It is hypothesized that application at 4-week intervals of the human umbilical cord tissue TTAX01 to the surface of a well debrided, nonhealing venous leg ulcer (VLU) will result in a high proportion of wounds showing complete healing within 12 weeks of initiating therapy. This open label pilot study provides a framework for a larger, controlled study. The purposes for conducting this study are to evaluate the functionality of the protocol and to obtain an estimate of product safety and efficacy when applied according to the protocol instructions, and measured according to the stated endpoints.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
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 Dulbecco's Modified Eagle Medium/Glycerol (1:1) containing Amphotericin B.
Subjects will utilize the compression system for the duration of the trial, with weekly re-applications of the compression system during study visits
During the 2-week Screening Run-in period, subjects should be applied cadexomer iodine on the VLU.
ILD Consulting, Inc.
Carlsbad, California, United States
UCLA Olive View
Sylmar, California, United States
Rosalind Franklin University
North Chicago, Illinois, United States
Advanced Foot & Ankle Center
Las Vegas, Nevada, United States
St Luke's-Roosevelt Hospital Center
New York, New York, United States
Carilion Clinic
Roanoke, Virginia, United States
Complete wound healing
Proportion of subjects who achieve complete wound closure over the 12-week treatment period from baseline with a 4 week followup to confirm wound healing.
Time frame: 12-weeks
Time to complete wound healing
Time, in days, from baseline to initial observation of closure, in cases where healing is later confirmed.
Time frame: up to 12 weeks
Complete wound healing
Proportion of subjects with complete wound closure at each of the 12 treatment weeks from baseline
Time frame: up to 12 weeks
Changes in pain using the numeric rating scale
Change from baseline in pain level as reported using a numeric rating scale for the target ulcer and the affected leg, separately. Subjects will be asked to rate the level of pain they experience on a scale from 0 to 10, with 0 representing "no pain" and 10 representing "the worst possible pain".
Time frame: up to 12 weeks
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