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Tissue Therapy

Umbilical Cord Patch (TTAX01) for Diabetic Foot Ulcers

Verified Trial
Phase 3
Recruiting
Research Sponsored by BioTissue Holdings, 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
No Placebo-Only Group
Pivotal Trial

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.
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.
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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 3
~290

Find a Location

Who is running the clinical trial?

BioTissue Holdings, IncLead Sponsor
15 Previous Clinical Trials
718 Total Patients Enrolled
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
~43 spots leftby Dec 2025
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