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

Diabetic Foot Infection Clinical Trial

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

Status Completed

Clinical Trial Summary

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, will result in a higher rate of wounds showing complete healing within 26 weeks of initiating therapy, compared with standard care alone. This 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.

Clinical Trial Description

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 use of a cryopreserved umbilical cord (UC) product in treating such wounds, both prior to this Investigational New Drug application (IND) and under this IND, has indicated that a frequency of application of no shorter than every 4 weeks is associated with better than expected outcomes. Although treatment cannot be blinded, a "standard care only" arm is included to control for the benefits of aggressive baseline debridement combined with aggressive (6 weeks systemic) antibiotics. Current treatment guidelines indicate that aggressive debridement plus 1-2 weeks of antibiotics, or, minor debridement plus 6 weeks of antibiotics, would produce equivalent outcomes, although the evidence is not strong. By utilizing both maximum debridement and maximum antimicrobial therapy, the standard care described in this protocol may result in healing rates somewhat superior to current standard practice.

The design of this confirmatory study is matched to the design of the Phase 2 efficacy study TTCRNE-1501, with the exception of extending the primary endpoint from 16 to 26 weeks, and utilizing a proportional risk analysis rather than a landmark analysis. This design consideration is based on analysis of previous studies, and a desire to fold data from every visit into the primary analysis, rather than generating an excessive number of secondary endpoints. ;

Related Conditions & MeSH terms

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

• NCT number: NCT04176120
• Study type: Interventional
• Source: Tissue Tech Inc.
• Status: Completed
• Phase: Phase 3
• Start date: July 1, 2020
• Completion date: June 12, 2024