DiabetesPhase 1NCT02657876
ExpressGraft-C9T1 Skin Tissue as a Treatment of Diabetic Foot Ulcers
A Phase 1 study testing ExpressGraft-C9T1 Skin Tissue in people with Diabetes and Diabetic Foot Ulcer, run by Stratatech, a Mallinckrodt Company at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes, Diabetic Foot Ulcer, Non-healing Wound
- What is being tested?
- ExpressGraft-C9T1 Skin Tissue
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2018to 28 May 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
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- 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.
- History of toe amputation in either leg would not be exclusionary.
- Patients with history of poor compliance
- Patients with baseline panel reactive antibody (PRA) of ≥ 20%
- MEDICATIONS/THERAPIES
- Oral or parenteral corticosteroids, immunosuppressants, radiation therapy or chemotherapy within 30 days prior to study enrollment
- Use of an investigational product within the preceding 60 days
- STUDY ULCER
- Signs and symptoms of clinical infection at study ulcer site
- Study ulcer requiring antimicrobial therapy at Screening Visit or Study Treatment Day 0 due to clinical suspicion of infection
- Treatment of study ulcer with Regranex® or hyperbaric oxygen within preceding 30 days
- Previous treatment of study ulcer with any cell and/or tissue product (CTP) therapy
- Change in wound size (increase/decrease) greater than 25% from Screening Visit to Study Treatment Day 0
- Other ulcers within 3 cm of study ulcer
- Ulcers with tendon, muscle, joint capsule, or bone exposure
Trial locations and contacts
1 site in 1 country.
United States1 site
SerenaGroup Research Institute
Pittsburgh, Pennsylvania, 15222
About this study
Official title: An Open-Label, Prospective, Safety, and Tolerability Study of ExpressGraft-C9T1 Skin Tissue in the Treatment of Diabetic Foot Ulcers
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
- Being tested
- ExpressGraft-C9T1 Skin Tissue
- Medical subject headings
- Diabetes Mellitus, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| ExpressGraft-C9T1 Skin Tissue | Experimental | Enrolled participants receive one application of ExpressGraft-C9T1 skin tissue Receives: Biological: ExpressGraft-C9T1 Skin Tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, at approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2016 (estimated)
- Study start31 Jan 2018
- Primary completion28 May 2019
- Study completion28 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stratatech, a Mallinckrodt Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Leader, Study director, Mallinckrodt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02657876
- Sponsor's protocol ID
- C9T12015
- Other IDs
- R44DK069924-08
- Status last verified
- Oct 2019
- First submitted
- 6 Jan 2016
- Last updated
- 15 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Prospective, Safety, and Tolerability Study of ExpressGraft-C9T1 Skin Tissue in the Treatment of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT02657876
- Acronym / sponsor ID
- C9T12015
- Conditions
- Diabetes, Diabetic Foot Ulcer, Non-healing Wound
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Stratatech, a Mallinckrodt CompanyIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 28 May 2019 (actual)
- Study completion
- 28 May 2019 (actual)
- First posted
- 18 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ExpressGraft-C9T1 Skin Tissue | Experimental | Biological: ExpressGraft-C9T1 Skin TissueEnrolled participants receive one application of ExpressGraft-C9T1 skin tissue |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExpressGraft-C9T1 Skin TissueExpressGraft-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 | Biological | ExpressGraft-C9T1 Skin Tissue |
Primary outcome
Number of participants with adverse events through study completion
Time frame: Through study completion, at approximately 12 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Leader study director
Mallinckrodt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ExpressGraft-C9T1 Skin Tissue in people with Diabetes and Diabetic Foot Ulcer, run by Stratatech, a Mallinckrodt Company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events through study completion (time frame: Through study completion, at approximately 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2019.