Status:
COMPLETED
Phase 2 Pilot Trial of Subjects With Complex Non-healing Diabetic Foot Ulcers Treated With Standard Care Plus Cryopreserved Umbilical Cord Allograft (TTAX01)
Lead Sponsor:
BioTissue Holdings, Inc
Conditions:
Non-healing Wound
Non-healing Diabetic Foot Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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, r...
Detailed Description
The hypothesis under study is that one or more applications of TTAX01 to the wound surface of a well debrided, complex diabetic foot ulcer managed with appropriate antibiotic therapy will result in a ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2019
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03230175
Start Date
October 4 2017
End Date
April 1 2019
Last Update
June 15 2021
Active Locations (11)
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1
Banner University Medical Center
Phoenix, Arizona, United States, 85006
2
UCLA Olive View
Sylmar, California, United States, 91342
3
University of Miami
Miami, Florida, United States, 33125
4
Village Podiatry Centers
Smyrna, Georgia, United States, 30082