Completed PHASE3 INTERVENTIONAL 2-arm NCT04450693

Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU II)

A Multicenter Phase 3 Confirmatory Trial of Biotherapy Using Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU II)

Sponsor: BioTissue Holdings, Inc

Conditions Diabetic Foot Infection Non-healing Diabetic Foot Ulcer Non-healing Wound

Interventions Standard care TTAX01

Updated 21 times since 2020 Last updated: Mar 26, 2025 Started: Nov 20, 2020 Primary completion: Mar 24, 2025 Completion: Mar 24, 2025

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Diabetic Foot Infection and Non-healing Diabetic Foot Ulcer, this trial is completed. The trial is conducted by BioTissue Holdings, Inc and has accumulated 21 data snapshots since 2020. Infectious disease trials contribute critical data for public health response and treatment development.

Status Flow

Change History

21 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
May 2025 — Sep 2025 [monthly]

Completed PHASE3

Status: Active Not Recruiting → Completed
Feb 2025 — May 2025 [monthly]

Active Not Recruiting PHASE3

Status: Recruiting → Active Not Recruiting
Oct 2024 — Feb 2025 [monthly]

Recruiting PHASE3
Sep 2024 — Oct 2024 [monthly]

Recruiting PHASE3

▶ Show 16 earlier versions

Jul 2024 — Sep 2024 [monthly]

Recruiting PHASE3
Jan 2024 — Jul 2024 [monthly]

Recruiting PHASE3
Dec 2023 — Jan 2024 [monthly]

Recruiting PHASE3
Oct 2023 — Dec 2023 [monthly]

Recruiting PHASE3
Feb 2023 — Oct 2023 [monthly]

Recruiting PHASE3
Nov 2022 — Feb 2023 [monthly]

Recruiting PHASE3
Nov 2021 — Nov 2022 [monthly]

Recruiting PHASE3
Oct 2021 — Nov 2021 [monthly]

Recruiting PHASE3
Sep 2021 — Oct 2021 [monthly]

Recruiting PHASE3
Jun 2021 — Sep 2021 [monthly]

Recruiting PHASE3
May 2021 — Jun 2021 [monthly]

Recruiting PHASE3
Apr 2021 — May 2021 [monthly]

Recruiting PHASE3
Mar 2021 — Apr 2021 [monthly]

Recruiting PHASE3
Jan 2021 — Mar 2021 [monthly]

Recruiting PHASE3
Dec 2020 — Jan 2021 [monthly]

Recruiting PHASE3

Status: Not Yet Recruiting → Recruiting
Jul 2020 — Dec 2020 [monthly]

Not Yet Recruiting PHASE3

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

BioTissue Holdings, Inc

Data source: BioTissue Holdings, Inc

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Boston, United States , Circleville, United States , Dallas, United States , DeLand, United States , Delray Beach, United States , Guntersville, United States , Houston, United States , Los Angeles, United States , Mather, United States , O'Fallon, United States and 5 more locations