Controlled Trial to Evaluate the Safety and Efficacy of CYWC628 (Human Dermal Fibroblast Spheroid… (NCT07096934) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Controlled Trial to Evaluate the Safety and Efficacy of CYWC628 (Human Dermal Fibroblast Spheroids) for the Treatment of Refractory Diabetic Foot Ulcers Compared With Standard of Care
120 participantsStarted 2025-09
Plain-language summary
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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. DFU present for 12 to 52 weeks at time of Screening.
. DFU cross-sectional area of 50 to 1000 mm2 at Screening and Day 1.
. Resting ankle brachial index (ABI) ≥0.6 and ≤1.2, or toe pressure \>30 mmHg.
. HbA1c \<9%.
Exclusion criteria
0. If participant of child bearing potential, must have a negative serum pregnancy test at screening and negative urine pregnancy test pre-first treatment on Day 1, and must agree to remain sexually abstinent, or use medically effective contraception (refer to Appendix 11.1), or have a partner who is sterile or same-sex, from Screening until at least 60 days after the last dose of study treatment. Males must not be planning to father children or donate sperm for the duration of the study and for at least 90 days after the last dose of study product.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluate Adverse events, including severity grading using Common Terminology Criteria for Adverse Events (CTCAE v5.0), and relationship to treatment
Timeframe: from enrollment to the end of the treatment at 12 weeks
2
Evaluate proportion of participants with complete wound closure by 12 weeks after commencing study treatment or SoC
Timeframe: from enrollment to the end of the treatment at 12 weeks
3
Evaluate percentage area reduction (PAR) of the DFU wound during the 12 week treatment period.
Timeframe: from enrollment to the end of the treatment at 12 weeks
1. Understands and is able and willing to participate and comply with study requirements including attending study visits and follow-up.
. 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. .
. DFU with exposure of bone and/or joint capsule.
. Active osteomyelitis, cellulitis, soft tissue infection, or Charcot's arthropathy present on the affected foot or limb containing the DFU, or DFU infection IWGDF/IDSA Classification 4/ Severe, or DFU infection IWGDF/IDSA Classification 3/ Moderate at Screening that cannot be reduced to Classification 2/ Mild or Classification 1/ No infection with treatment.