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NCT07096934
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
Conditions: Diabetic Foot Ulcer (DFU)
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 120
Sponsor: FibroBiologics
Location: Coffs Harbour Health Campus Coffs Harbour New South Wales
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.
Eligibility Criteria
Inclusion Criteria:
1. Males or females aged 18 to 80 years inclusive at time of informed consent.
2. Diagnosed/confirmed Type 1 or 2 diabetes mellitus.
3. 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.
4. DFU Wagner Grade 1 or 2.
5. DFU present for 12 to 52 weeks at time of Screening.
6. DFU cross-sectional area of 50 to 1000 mm2 at Screening and Day 1.
7. Resting ankle brachial index (ABI) ≥0.6 and ≤1.2, or toe pressure \>30 mmHg.
8. HbA1c \
Source: ClinicalTrials.gov (NCT07096934). StuddyBuddy aggregates publicly available trial information.
