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

NCT03230175 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: TTCRNE-1501
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 11

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  16-weeks

Secondary Outcomes (2)

• Time to Complete Wound Healing

  up to 16 weeks

• Percent Change in Wound Surface Area

  at week 16

Study Arms (1)

TTAX01 plus standard care

EXPERIMENTAL

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.

Biological: TTAX01; Procedure: Surgical resection and debridement; Drug: Systemic antibiotics; Device: Off-loading

Interventions

TTAX01 BIOLOGICAL

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.

TTAX01 plus standard care

Surgical resection and debridement PROCEDURE

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.

TTAX01 plus standard care

Systemic antibiotics DRUG

Six (6) weeks of systemic antibiotic therapy is required. A definitive therapy will be guided by the microbiological results based on bone biopsy.

TTAX01 plus standard care

Off-loading DEVICE

Provide off-loading device appropriate to the location of wound with full length boot or total contact cast

TTAX01 plus standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BioTissue Holdings, Inc: lead

Study Sites (11)

Banner University Medical Center

Phoenix, Arizona, 85006, United States

Location

UCLA Olive View

Sylmar, California, 91342, United States

Location

University of Miami

Miami, Florida, 33125, United States

Location

Village Podiatry Centers

Smyrna, Georgia, 30082, United States

Location

Rosalind Franklin University

North Chicago, Illinois, 60064, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

St Luke's-Roosevelt Hospital Center

New York, New York, 10025, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Futuro Clinical Trials, LLC

McAllen, Texas, 78501, United States

Location

Carilion Clinic

Roanoke, Virginia, 24013, United States

Location

MeSH Terms

Interventions

Debridement

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Limitations and Caveats

The one caveat is the lack of a control group. However, the study was designed to examine the safety and estimate the efficacy of TTAX01 plus standard care in achieving complete would closure of these complex non-healing diabetic foot ulcer with high risk factors.

Results Point of Contact

• Title: Nick McCoy, Vice President Clinical Operations
• Organization: TissueTech, Inc.

nmccoy@tissuetechinc.com

7867340023

Study Officials

• Scheffer Tseng, MD

  Chief Technology Officer

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2017
• First Posted: July 26, 2017
• Study Start: October 4, 2017
• Primary Completion: January 10, 2019
• Study Completion: April 1, 2019
• Last Updated: June 15, 2021
• Results First Posted: June 15, 2021

Record last verified: 2021-05

Locations

US (11)