Diabetic Foot Infection Clinical Trial
Official title:
A Multicenter Phase 3 Trial of Biotherapy Using Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU)
Verified date | June 2024 |
Source | Tissue Tech Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 220 |
Est. completion date | June 12, 2024 |
Est. primary completion date | January 25, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina | Chapel Hill | North Carolina |
United States | JPS | Fort Worth | Texas |
United States | Futuro Clinical Trials, LLC | McAllen | Texas |
United States | University of Miami | Miami | Florida |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | Ochsner Medical Center | New Orleans | Louisiana |
United States | Mount Sinai West | New York | New York |
United States | Rosalind Franklin University | North Chicago | Illinois |
United States | Oregon Health & Science University | Portland | Oregon |
United States | University Hospitals Richmond Medical Center | Richmond Heights | Ohio |
United States | Carilion Clinic | Roanoke | Virginia |
United States | Foot & Ankle Institute | Saint George | Utah |
United States | Bio-X-Cell Research | San Antonio | Texas |
United States | Center for Clinical Research, Inc | San Francisco | California |
United States | UCLA Olive View | Sylmar | California |
United States | Paley Orthopedic & Spine Institute | West Palm Beach | Florida |
Lead Sponsor | Collaborator |
---|---|
Tissue Tech Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete wound healing | Time from baseline to initial observation of healing, where healing has been confirmed at two consecutive visits each two weeks apart. | over 26 weeks | |
Secondary | Complete wound healing | Proportion of wound healed | by Week 50 | |
Secondary | Wound durability | Proportion of wounds that re-ulcerate | by Week 50 | |
Secondary | Limb preservation | proportion of minor and major amputations following the initial procedure | by Week 50 | |
Secondary | Patient-reported mobility | compare total score on PROMIS Health Organization Neuro-QoL 'lower extremity function'; scale from 1-5; higher scores indicate better self-reported health | Baseline to End of Study (approximately 50 weeks) |
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