Condition: Diabetic Foot Infection · Non-healing Wound · Non-healing Diabetic Foot Ulcer · Sponsor: BioTissue Holdings, Inc
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.
Contact details are listed per location below or on the registry record.
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| Center for Clinical Research, Inc | San Francisco, California, United States | — |
| UCLA Olive View | Sylmar, California, United States | — |
| University of Miami | Miami, Florida, United States | — |
| Paley Orthopedic & Spine Institute | West Palm Beach, Florida, United States | — |
| Rosalind Franklin University | North Chicago, Illinois, United States | — |
| Ochsner Medical Center | New Orleans, Louisiana, United States | — |
| Mount Sinai West | New York, New York, United States | — |
| University of North Carolina | Chapel Hill, North Carolina, United States | — |
| University Hospitals Richmond Medical Center | Richmond Heights, Ohio, United States | — |
| Oregon Health & Science University | Portland, Oregon, United States | — |
| Vanderbilt University Medical Center | Nashville, Tennessee, United States | — |
| JPS | Fort Worth, Texas, United States | — |
+ 4 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04176120