A Study to Improve Healing of Diabetic Foot Sores
Diabetic foot ulcers (DFUs) are a serious and common complication of diabetes, affecting millions of people worldwide. These chronic wounds can be painful, slow to heal, and may lead to infection, hospitalization, or even amputation. Despite current treatments, many DFUs remain unresponsive, creating an urgent need for new therapies.
This study is investigating a potential topical treatment called CYWC628. The treatment aims to support wound healing by promoting tissue regeneration, reducing inflammation, and improving blood flow to the affected area. Participants in this study will be randomly assigned to receive either standard wound care alone or standard care plus the investigational CYWC628 treatment.
The study will help researchers understand how safe and effective CYWC628 is for treating hard-to-heal diabetic foot ulcers.
Study details:
Depending on which group you are assigned to, the study would require you to come to the. clinic for up to 16 visits over a maximum period of 9 months, or up to 32 visits over a. maximum period of 8-months.
Visits will range from 30 minutes to 3 hours. At the visits we. will check your medical history, assess your wound, conduct physical examinations and.
administer the treatment if applicable. You will be reimbursed for your time in the research. study.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- Males or females aged 18 to 80 years inclusive at time of informed consent.
- Diagnosed/confirmed Type 1 or Type 2 diabetes mellitus.
- Presence of diabetic foot ulcer (DFU) at or below the level of the malleolus, 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%.
- Non-infected DFU (IDSA/IWGDF Classification 1) OR, at the discretion of the Investigator, DFU infection of IWGDF/IDSA Classification 2/Mild within 2 weeks before and on Day 1. If Classification 3/Moderate at Screening, infection may be reduced to Mild or No infection at least 2 weeks before randomization. DFU infection ≥3 or any osteomyelitis is exclusionary.
- If infection is present during Screening (Classification 2/Moderate or 3/Severe): skin pathogen testing will be performed; systemic or topical antibiotics/antifungals may be used as needed (systemic must stop ≥5 days before Day 1 except topical allowed); continued treatment until infection improves; and sharp debridement of necrotic tissue/slough/biofilm as needed.
- For participants of childbearing potential: negative pregnancy test at screening and prior to first dose, and agreement to use contraception or remain abstinent from Screening until 60 days after last dose. Males must not father a child or donate sperm during the study and for 90 days after.
- Must be willing and able to comply with all study procedures, visits, and follow-up requirements.
Exclusion criteria
- 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.
- Active healing and reduction of wound area ≥30% during the two-week period before Day 1.
- Known allergy to topical dressings, any of the study treatment components, and/or to gentamicin or other aminoglycosides.
- Use of systemic antibiotics or antifungals for treatment of or prophylaxis for DFU infection within 5 days before Day 1, and/or if such use is considered by the Investigator likely to be required during the study treatment period. Systemic antibiotic or antifungal use for other indications is not exclusionary.
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer considered treated and cured) within 5 years of screening, regardless of whether there is no evidence of local recurrence or metastasis. Basal cell carcinomas of the skin are also exclusionary if diagnosed within 6 months before screening. If there is suspicion of skin cancer, a biopsy may be performed during screening for confirmation.
- Pregnant or breastfeeding, or a male participant planning to father children or donate sperm during the study and for 90 days after last dose of study treatment.
- Current smoker of tobacco products and/or active user of nicotine replacement products including but not limited to nicotine gum, patches, or vaping.
- Current alcohol misuse as determined by the Investigator, and/or positive alcohol breath test at screening or pre-first treatment (no re-test permitted).
- Substance use disorder of any severity as determined by the Investigator, including any use of illicit drugs or other addiction which might interfere with the ability to comply with study procedures in the opinion of the Investigator; positive urine drug test at screening or pre-first treatment (tricyclic antidepressants, opioids, cannabidiols [CBDs] and benzodiazepines are not exclusionary if prescribed by a physician and consistent with medical history). One re-test permitted for urine drug test where justified in the opinion of the Investigator (e.g., false positive suspected).
- Any other condition or situation that, in the opinion of the Investigator, would compromise the participant’s ability to comply with study requirements.
- Known history of poor compliance with medical treatments.
Eligibility
Age eligible for study : Aged 18 years or older.
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start: 2026-03-02
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- Phase I / Phase IIPhase IPhase II
Study ID
CC-CYWC628-DFU
Intervention or treatment
No interventions found
Conditions
- Diabetic Foot Ulcer Study
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
Wollongong - Canopy Clinical Research
Select from list below to view details:
Wollongong - Canopy Clinical Research
Wollongong, New South Wales (NSW), Australia
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Who is running the clinical trial?
FibroBiologics, Inc.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
What is the study measuring?
Primary Outcome
Secondary Outcome
References
Clinical Trials Gov: A Study to Improve Healing of Diabetic Foot SoresOther trials to consider
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