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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

NCT07096934 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-07-31

No results posted yet for this study

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.

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 & Collaborators

  • FibroBiologics

    lead OTHER

Principal Investigators

  • Hamid Khoja Chief Scientific Officer, Ph.D. · FibroBiologics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2026-03-31
Completion
2027-03-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07096934 on ClinicalTrials.gov