The CYWC628 clinical trial is investigating a new treatment for people living with diabetic foot ulcers that have been difficult to heal despite standard care. Researchers want to find out whether adding CYWC628, an investigational cell-based therapy, to standard wound care can improve healing outcomes compared with standard care alone.
Why is the research being done?
Diabetic foot ulcers are a common and serious complication of diabetes. These wounds can be slow to heal and may increase the risk of infection, hospitalisation, and, in severe cases, amputation. Despite current treatments, many ulcers remain unhealed for months or return after healing.
CYWC628 is an investigational treatment made from human dermal fibroblast spheroids. Fibroblasts are natural cells found in the skin that play an important role in wound healing and tissue repair. They help produce connective tissue, support new blood vessel growth, and release substances that assist the body’s healing processes.
Researchers believe that applying CYWC628 directly to a diabetic foot ulcer may help support wound healing by promoting tissue repair, improving blood vessel formation, and encouraging healthy wound closure. Laboratory and animal studies have shown promising results, but CYWC628 has not previously been tested in humans.
This study will compare:
- Standard wound care alone
- Standard wound care plus a lower dose of CYWC628
- Standard wound care plus a higher dose of CYWC628
Participants will attend regular clinic visits where their ulcer will be assessed, measured, and treated. Researchers will monitor safety, wound healing, and overall outcomes throughout the study.
Who can participate in the research study?
You may be able to take part if you:
- Are aged between 18 and 85 years
- Have type 1 or type 2 diabetes
- Have a diabetic foot ulcer that has been present for at least 12 weeks
- Meet other study-specific eligibility criteria determined by the research team
What will study participants be asked to do?
Participants will attend regular clinic visits where their ulcer will be assessed, measured, and treated. Researchers will monitor safety, wound healing, and overall outcomes throughout the study.
How to participate
If you would like to learn more about this study or find out whether you may be eligible, please contact the HNE Clinical Trials team. Participation is entirely voluntary, and speaking with the study team does not obligate you to take part.
If you are interested in participating, please contact:
Ashley Kite, Clinical Trial Coordinator, Hunter New England Clinical Trials
Ph: 0467252519
E: [email protected]
