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Diabetic Foot InfectionPhase 3NCT04176120

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

A Phase 3 study testing TTAX01 in people with Diabetic Foot Infection and Non-healing Wound, run by BioTissue Holdings, Inc at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 concomitant management of infection, will result in a higher rate of wounds showing complete healing within 26 weeks of… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
TTAX01
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
16 sitesUnited States
Study dates
1 Jul 2020to 12 Jun 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • JPS

    Fort Worth, Texas, 76104

  • Futuro Clinical Trials, LLC

    McAllen, Texas, 78501

  • University of Miami

    Miami, Florida, 33125

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

  • Mount Sinai West

    New York, New York, 10019

  • Rosalind Franklin University

    North Chicago, Illinois, 60064

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • University Hospitals Richmond Medical Center

    Richmond Heights, Ohio, 44143

  • Carilion Clinic

    Roanoke, Virginia, 24013

  • Bio-X-Cell Research

    San Antonio, Texas, 78224

  • Center for Clinical Research, Inc

    San Francisco, California, 94117

  • Foot & Ankle Institute

    St. George, Utah, 84470

  • UCLA Olive View

    Sylmar, California, 91342

  • Paley Orthopedic & Spine Institute

    West Palm Beach, Florida, 33407

Other trials in United States

About this study

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)

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.

Read the 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 (UC) product in treating such wounds, both prior to this Investigational New Drug application (IND) and under this IND, has indicated that a frequency of application of no shorter than every 4 weeks is associated with better than expected outcomes. Although treatment cannot be blinded, a "standard care only" arm is included to control for the benefits of aggressive baseline debridement combined with aggressive (6 weeks systemic) antibiotics. Current treatment guidelines indicate that aggressive debridement plus 1-2 weeks of antibiotics, or, minor debridement plus 6 weeks of antibiotics, would produce equivalent outcomes, although the evidence is not strong. By utilizing both maximum debridement and maximum antimicrobial therapy, the standard care described in this protocol may result in healing rates somewhat superior to current standard practice.

The design of this confirmatory study is matched to the design of the Phase 2 efficacy study TTCRNE-1501, with the exception of extending the primary endpoint from 16 to 26 weeks, and utilizing a proportional risk analysis rather than a landmark analysis. This design consideration is based on analysis of previous studies, and a desire to fold data from every visit into the primary analysis, rather than generating an excessive number of secondary endpoints.

Being tested
TTAX01, Standard Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TTAX01Biological

    TTAX01 is a cryopreserved human umbilical cord product derived from donated human placental tissue following healthy, live, caesarian section, full-term births after determination of donor eligibility and placenta suitability. TTAX01 is manufactured by TissueTech Inc. utilizing a proprietary CRYOTEK® process, which devitalizes the living cells but retains the natural structural and biological characteristics relevant to this tissue. TTAX01 is aseptically processed in compliance with current Good Tissue Practices (cGTP). TTAX01 will be manufactured in various sizes, stored in a medium of lactated Ringer's/glycerol (1:1).

  • Standard CareOther

    Standard care is defined in this protocol to consist of the following:

    • Debridement;
    • Wound cleansing, using sterile saline, a non-ionic cleanser or a hypochlorous solution. Antiseptic agents including hydrogen peroxide, acetic acid, chlorhexidine, povidone/iodine, and cetrimide should not be used. Topical antimicrobials and silver dressings are also prohibited;
    • Primary wound dressings including a non-adherent, standard foam pad with or without a hydrogel beneath the dressing, or and alginate dressing, as is appropriate to maintain a moist wound environment while managing exudate;
    • A secondary retention bandage appropriate to the amount of wound exudate, so as to avoid maceration of the peri-wound skin;
    • Off-loading device appropriate to the location of wound with full length boot or total contact cast (unless not appropriate where a substitute off-loading device can be made with sponsor approval); and,
    • Appropriate use of systemic antibiotics.
Study groups in NCT04176120
Study groupRoleWhat they receive
TTAX01ExperimentalTTAX01 plus standard care
Receives: Biological: TTAX01; Other: Standard Care
ControlOtherStandard Care alone
Receives: Other: Standard Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete wound healing

    Time from baseline to initial observation of healing, where healing has been confirmed at two consecutive visits each two weeks apart.

    Measured: over 26 weeks

Secondary outcomes (4)

  1. Complete wound healing

    Proportion of wound healed

    Measured: by Week 50

  2. Wound durability

    Proportion of wounds that re-ulcerate

    Measured: by Week 50

  3. Limb preservation

    proportion of minor and major amputations following the initial procedure

    Measured: by Week 50

  4. 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

    Measured: Baseline to End of Study (approximately 50 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2019
  2. Study start1 Jul 2020
  3. Primary completion25 Jan 2024
  4. Study completion12 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
220 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04176120
Sponsor's protocol ID
TTAX01-CR003
Status last verified
Jun 2024
First submitted
20 Nov 2019
Last updated
14 Jun 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TTAX01 in people with Diabetic Foot Infection and Non-healing Wound, run by BioTissue Holdings, Inc at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete wound healing (time frame: over 26 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04176120.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.

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