Umbilical Cord Patch (TTAX01) for Diabetic Foot Ulcers

Recruiting at 19 trial locations

Overseen By Stanley Harris

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: BioTissue Holdings, Inc

Must not be taking: Oral steroids, Parenteral corticosteroids

Disqualifiers: Major amputation, Cancer, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

106 Participants Needed

Trial Summary

What is the purpose of this trial?

It is hypothesized that application at 4-week or greater intervals of the human placental umbilical cord tissue TTAX01 to the surface of a well debrided, complex diabetic foot ulcer (DFU) will, with concomitant management of infection, result in a higher rate of wounds showing complete healing within 25 weeks of initiating therapy, compared with standard care alone. This second confirmatory Phase 3 study examines a population of diabetic foot ulcer patients having adequate perfusion, with or without neuropathy, and a high suspicion of associated osteomyelitis in a complex, high grade wound.

Research Team

Seema Kumbhat, MD

Principal Investigator

Chief Medical Officer

Eligibility Criteria

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.

Inclusion Criteria

The subject has signed the informed consent form

The subject is willing to return for all mandatory visits as defined in the protocol

My foot ulcer is on the bottom or side of my foot.

Exclusion Criteria

The ulcer is on a foot that has a recent Charcot deformity.

You are allergic to glycerol.

I cannot avoid putting weight on a certain part of my body as required.

Treatment Details

Interventions

• TTAX01

Trial Overview 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.

Participant Groups

Group I: TTAX01 Experimental Treatment 2 Interventions

TTAX01 plus standard of care

Group II: Control Experimental Treatment 1 Intervention

Standard care alone

Who Is Running the Clinical Trial?

BioTissue Holdings, Inc

Lead Sponsor

Trials

17

Recruited

970+

Tissue Tech Inc.

Lead Sponsor

Trials

16

Recruited

900+