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Study identifier: NCT04176120 Synced from ClinicalTrials.gov · July 28, 2026
● Completed

Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU)

Condition: Diabetic Foot Infection · Non-healing Wound · Non-healing Diabetic Foot Ulcer  ·  Sponsor: BioTissue Holdings, Inc

PhasePhase 3
Planned participants220
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

It is hypothesized that application at 4-week or greater intervals of the human placental umbilical cord tissue TTAX01 to the surface of a well debrided, complex diabetic foot ulcer (DFU) will, with concomitant management of infection, will result in a higher rate of wounds showing complete healing within 26 weeks of initiating therapy, compared with standard care alone. This confirmatory Phase 3 study examines a population of diabetic foot ulcer patients having adequate perfusion, with or without neuropathy, and a high suspicion of associated osteomyelitis in a complex, high grade wound.

This description comes directly from the study's public registry record.

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Contact details are listed per location below or on the registry record.

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Locations (16)

Center for Clinical Research, IncSan Francisco, California, United States
UCLA Olive ViewSylmar, California, United States
University of MiamiMiami, Florida, United States
Paley Orthopedic & Spine InstituteWest Palm Beach, Florida, United States
Rosalind Franklin UniversityNorth Chicago, Illinois, United States
Ochsner Medical CenterNew Orleans, Louisiana, United States
Mount Sinai WestNew York, New York, United States
University of North CarolinaChapel Hill, North Carolina, United States
University Hospitals Richmond Medical CenterRichmond Heights, Ohio, United States
Oregon Health & Science UniversityPortland, Oregon, United States
Vanderbilt University Medical CenterNashville, Tennessee, United States
JPSFort Worth, Texas, United States

+ 4 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT04176120