name [1] 317177 0
Cannenta
Country [1] 317177 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Country
Australia
Secondary sponsor category [1] 319482 0
None
Name [1] 319482 0
Country [1] 319482 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315921 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 315921 0
Ethics committee country [1] 315921 0
Australia
Date submitted for ethics approval [1] 315921 0
01/02/2024
Approval date [1] 315921 0
23/05/2024
Ethics approval number [1] 315921 0
RGS0000006774

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 136222 0
Prof Laurens Manning
Address 136222 0
Fiona Stanley Hospital 11 Robin Warren Drive, Murdoch, WA 6150
Country 136222 0
Australia
Phone 136222 0
+61 480 370 824
Email 136222 0
laurens.manning@health.wa.gov.au
Contact person for public queries
Name 136223 0
mark fear
Address 136223 0
University of Western Australia, 6 Verdun street, Nedlands, WA 6009
Country 136223 0
Australia
Phone 136223 0
+61 411355944
Email 136223 0
mark.fear@uwa.edu.au
Contact person for scientific queries
Name 136224 0
mark fear
Address 136224 0
University of Western Australia, 6 Verdun street, Nedlands, WA 6009
Country 136224 0
Australia
Phone 136224 0
+61 411355944
Email 136224 0
mark.fear@uwa.edu.au

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Data will be accessible to all

Conditions for requesting access:
• -

What individual participant data might be shared?
• All individual participant data related to the trial after deidentification (no identifying parameters will be shared)

What types of analyses could be done with individual participant data?
• Any purpose

When can requests for individual participant data be made (start and end dates)?
From:
Immediately on publication of the trial and with no end date

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Data will be shared through publication and/or accessible repository. Person to be contacted is Mark Fear, mark.fear@uwa.edu.au

Are there extra considerations when requesting access to individual participant data?
No


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.