Phase 2 Pilot Trial of Subjects With Complex Non-healing Diabetic Foot Ulcers Treated With Standard Care Plus Cryopreserved Umbilical Cord Allograft (TTAX01)

Completed · Phase 2

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

In brief

It is hypothesized that application of the human placental umbilical cord tissue TTAX01 to the surface of a well debrided, complex diabetic foot ulcer will, with concomitant management of infection, result in a higher proportion of wounds showing complete healing within 16 weeks of initiating therapy.

Key facts

Study ID

NCT03230175

Run by

BioTissue Holdings, Inc

People needed

32

Starts

2017-10-04

Expected to finish

2019-04-01

Last updated by the study team

2021-06-15

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, or lateral or medial surface of the foot
• The subject has an index ulcer with visible margins having an area ≥1.0 cm2 to ≤ 10.0 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 Ankle Brachial Index ≥ 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

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 glycated hemoglobin A1c (HbA1c) level of > 12%
• The subject has a serum albumin level ≤ 2.0 g/dL
• The subject has a white blood cell count < 2.0 x109/L, neutrophils < 1.0 x109/L, or platelets < 100 x109/L
• 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's index ulcer is over an active 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

Where it is running

• Banner University Medical Center — Phoenix, Arizona, United States
• UCLA Olive View — Sylmar, California, United States
• University of Miami — Miami, Florida, United States
• Village Podiatry Centers — Smyrna, Georgia, United States
• Rosalind Franklin University — North Chicago, Illinois, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• St Luke's-Roosevelt Hospital Center — New York, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Futuro Clinical Trials, LLC — McAllen, Texas, United States
• Carilion Clinic — Roanoke, Virginia, United States

Full record on ClinicalTrials.gov

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