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

NCT02657876 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2019-10-15

No results posted yet for this study

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

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

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Stratatech, a Mallinckrodt Company

    lead INDUSTRY

Principal Investigators

  • Global Clinical Leader · Mallinckrodt

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-31
Primary Completion
2019-05-28
Completion
2019-05-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02657876 on ClinicalTrials.gov