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

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

March 31, 2026

Study Completion Date

March 31, 2027

Conditions
Diabetic Foot Ulcer (DFU)
Interventions
OTHER

Standard of Care (SOC)

The participant's DFU will be sharply debrided (as needed), dressed with SoC and offloaded.

BIOLOGICAL

SoC + Low dose CYWC628

The participant's DFU will be sharply debrided (as needed), dressed with SoC and offloaded. Low dose CYWC628 applied once weekly to diabetic foot ulcer (DFU) for up to 12 weeks

BIOLOGICAL

SoC + High dose CYWC628

The participant's DFU will be sharply debrided (as needed), dressed with SoC and offloaded. High dose CYWC628 applied once weekly to diabetic foot ulcer (DFU) for up to 12 weeks

Sponsors

Lead Sponsor

All Listed Sponsors
lead

FibroBiologics

OTHER