A Phase 1/2 interventional study of Standard of Care (SOC) and SoC + Low dose CYWC628 in Diabetic Foot Ulcer (DFU), sponsored by FibroBiologics. Recruiting at 9 sites in Australia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by FibroBiologics · Phase 1/2, Interventional, and Treatment
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.
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.
Period 1:
After providing voluntary, written informed consent, participants will undergo screening assessments according to the schedule of assessments (SOA). The participant's DFU will be sharply debrided (as needed), dressed with SoC and offloaded. If there is evidence of infection, a skin pathogen test will be performed and topical or systemic antibiotic or antifungal may be administered until the infection is cleared or is at a level defined as acceptable in the eligibility criteria.
After the Screening visit (or the visit at which any DFU infection is deemed cleared or is at a level defined as acceptable in the eligibility criteria), the participant will return two (2) weeks later to confirm eligibility. If the DFU wound area has not decreased in size ≥30% and the participant remains eligible, they will be randomized on Day 1 to one of 3 treatment groups: SoC + low dose CYWC628, SoC + high dose CYWC628, or SoC only.
The treatment period is comprised of weekly visits for allocated study treatment for up to 12 weeks (i.e., up to 12 treatments). At each visit, the DFU will be assessed by the Investigator and measured using the eKare inSight® electronic image capture application, and ABI determined. Vital signs and clinical laboratory testing will be performed at each study visit, from Day 1 until the Week 12 visit or the visit at which the DFU is deemed healed by the Investigator (whichever visit occurs first). Adverse events and concomitant medications/therapies will be recorded at each visit.
The Safety Review Committee (SRC) will review the safety data from the first 2 weeks treatment of the first 20 randomized participants (sentinel group), i.e., data from Day 1, Week 1 and Week 2 visits. If safety and tolerability is confirmed as acceptable, enrolment of the remaining participants will proceed. An interim analysis will be performed when at least 28 randomized participants per treatment group have completed the Week 6 visit, to assess primary safety and efficacy endpoints at Week 6.
Period 1 participants whose DFU heals within the 12-week treatment period (regardless of treatment) will attend 2 follow-up visits 2 weeks apart to confirm healing and attend the end of study visit (EOS) at 6 months post-last treatment. At each follow-up visit, any recurrence of the DFU at the same site will be assessed and recorded.
Period 1 participants randomized to SoC + CYWC628 whose DFU does not heal within 12 weeks, and participants randomized to SoC only whose DFU does not heal within 12 weeks and do not continue with Period 2 treatment with SoC + CYWC628, will revert to their treating physician's care for DFU. Safety follow-up visits for SoC + CYWC628-treated participants with non-healed DFU will be performed at Weeks 14 and 16, with the Week 16 visit considered the EOS for these participants. Safety follow-up visits for SoC only-treated participants with non-healed DFU will be performed at the Week 16 visit only, with this visit considered the EOS for these participants.
Period 2:
Period 1 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.
Before participants receive Period 2 treatment with SoC + CYWC628, eligibility must be re-confirmed (Period 1 Week 12 visit assessments may be used with addition of toe systolic pressure measurement; serology and ECG not required unless considered necessary by Investigator). The same 2-week period required between Period 1 Screening and Day 1 randomization will also apply between the Period 1 Week 12 visit and first administration of Period 2 SoC + CYWC628 treatment. Procedures for treatment for infected DFU described for Period 1 Screening will also be applied in Period 2. Eligible participants will receive a dose of CYWC628 if a safe and effective dose has been determined from the interim analysis. Treatment with SoC + CYWC628 and follow-up visits in Period 2 will be as described for Period 1, except that the EOS will be performed 4 weeks after DFU deemed healed by the Investigator (or Period 2 Week 16 visit if unhealed in 12 weeks). Period 2 will not proceed if not approved by the SRC.
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's planned enrollment of 120 is above the median of 60 across 826 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →FibroBiologics is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Non-infected DFU (i.e., Infectious Diseases Society of America [IDSA] International Working Group on the Diabetic Foot [IWGDF] Classification 1/Uninfected) OR, at the discretion of the Investigator, DFU infection of IWGDF/IDSA Classification 2/Mild, at least within 2 weeks before and on Day 1.
At the discretion of the Investigator, if the DFU infection is IWGDF/IDSA Classification 3/ Moderate at Screening, the Screening period may be extended to allow time to reduce the infection to IWGDF/IDSA Classification 2/ Mild or 1/ no infection at least 2 weeks before randomization on Day 1. Otherwise, DFU infection of IWGDF/IDSA Classification ≥3 and/or any infection involving bone (osteomyelitis), is exclusionary.
If there is evidence of infection during the Screening period (i.e., only IWGDF/IDSA Classification 2/ Moderate or 3/ Severe), the following will be performed:
Exclusion Criteria:
Standard of care used for the treatment of diabetic foot ulcers once weekly for up to 12 weeks.
Other: Standard of Care (SOC)
standard of care (SoC) + low dose CYWC628 applied once weekly to diabetic foot ulcer (DFU) for up to 12 weeks:
Biological: SoC + Low dose CYWC628
standard of care + high dose CYWC628 applied once weekly to diabetic foot ulcer (DFU) for up to 12 weeks:
Biological: SoC + High dose CYWC628
The participant's DFU will be sharply debrided (as needed), dressed with SoC and offloaded.
The 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
The 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.
Time frame: from enrollment to the end of the treatment at 12 weeks
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
Time frame: from enrollment to the end of the treatment at 12 weeks
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.
Time frame: from enrollment to the end of the treatment at 12 weeks
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
Time frame: from enrollment to the end of the treatment at 12 weeks
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.
Time frame: from enrollment to the end of the treatment at 12 weeks
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).
Time frame: 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).
Time frame: from enrollment to the end of the treatment at 12 weeks
Plan to share: Yes — we will share de-identified data collected for the primary and secondary outcomes of the study.
Supporting information: Study protocol, Sap, Icf, Csr
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