Not Yet RecruitingPhase 1/2

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

120 participantsStarted 2025-09

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Males or females aged 18 to 80 years inclusive at time of informed consent.
✓. Diagnosed/confirmed Type 1 or 2 diabetes mellitus.
✓. 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.
✓. DFU Wagner Grade 1 or 2.
✓. DFU present for 12 to 52 weeks at time of Screening.
✓. DFU cross-sectional area of 50 to 1000 mm2 at Screening and Day 1.
✓. Resting ankle brachial index (ABI) ≥0.6 and ≤1.2, or toe pressure \>30 mmHg.
✓. HbA1c \<9%.

Exclusion criteria

✕0. If participant of child bearing potential, must have a negative serum pregnancy test at screening and negative urine pregnancy test pre-first treatment on Day 1, and must agree to remain sexually abstinent, or use medically effective contraception (refer to Appendix 11.1), or have a partner who is sterile or same-sex, from Screening until at least 60 days after the last dose of study treatment. Males must not be planning to father children or donate sperm for the duration of the study and for at least 90 days after the last dose of study product.
✕1. Understands and is able and willing to participate and comply with study requirements including attending study visits and follow-up.
✕. The DFU had been previously treated, or is being treated, with growth factors, stem cells, or any equivalent preparation within 8 weeks before Screening.
✕. Enrolment in another interventional clinical foot ulcer healing trial within 4 weeks before Screening, or participation in any other interventional research study within 8 weeks before screening.
✕. Additional wound(s) within 3 cm of the study target wound.
✕. History of conditions that may impair wound healing in the opinion of the Investigator, for example, autoimmune disorders, renal failure patients on dialysis, or medications that impair the healing process. .
✕. DFU with exposure of bone and/or joint capsule.
✕. Active osteomyelitis, cellulitis, soft tissue infection, or Charcot's arthropathy present on the affected foot or limb containing the DFU, or DFU infection IWGDF/IDSA Classification 4/ Severe, or DFU infection IWGDF/IDSA Classification 3/ Moderate at Screening that cannot be reduced to Classification 2/ Mild or Classification 1/ No infection with treatment.

What they're measuring

Evaluate Adverse events, including severity grading using Common Terminology Criteria for Adverse Events (CTCAE v5.0), and relationship to treatment

Timeframe: from enrollment to the end of the treatment at 12 weeks

Evaluate proportion of participants with complete wound closure by 12 weeks after commencing study treatment or SoC

Timeframe: from enrollment to the end of the treatment at 12 weeks

Evaluate percentage area reduction (PAR) of the DFU wound during the 12 week treatment period.

Timeframe: from enrollment to the end of the treatment at 12 weeks

Trial details

NCT IDNCT07096934

SponsorFibroBiologics

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03

Contact for this trial

Hamid Khoja Chief Scientific Officer, Ph.D.

281-671-5153 hamid.khoja@fibrobiologics.com

View on ClinicalTrials.gov More Diabetic Foot Ulcer (DFU) trials

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Males or females aged 18 to 80 years inclusive at time of informed consent.
✓. Diagnosed/confirmed Type 1 or 2 diabetes mellitus.
✓. 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.
✓. DFU Wagner Grade 1 or 2.
✓. DFU present for 12 to 52 weeks at time of Screening.
✓. DFU cross-sectional area of 50 to 1000 mm2 at Screening and Day 1.
✓. Resting ankle brachial index (ABI) ≥0.6 and ≤1.2, or toe pressure \>30 mmHg.
✓. HbA1c \<9%.

Exclusion criteria

✕0. If participant of child bearing potential, must have a negative serum pregnancy test at screening and negative urine pregnancy test pre-first treatment on Day 1, and must agree to remain sexually abstinent, or use medically effective contraception (refer to Appendix 11.1), or have a partner who is sterile or same-sex, from Screening until at least 60 days after the last dose of study treatment. Males must not be planning to father children or donate sperm for the duration of the study and for at least 90 days after the last dose of study product.
✕1. Understands and is able and willing to participate and comply with study requirements including attending study visits and follow-up.
✕. The DFU had been previously treated, or is being treated, with growth factors, stem cells, or any equivalent preparation within 8 weeks before Screening.
✕. Enrolment in another interventional clinical foot ulcer healing trial within 4 weeks before Screening, or participation in any other interventional research study within 8 weeks before screening.
✕. Additional wound(s) within 3 cm of the study target wound.
✕. History of conditions that may impair wound healing in the opinion of the Investigator, for example, autoimmune disorders, renal failure patients on dialysis, or medications that impair the healing process. .
✕. DFU with exposure of bone and/or joint capsule.
✕. Active osteomyelitis, cellulitis, soft tissue infection, or Charcot's arthropathy present on the affected foot or limb containing the DFU, or DFU infection IWGDF/IDSA Classification 4/ Severe, or DFU infection IWGDF/IDSA Classification 3/ Moderate at Screening that cannot be reduced to Classification 2/ Mild or Classification 1/ No infection with treatment.

What they're measuring

Evaluate Adverse events, including severity grading using Common Terminology Criteria for Adverse Events (CTCAE v5.0), and relationship to treatment

Timeframe: from enrollment to the end of the treatment at 12 weeks

Evaluate proportion of participants with complete wound closure by 12 weeks after commencing study treatment or SoC

Timeframe: from enrollment to the end of the treatment at 12 weeks

Evaluate percentage area reduction (PAR) of the DFU wound during the 12 week treatment period.

Timeframe: from enrollment to the end of the treatment at 12 weeks