RecruitingPhase 1Phase 2NCT07096934

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

A Prospective, Randomized, 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

Sponsor

FibroBiologics

Enrollment

120 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

Diabetic Foot Ulcer (DFU)

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called SoC + High dose CYWC628, a biological treatment called SoC + Low dose CYWC628, and others for people with diabetic foot ulcer (dfu). The study is currently recruiting participants at 9 locations. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERStandard of Care (SOC)

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

BIOLOGICALSoC + 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

BIOLOGICALSoC + 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