This is a prospective, multicentre, randomized clinical trial evaluating the safety, tolerability, and efficacy of up to 12 weeks treatment with SoC + low- or high-dose CYWC628 in treating DFU, compared to SoC only.
Males or females aged 18 to 80 years inclusive at time of informed consent.
Diagnosed/confirmed Type 1 or 2 diabetes mellitus.
Presence of diabetic foot ulcer (DFU) at or below the level of the malleolus that is confined to one anatomical site and without exposure of bone and/or joint capsule.
DFU Wagner Grade 1 or 2.
The DFU had been previously treated, or is being treated, with growth factors, stem cells, or any equivalent preparation within 8 weeks before Screening.
Enrolment in another interventional clinical foot ulcer healing trial within 4 weeks before Screening, or participation in any other interventional research study within 8 weeks before screening.
Additional wound(s) within 3 cm of the study target wound.
History of conditions that may impair wound healing in the opinion of the Investigator, for example, autoimmune disorders, renal failure patients on dialysis, or medications that impair the healing process. .
Parallel
Standard of Care (SOC)
Other interventionThe participant's DFU will be sharply debrided (as needed), dressed with SoC and offloaded.
SoC + Low dose CYWC628
Biological/VaccineThe participant's DFU will be sharply debrided (as needed), dressed with SoC and offloaded. Low dose CYWC628 applied once weekly to diabetic foot ulcer (DFU) for up to 12 weeks
SoC + High dose CYWC628
Biological/VaccineThe participant's DFU will be sharply debrided (as needed), dressed with SoC and offloaded. High dose CYWC628 applied once weekly to diabetic foot ulcer (DFU) for up to 12 weeks
Evaluate Adverse events, including severity grading using Common Terminology Criteria for Adverse Events (CTCAE v5.0), and relationship to treatment
Evaluate the safety and tolerability of Standard of Care (SoC) + CYWC628 in patients with diabetic foot ulcer (DFU) as compared to SoC only. • Adverse events, including severity grading using Common Terminology Criteria for Adverse Events (CTCAE v5.0), and relationship to treatment.
Evaluate proportion of participants with complete wound closure by 12 weeks after commencing study treatment or SoC
Evaluate the efficacy of SoC + low dose and high dose CYWC628 in wound healing of DFU, compared with SoC only. Proportion of participants with complete wound closure by 12 weeks after commencing study treatment or SoC. Complete wound closure is defined as 100% re-epithelialization with no wound drainage, as determined by the Investigator, observed at 2 visits 2 weeks apart
Evaluate percentage area reduction (PAR) of the DFU wound during the 12 week treatment period.
Evaluate the safety and tolerability of Standard of Care (SoC) + CYWC628 in patients with diabetic foot ulcer (DFU) as compared to SoC only. Percentage area reduction (PAR) of the DFU wound during the 12 week treatment period.
Evaluate the treatment time to complete wound healing of DFU by SoC + CYWC628, compared to SoC only
To assess the treatment time of wound healing of DFU by SoC + CYWC628, compared to SoC only. Time (days) to complete wound closure after commencing SoC + CYWC628 treatment or SoC only
Complete wound closure and PAR in SoC patients offered treatment at the end of the 12 week primary outcome
participants randomized to SoC only whose DFU does not heal within the Period 1 12-week treatment period will be offered up to 12 weeks treatment with SoC + CYWC628 if remaining eligible and at the discretion of the Investigator. Proportion of participants with complete wound closure by 12 weeks after commencing SoC + CYWC628. Percentage area reduction (PAR) of the DFU wound during the 12 week treatment period with SoC + CYWC628.
Evaluate DFU recurrence rate in patients with successful wound healing within 12 weeks of study treatment
To assess the recurrence rate of treated DFU at the same site, after successful wound healing within 12 weeks of study treatment (Period 1 only). Proportion of participants reporting a recurrence of DFU at the same site within 6 months of original complete wound healing (last treatment). Time to recurrence of DFU within 6 months of complete wound healing (last treatment).
Evaluate improvement in vascularization in patients administered SoC + CYWC628
To assess if DFU treatment with SoC + CYWC628 improves vascularization and thereby circulation. Ankle brachial index (ABI) measurements compared to baseline. At each treatment visit, proportion of participants with ABI in each of categories: normal (1.0-1.4), borderline (0.91-0.99), abnormal (PAD) (\<0.90), Non-compressible arteries (\>1.40).
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