← Back to Search

Tissue Therapy

Umbilical Cord Patch (TTAX01) for Diabetic Foot Ulcers

Verified Trial
Phase 3
Recruiting
Research Sponsored by Tissue Tech Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up by week 26
Awards & highlights

Study Summary

This trial is testing a new treatment for diabetic foot ulcers, comparing it to standard care. The new treatment is a patch made from human placental umbilical cord tissue, applied every 4 weeks. The trial will measure how many ulcers are completely healed within 25 weeks.

Who is the study for?
Adults with Type I or II diabetes and complex, non-healing diabetic foot ulcers suspected of osteomyelitis can join. They must have an ulcer ≤ 12.0 cm2 on certain parts of the foot, adequate blood flow to the area, and be willing to follow trial procedures. Excluded are those with recent cancer (except skin), very high HbA1c levels (>12%), specific medication use like Invokana™ or steroids, pregnant/nursing women, allergies related to the trial's materials, or severe infections.Check my eligibility
What is being tested?
The study is testing if TTAX01 (a human umbilical cord tissue) applied every four weeks helps heal serious diabetic foot ulcers better than standard care alone within 25 weeks. It includes patients who manage their diabetes well and might have bone infection due to the ulcer.See study design
What are the potential side effects?
Potential side effects aren't specified for TTAX01 but may include typical reactions to biological products such as local irritation at application site or allergic responses. Standard care side effects depend on treatments used which could range from infection control measures to wound management techniques.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~by week 26
This trial's timeline: 3 weeks for screening, Varies for treatment, and by week 26 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete wound healing
Secondary outcome measures
Limb preservation
Patient-reported mobility
Wound durability

Trial Design

2Treatment groups
Experimental Treatment
Group I: TTAX01Experimental Treatment2 Interventions
TTAX01 plus standard of care
Group II: ControlExperimental Treatment1 Intervention
Standard care alone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TTAX01
2019
Completed Phase 2
~70

Find a Location

Who is running the clinical trial?

Tissue Tech Inc.Lead Sponsor
15 Previous Clinical Trials
718 Total Patients Enrolled
Herbert Slade, MDStudy ChairChief Medical Officer
1 Previous Clinical Trials
220 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there a number of research sites in Canada running this experiment?

"There are many locations where this trial is available, such as Gateway Clinical Trials, LLC in O'Fallon, Boston Medical Center in Boston, NorthBay Healthcare in Fairfield."

Answered by AI

Are there still opportunities for people to join this research project?

"Yes, you are correct. The information on clinicaltrials.gov does say that this study is presently recruiting patients. The study was originally posted on 11/20/2020 and was last updated on 10/11/2022. The clinical trial is recruiting for 220 patients across 16 locations"

Answered by AI

What is the fatality rate of TTAX01?

"TTAX01 was given a safety score of 3 by our team at Power. This is because it has reached Phase 3 in clinical trials, meaning that there is some evidence supporting its efficacy as well as multiple rounds of data affirming its safety."

Answered by AI

How many people are included in the data sample for this research?

"The sponsor, Tissue Tech Inc., needs to enroll 220 patients that meet the study's inclusion criteria. This will be done at multiple medical sites, including Gateway Clinical Trials in O'Fallon, Illinois and Boston Medical Center."

Answered by AI

Who else is applying?

What state do they live in?
California
Texas
How old are they?
18 - 65
What site did they apply to?
VA Northern California Health Care System
Other
Curalta Foot and Ankle
Medicus Alliance Clinical Research
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I trying to find a solution to this problem. I’m in constant pain tried gabapentin, cymbalta and lyrica didn’t work so I stopped taking them.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU II)
2020. "Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU II)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04450693.
~20 spots leftby Sep 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top