NCT02657876

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1 diabetes

Timeline
Completed

Started Jan 2018

Longer than P75 for phase_1 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 18, 2016

Completed
2 years until next milestone

Study Start

First participant enrolled

January 31, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2019

Completed
Last Updated

October 15, 2019

Status Verified

October 1, 2019

Enrollment Period

1.3 years

First QC Date

January 6, 2016

Last Update Submit

October 11, 2019

Conditions

DiabetesDiabetic Foot UlcerNon-healing Wound

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse events through study completion

    Clinically significant vital signs, infection, blood chemistry, hematology and immunological evaluations are recorded as adverse events during the study. The safety of ExpressGraft-C9T1 skin tissue will be evaluated by adverse events through the 12 month study session.

    Through study completion, at approximately 12 months

Study Arms (1)

ExpressGraft-C9T1 Skin Tissue

EXPERIMENTAL

Enrolled participants receive one application of ExpressGraft-C9T1 skin tissue

Biological: ExpressGraft-C9T1 Skin Tissue

Interventions

ExpressGraft-C9T1 Skin TissueBIOLOGICAL

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

ExpressGraft-C9T1 Skin Tissue

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • MEDICAL HISTORY/CURRENT MEDICAL CONDITION
  • Pregnant or nursing women
  • Prisoners
  • Abnormal laboratory value(s) for routine blood work that the Clinical Investigator deems would not be in the subject's best interest to participate
  • Osteomyelitis in the study ulcer foot in the last 30 days
  • Grade 3 or 4 lower extremity edema
  • Unable to tolerate off-loading
  • Active Charcot's foot
  • History of malignancy in previous 5 years, except for basal cell carcinoma that has been treated with local excision and is no longer present
  • Patients with unstable chronic renal disease or requiring dialysis
  • Gangrene in any part of study ulcer foot
  • Patients with a history of above- or below-knee amputation in the contralateral leg related to underlying chronic disease.
  • Patients with history of poor compliance
  • Patients with baseline panel reactive antibody (PRA) of ≥ 20%
  • MEDICATIONS/THERAPIES
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SerenaGroup Research Institute

Pittsburgh, Pennsylvania, 15222, United States

Location

MeSH Terms

Conditions

Diabetes MellitusDiabetic Foot

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetic Neuropathies

Study Officials

  • Global Clinical Leader

    Mallinckrodt

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2016

First Posted

January 18, 2016

Study Start

January 31, 2018

Primary Completion

May 28, 2019

Study Completion

May 28, 2019

Last Updated

October 15, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)