Subjects With Non-Healing Venous Leg Ulcers Treated With Standard Care Plus Cryopreserved Human Umbilical Cord (TTAX01)
Public ClinicalTrials.gov record NCT03818828. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Open Label Phase 2 Pilot Trial of Subjects With Non-Healing Venous Leg Ulcers Treated With Standard Care Plus Cryopreserved Human Umbilical Cord (TTAX01)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT03818828
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 31 participants
Conditions and interventions
Conditions
Interventions
- TTAX01 Biological
- Profore Compression Therapy Other
- Cadexomer Iodine dressing Other
Biological · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 14, 2019 (Actual)
- Primary completion
- Dec 20, 2019 (Actual)
- Completion
- Jan 28, 2020 (Actual)
- Last update posted
- Sep 3, 2020
2019 – 2020
United States locations
- U.S. sites
- 6
- U.S. states
- 5
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| ILD Consulting, Inc. | Carlsbad | California | 92009 | — |
| UCLA Olive View | Sylmar | California | 91342 | — |
| Rosalind Franklin University | North Chicago | Illinois | 60064 | — |
| Advanced Foot & Ankle Center | Las Vegas | Nevada | 89119 | — |
| St Luke's-Roosevelt Hospital Center | New York | New York | 10025 | — |
| Carilion Clinic | Roanoke | Virginia | 24013 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03818828, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 3, 2020 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03818828 live on ClinicalTrials.gov.