Umbilical Cord Patch (TTAX01) for Diabetic Foot Ulcers

No longer 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: 4

Duration: 25 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special umbilical cord patch, TTAX01, can heal diabetic foot ulcers more effectively than standard care alone. The researchers aim to determine if applying this patch every four weeks, along with infection management, improves wound healing within 25 weeks. People with diabetes who have foot ulcers extending beyond the skin and showing signs of bone infection (osteomyelitis) might be suitable candidates for this trial. As a Phase 3 trial, this research represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Do I need to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking the type 2 diabetes medicine canagliflozin (Invokana™, Invokamet™, Invokamet XR™).

Is there any evidence suggesting that TTAX01 is likely to be safe for humans?

Research has shown that TTAX01 is generally safe for people with diabetic foot ulcers. One study found that TTAX01 led to fewer major amputations and improved healing rates, indicating that the treatment is usually well-tolerated. Long-term follow-up data confirm TTAX01's safety. Serious side effects are uncommon, making it a promising option for those considering joining the clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for diabetic foot ulcers?

Unlike the standard treatments for diabetic foot ulcers, which often include wound care, antibiotics, and sometimes surgery, TTAX01 is unique because it uses an umbilical cord patch to promote healing. This innovative patch is designed to harness the natural regenerative properties found in umbilical cord tissue, which may enhance tissue repair and reduce inflammation more effectively. Researchers are excited about TTAX01 because it has the potential to accelerate healing and improve outcomes for patients, offering a new approach that could work faster and more efficiently than existing options.

What evidence suggests that TTAX01 might be an effective treatment for diabetic foot ulcers?

Research has shown that TTAX01, a treatment derived from preserved human umbilical cord tissue, holds promise for healing diabetic foot ulcers (DFUs), particularly the more severe Wagner Grades 3 and 4. Studies have demonstrated that this treatment leads to higher healing rates and fewer amputations compared to other therapies. Specifically, one study found a significant improvement in healing rates at 16 weeks for patients with severe DFUs. In this trial, participants will receive either TTAX01 plus standard care or standard care alone. TTAX01 provides essential growth factors and cells that aid in repairing damaged tissue, making it potentially effective for treating complex diabetic foot wounds. ^{1 2 4 6 7}

Who Is on the Research Team?

Seema Kumbhat, MD

Principal Investigator

Chief Medical Officer

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Application of TTAX01 to diabetic foot ulcers at intervals of 4 weeks or greater, with concomitant management of infection

25 weeks

Visits every 4 weeks for TTAX01 application

Follow-up

Participants are monitored for wound healing, re-ulceration, and limb preservation

1 week

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6900178/

An open‐label trial of cryopreserved human umbilical cord in ... Among 6,498 matching records in patients with diabetic Wagner 3 or 4 ulcers, the healing rate at 16 weeks was 34.7% using all available therapies. Thus, the ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04450693

Cryopreserved Human Umbilical Cord (TTAX01) for Late ... This trial is designed as a confirmatory study of the benefits and risks of TTAX01 when used in the treatment of Wagner Grades 3 and 4 DFU. Experience with the ...

3. ohsu.edu ohsu.edu/sites/default/files/2021-04/TTAX01-CR003%20Protocol%20final%20v1.1%2030Oct2019.pdf

CLINICAL RESEARCH PROTOCOL A single-centre, retrospective study of cryopreserved umbilical cord/amniotic membrane tissue for the treatment of diabetic foot ulcers. J ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32386343/

One-year safety, healing and amputation rates of Wagner 3 ... One-year safety, healing and amputation rates of Wagner 3-4 diabetic foot ulcers treated with cryopreserved umbilical cord (TTAX01). Wound Repair Regen. 2020 ...

5. cms.gov cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39763&ver=8

Proposed LCD - Skin Substitute Grafts/Cellular and Tissue ... This LCD covers skin substitute grafts/cellular and tissue-based products (CTP) for the treatment of diabetic foot ulcers (DFU) and venous leg ulcers (VLU) in ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04450693?term=CETRIMIDE&viewType=Table&rank=8

Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, ... A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02844660

Dehydrated Human Umbilical Cord Allograft in the ... Index ulcer determined to be due to active Charcot deformity or major structural abnormalities of the foot; Exhibits clinical signs and symptoms of infection ...