Status:
COMPLETED
Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU II)
Lead Sponsor:
BioTissue Holdings, Inc
Conditions:
Diabetic Foot Infection
Non-healing Wound
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 c...
Detailed Description
This trial is designed as a confirmatory study of the benefits and risks of TTAX01 when used in the treatment of Wagner Grades 3 and 4 DFU. Experience with the use of a cryopreserved umbilical cord (U...
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, 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 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
- 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
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 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 contraceptive device; 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
Key Trial Info
Start Date :
November 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 24 2025
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT04450693
Start Date
November 20 2020
End Date
March 24 2025
Last Update
April 1 2025
Active Locations (16)
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1
LakeView Clinical Research
Guntersville, Alabama, United States, 35976
2
Banner University Medical Center Tucson
Tucson, Arizona, United States, 85724
3
Clemente Clinical Research
Los Angeles, California, United States, 90033
4
VA Northern California Health Care System
Mather, California, United States, 95655