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

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ClinicalTrials.gov Identifier: NCT03230175
Recruitment Status : Active, not recruiting
First Posted : July 26, 2017
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Tissue Tech Inc.

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, result in a higher proportion of wounds showing complete healing within 16 weeks of initiating therapy.

Condition or disease Intervention/treatment Phase
Non-healing Wound Non-healing Diabetic Foot Ulcer Diabetic Foot Infection Biological: TTAX01 Phase 2

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 higher probability of complete healing than would be expected from management with standard care alone. In this open label Phase 2 pilot trial, all subjects will receive the intervention over a maximum period of 16 weeks. Eligible consenting subjects will undergo a baseline aggressive debridement in the operating room to remove infected and devitalized bone and soft tissue. TTAX01 will be applied to the debrided wound bed at baseline, and if healing is not evident, it will be applied again at 4 week intervals. At each weekly visit the wound will be further debrided as necessary.

Consenting subjects who qualify for enrollment will undergo an aggressive surgical debridement at the baseline visit, including biopsies of bone for histology and microbiologic testing at the start and completion of debridement. Systemic antibiotics will be given empirically, with adjustments made on the basis of culture and sensitivity results. New or recurrent infections will be managed with additional debridement and adjustment or addition of appropriate systemic antibiotics. The test article, TTAX01, will be sutured to the debrided wound bed at baseline and again at 4 week intervals over the 16 week treatment period for wounds that do not show evidence of healing. For wounds that do show evidence of healing, additional applications of TTAX01 will be withheld, based on observations from retrospective case series.

Subjects whose wounds close prior to 16 weeks will move directly to a 2 week confirmation of closure period. Subjects whose wounds have not closed by the end of 16 weeks will exit the trial.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open Label Phase 2 Pilot Trial of Subjects With Complex Non-healing Diabetic Foot Ulcers Treated With Standard Care Plus Cryopreserved Umbilical Cord Allograft (TTAX01)
Actual Study Start Date : October 4, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TTAX01
TTAX01 will be applied directly to the wound surface and retained with non-absorbable sutures. A single layer of the test article should cover the entire open surface of the wound. The material is to be applied once every 4 weeks unless the wound shows evidence of healing, in which case dosing is suspended; or, if the test article has been accidentally dislodged, it may be replaced at any time.
Biological: TTAX01
TTAX01 will be applied directly to the wound surface and retained with non-absorbable sutures. A single layer of the test article should cover the entire open surface of the wound. The material is to be applied once every 4 weeks unless the wound shows evidence of healing, in which case dosing is suspended; or, if the test article has been accidentally dislodged, it may be replaced at any time.




Primary Outcome Measures :
  1. Complete wound healing [ Time Frame: 16-weeks ]
    Proportion of subjects with complete wound healing observed over the 16-week treatment period


Secondary Outcome Measures :
  1. Time to complete wound healing [ Time Frame: up to 16 weeks ]
    Time in number of days to complete wound closure over the 16 week treatment period, starting from enrollment to the time of the initial observation of wound closure

  2. Complete wound healing [ Time Frame: up to 16 weeks ]
    Proportion of subjects with complete wound closure at each of the 16 treatment weeks

  3. Rate of wound closure (area) [ Time Frame: up to 16 weeks ]
    Percent change in the wound surface area (cm2) at each visit from baseline for assessing the rate of wound closure in area

  4. Rate of wound closure (volume) [ Time Frame: up to 16 weeks ]
    Percent change in the wound volume (cm3) at each visit from baseline for assessing the rate of wound closure in volume

  5. Rate of wound closure (depth) [ Time Frame: up to 16 weeks ]
    Percent change in the wound depth (cm) at each visit from baseline for assessing the rate of wound closure in depth

  6. Rate of wound closure (granulation tissue) [ Time Frame: up to 16 weeks ]
    Percent of index wound covered by the granulation tissue at each visit for assessing the rate of wound closure in granulation tissue

  7. To examine additional efficacy endpoints related to wound healing [ Time Frame: up to 16 weeks ]
    Proportion of subjects achieving complete wound closure in subjects with pathologically confirmed osteomyelitis

  8. Incidence of ulcer-related complications [ Time Frame: 21 weeks ]
    Proportion of subjects who experience ulcer-related complications (e.g., life-threatening, infection-related sepsis complications, recurrent osteomyelitis, development of gangrene)

  9. To examine the effect of therapy on ulcer-related complications [ Time Frame: 21 weeks ]
    Proportion of subjects who experience limb amputation (i.e., full amputation involving the index ulcer anatomic location) among subjects with and without pathologically confirmed osteomyelitis

  10. To examine the effect of therapy on ulcer-related complications [ Time Frame: 21 weeks ]
    Time in number of days to the first amputation on the target limb or foot or death, whichever occurs first



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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, 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 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03230175


Locations
United States, Arizona
Banner University Medical Center
Phoenix, Arizona, United States, 85006
United States, California
UCLA Olive View
Sylmar, California, United States, 91342
United States, Florida
University of Miami
Miami, Florida, United States, 33125
United States, Georgia
Village Podiatry Centers
Smyrna, Georgia, United States, 30082
United States, Illinois
Rosalind Franklin University
North Chicago, Illinois, United States, 60064
United States, Louisiana
Ochsner Medical Center
New Orleans, Louisiana, United States, 70121
United States, New York
St Luke's-Roosevelt Hospital Center
New York, New York, United States, 10025
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
United States, Texas
Futuro Clinical Trials, LLC
McAllen, Texas, United States, 78501
United States, Virginia
Carilion Clinic
Roanoke, Virginia, United States, 24013
Sponsors and Collaborators
Tissue Tech Inc.
Investigators
Study Chair: Scheffer Tseng, MD Chief Technology Officer

Responsible Party: Tissue Tech Inc.
ClinicalTrials.gov Identifier: NCT03230175     History of Changes
Other Study ID Numbers: TTCRNE-1501
First Posted: July 26, 2017    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Ulcer
Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases