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

Completed · Phase 3

Conditions studied: Diabetic Foot Infection, Non-healing Wound, Non-healing Diabetic Foot Ulcer

In brief

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.

Key facts

Study ID

NCT04176120

Run by

BioTissue Holdings, Inc

People needed

220

Starts

2020-07-01

Expected to finish

2024-06-12

Last updated by the study team

2024-06-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The subject has signed the informed consent form
• The subject is male or female, at least 18 years of age inclusive at the date of Screening
• The subject has confirmed diagnosis of Type I or Type II diabetes
• The subject's index ulcer is located on the plantar surface, inter digital, heel, lateral or medial surface of the foot
• The subject has an index ulcer with visible margins having an area ≤ 12.0 cm2 when measured by the electronic measuring device at Screening
• The subject's index ulcer 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 in the opinion of the Investigator supported by positive Probe to Bone (PTB) and any of the following: radiographic (X-ray, Magnetic Resonance Imaging (MRI), or bone scan) or evidence of bone necrosis
• The subject has an ABI ≥ 0.7 to ≤ 1.3 or TcPO2 ≥ 40 mmHg on the dorsum of the affected foot, or Great Toe Pressure ≥ 50 mmHg
• The subject is under the care of a physician for the management of Diabetes Mellitus
• The subject is willing to return for all mandatory visits as defined in the protocol
• The subject is willing to follow the instructions of the trial Investigator

You may not qualify if…

• The subject's index ulcer is primarily located on the dorsal surface of the foot
• The subject's index ulcer can be addressed by primary closure through the completion of the initial or staged surgical procedure
• The subject has a contralateral major amputation of the lower extremity
• The subject has a glycated hemoglobin A1c (HbA1c) level of > 12%
• The subject has been on oral steroid use of > 7.5 mg daily for greater than seven (7) consecutive days in 30 days before Screening
• The subject has been on parenteral corticosteroids, or any cytotoxic agents for seven consecutive days in the period of 30 days before Screening
• The subject is currently taking the type 2 diabetes medicine canagliflozin (Invokana™, Invokamet™, Invokamet XR™)
• The subject has malignancy or a history of cancer, other than non-melanoma skin cancer, in five years before Screening
• The subject is pregnant
• The subject is a nursing mother
• The subject is a woman of child-bearing potential who is unwilling to avoid pregnancy or use an appropriate form of birth control (adequate birth control methods are defined as: topical, oral, implantable, or injectable contraceptives; spermicide in conjunction with a barrier such as a condom or diaphragm; intrauterine device (IUD); or surgical sterilization of partner).
• The subject is unable to sustain off-loading as defined by the protocol
• The subject has an allergy to primary or secondary dressing materials used in this trial
• The subject has an allergy to glycerol
• The subject's index ulcer is over an acute Charcot deformity
• The subject has had previous use of NEOX®, CLARIX®, or TTAX01 applied to the index ulcer
• Per Investigator's discretion the subject is not appropriate for inclusion in the trial, e.g., undergoing surgical treatments listed in the protocol or the subject currently has sepsis, i.e., life-threatening organ dysfunction caused by a dysregulated host response to infection

Where it is running

• 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
• Futuro Clinical Trials, LLC — McAllen, Texas, United States
• Bio-X-Cell Research — San Antonio, Texas, United States
• Foot & Ankle Institute — St. George, Utah, United States
• Carilion Clinic — Roanoke, Virginia, United States

Full record on ClinicalTrials.gov

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