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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)

Primary Purpose

Non-healing Wound, Non-healing Diabetic Foot Ulcer, Diabetic Foot Infection

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TTAX01
Surgical resection and debridement
Systemic antibiotics
Off-loading
Sponsored by
Tissue Tech Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-healing Wound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Banner University Medical Center
  • UCLA Olive View
  • University of Miami
  • Village Podiatry Centers
  • Rosalind Franklin University
  • Ochsner Medical Center
  • St Luke's-Roosevelt Hospital Center
  • University of North Carolina
  • Vanderbilt University Medical Center
  • Futuro Clinical Trials, LLC
  • Carilion Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TTAX01 plus standard care

Arm Description

Eligible consenting subjects will undergo a baseline aggressive debridement in the operating room to remove infected and devitalized bone and soft tissue. A six week course of systemic antibiotics will be used to resolve baseline infection. 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.

Outcomes

Primary Outcome Measures

Number of Subjects With Complete Wound Healing
Proportion of subjects with complete wound healing observed over the 16-week treatment period. Complete wound healing was defined as an initial observation of closure, followed by two confirmatory visits two weeks apart.

Secondary Outcome Measures

Time to Complete Wound Healing
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
Percent Change in Wound Surface Area
Rate of wound closure, specifically percent change in the wound surface area (cm2) at each visit from baseline for assessing the rate of wound closure in area. Only percent change in wound surface area at week 16 reported.

Full Information

First Posted
July 19, 2017
Last Updated
May 20, 2021
Sponsor
Tissue Tech Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03230175
Brief Title
Phase 2 Pilot Trial of Subjects With Complex Non-healing Diabetic Foot Ulcers Treated With Standard Care Plus Cryopreserved Umbilical Cord Allograft (TTAX01)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
October 4, 2017 (Actual)
Primary Completion Date
January 10, 2019 (Actual)
Study Completion Date
April 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tissue Tech Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-healing Wound, Non-healing Diabetic Foot Ulcer, Diabetic Foot Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TTAX01 plus standard care
Arm Type
Experimental
Arm Description
Eligible consenting subjects will undergo a baseline aggressive debridement in the operating room to remove infected and devitalized bone and soft tissue. A six week course of systemic antibiotics will be used to resolve baseline infection. 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.
Intervention Type
Biological
Intervention Name(s)
TTAX01
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Surgical resection and debridement
Intervention Description
Perform surgical sharp debridement in the OR, to remove: infectious agents and biofilms (purulence), all debris, eschar, callus and macerated non-viable tissue from the wound base, and dead (suprabasal epidermis), scarred (elevated/edematous) and necrotic/macerated tissue from the wound edge. Surgical Resection will be performed to remove as much of the necrotic bone detected by the radiographic evidence as is appropriate.
Intervention Type
Drug
Intervention Name(s)
Systemic antibiotics
Intervention Description
Six (6) weeks of systemic antibiotic therapy is required. A definitive therapy will be guided by the microbiological results based on bone biopsy.
Intervention Type
Device
Intervention Name(s)
Off-loading
Intervention Description
Provide off-loading device appropriate to the location of wound with full length boot or total contact cast
Primary Outcome Measure Information:
Title
Number of Subjects With Complete Wound Healing
Description
Proportion of subjects with complete wound healing observed over the 16-week treatment period. Complete wound healing was defined as an initial observation of closure, followed by two confirmatory visits two weeks apart.
Time Frame
16-weeks
Secondary Outcome Measure Information:
Title
Time to Complete Wound Healing
Description
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
Time Frame
up to 16 weeks
Title
Percent Change in Wound Surface Area
Description
Rate of wound closure, specifically percent change in the wound surface area (cm2) at each visit from baseline for assessing the rate of wound closure in area. Only percent change in wound surface area at week 16 reported.
Time Frame
at week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scheffer Tseng, MD
Organizational Affiliation
Chief Technology Officer
Official's Role
Study Chair
Facility Information:
Facility Name
Banner University Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
UCLA Olive View
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Village Podiatry Centers
City
Smyrna
State/Province
Georgia
ZIP/Postal Code
30082
Country
United States
Facility Name
Rosalind Franklin University
City
North Chicago
State/Province
Illinois
ZIP/Postal Code
60064
Country
United States
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
St Luke's-Roosevelt Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Futuro Clinical Trials, LLC
City
McAllen
State/Province
Texas
ZIP/Postal Code
78501
Country
United States
Facility Name
Carilion Clinic
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24013
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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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