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

> **NCT04450693** · PHASE3 · COMPLETED · sponsor: **BioTissue Holdings, Inc** · enrollment: 106 (actual)

## Conditions studied

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

## Interventions

- **BIOLOGICAL:** TTAX01
- **OTHER:** Standard care

## Key facts

- **NCT ID:** NCT04450693
- **Lead sponsor:** BioTissue Holdings, Inc
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2020-11-20
- **Primary completion:** 2025-03-24
- **Final completion:** 2025-03-24
- **Target enrollment:** 106 (ACTUAL)
- **Last updated:** 2025-04-01


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04450693

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04450693, "Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU II)". Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/clinical/NCT04450693. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*