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Tissue Therapy

Umbilical Cord Patch (TTAX01) for Diabetic Foot Ulcers

Phase 3
Waitlist Available
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 confirmed diagnosis of Type I or Type II diabetes
The subject's index ulcer extends beyond the dermis, into subcutaneous tissue with evidence of exposed bone, tendon, muscle and/or joint capsule
Timeline
Screening 3 weeks
Treatment Varies
Follow Up by week 50
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 26 weeks.

Who is the study for?
Adults over 18 with Type I or II diabetes and complex, non-healing diabetic foot ulcers suspected of having bone infection (osteomyelitis) can join. They must have adequate blood flow to the affected foot, not be on certain diabetes medications like canagliflozin, not pregnant or nursing, able to follow off-loading protocol, and without recent steroid or cytotoxic agent use.Check my eligibility
What is being tested?
The trial is testing if applying TTAX01—a human umbilical cord tissue—on a well-cleaned diabetic foot ulcer improves healing within 26 weeks compared to standard care alone. It's for patients with good blood flow in their feet who may also have neuropathy.See study design
What are the potential side effects?
Potential side effects are not detailed here but could include reactions related to skin application such as irritation at the site of treatment. Allergies to dressing materials used in the trial or glycerol could also pose risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Type I or Type II diabetes.
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My wound is deep, exposing bone or muscle.
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My foot ulcer is on the bottom, side, or between my toes.
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My blood flow in the legs is within a healthy range.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~by week 50
This trial's timeline: 3 weeks for screening, Varies for treatment, and by week 50 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Complete wound healing
Limb preservation
Patient-reported mobility
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: TTAX01Experimental Treatment2 Interventions
TTAX01 plus standard 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.

Could you give me a breakdown of the patients who have signed up for this clinical trial?

"The sponsor, Tissue Tech Inc., needs to recruit 220 eligible patients from different locations in order to run the study. Some of these participating centres include Paley Orthopedic & Spine Institute and UCLA Olive View."

Answered by AI

Has the FDA sanctioned Standard Care?

"Standard Care received a score of 3 on Power's safety scale."

Answered by AI

Who else is applying?

What site did they apply to?
JPS
Mount Sinai West
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU)
2020. "Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04176120.
~9 spots leftby Jul 2024
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