NCT02657876

ExpressGraft-C9T1 Skin Tissue as a Treatment of Diabetic Foot Ulcers

An Open-Label, Prospective, Safety, and Tolerability Study of ExpressGraft-C9T1 Skin Tissue in the Treatment of Diabetic Foot Ulcers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Stratatech, a Mallinckrodt Company · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is designed as a prospective, open-label trial focused on assessing the safety and tolerability of ExpressGraft-C9T1 skin tissue in the treatment of diabetic foot ulcers (DFU). Because the focus is on safety rather than efficacy, a standard of care comparator is not included in this first-in-human study. Targeted enrollment for this study is up to 6 subjects with a confirmed diagnosis of diabetes and who have foot ulcers. Subjects will each receive a single application of ExpressGraft-C9T1 skin tissue on a single identified study DFU following a 10-14 day run-in period. Any subjects requiring additional treatment will receive protocol-defined dressings through Study Treatment Week 12 as necessary. Enrollment will occur with a minimum of one week between each subject.

Conditions

• Diabetes
• Diabetic Foot Ulcer
• Non-healing Wound

Interventions

Type	Name	Description
BIOLOGICAL	ExpressGraft-C9T1 Skin Tissue	ExpressGraft-C9T1 skin tissue is provided as a suturable, biologically-active, circular skin tissue with a fully-stratified epithelial compartment comprised of human keratinocytes (NIKSC9T1) and a dermal compartment containing fibroblasts

Timeline

• Start date: 2018-01-31
• Primary completion: 2019-05-28
• Completion: 2019-05-28
• First posted: 2016-01-18
• Last updated: 2019-10-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study