None listed
Conditions
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.
Interventions
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.
Sponsors
University of Western Australia
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed