Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU II)
Phase 3 study will look at 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. The study will look at the application of human placental umbilical cord tissue to the surface of a well debrided, complex diabetic foot ulcer (DFU) will, with concomitant management of infection, result in a higher rate of wounds showing omplete healing within 25 weeks of initiating therapy, compared with
standard care alone.
Study phase: III
Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.
Inclusion:
The subject is male or female, at least 18 years of age
The subject has confirmed diagnosis of Type I or Type II diabetes
The subject's ulcer is located on the plantar surface, inter digital, heel, lateral or medial surface of the foot extends beyond the dermis, into subcutaneous tissue with evidence of exposed bone, tendon, muscle and/or joint capsule
The subject presents with history, signs or symptoms leading to a clinical suspicion of osteomyelitis
The subject's index ulcer can not be addressed by primary closure through the completion of the initial or staged surgical procedur
Primary disease category: Diabetes & Endocrine System
Sponsor: TissueTech Inc
Protocol number: TTAX
Projected enrollment dates: November 2020 to December 2023
Official study title: A Multicenter Phase 3 Confirmatory Trial of Biotherapy using Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Nonhealing Diabetic Foot Ulcers (AMBULATE DFU II)
ClinicalTrials.gov page:
http://www.clinicaltrials.gov/show/NCT04450693