Status: Not yet recruiting
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
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.
Participants needed: 120
Trial details
Phase: Phase 1, Phase 2Age: 18-80Biological sex: AllType: InterventionalSponsor: FibroBiologicsUpdated: Jul 31, 2025
Eligibility criteria
Males or females aged 18 to 80 years inclusive at time of informed consent. [+14]
The DFU had been previously treated, or is being treated, with growth factors, s... [+15]