DiabetesPhase 1NCT04134143
Multiple Applications of ExpressGraft-C9T1 Skin Tissue as a Treatment for 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 4 sites in United States.
Trial summary
Some people with diabetes get foot ulcers that do not heal. These ulcers can get infected and cause other medical problems. Five patients with these foot ulcers volunteered to participate in the first part of this study (C9T12015, NCT02657876). They are called Cohort 1 in this registration. 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
- 6 participants
- Where
- 4 sitesUnited States
- Study dates
- 7 Nov 2019to 30 Dec 2020
- 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
- To be considered for inclusion, a participant:
- Agrees to practice birth control for the duration of the study
- Has documented Type 1 or Type 2 diabetes and an HbA1C score of 10 or below
- Has protocol-defined sufficient blood pressure and flow to the foot
- Has stable medications for 2 weeks before treatment (other than diabetes medications or antibiotics)
- Is able and willing to attend scheduled visits and comply with study procedures
Show all 9Show fewer
- If a smoker, agrees to try quitting and will accept counseling for it (Cohorts 2 and 3 only)
- Has documented informed consent for study enrollment
- Has had an uninfected, appropriately-sized diabetic ulcer on the foot for at least 4 weeks but not more than 1 year
Who cannot join
- The doctor may not consider for inclusion a participant who:
- Is pregnant, nursing, or a prisoner
- Has had osteomyelitis in the foot with the ulcer in the last 30 days
- Has a history of poor compliance
- Has received drugs or therapies not allowed per protocol
- Has used an investigational product within the last 60 days
Show all 9Show fewer
- Has ever received therapy for the study ulcer with any cell and/or tissue product (CTP)
- Has a study ulcer in a condition not appropriate for the study
- Has a medical condition or history that, per protocol or in the opinion of the study doctor, might put the safety of the participant in danger
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Limb Preservation Platform, Inc.
Fresno, California, 93710
Center for Advanced Research & Education
Gainesville, Georgia, 30501
Titan Clinical Research
Phoenix, Arizona, 85004
Center For Clinical Resarch
San Francisco, California, 94115
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
Some people with diabetes get foot ulcers that do not heal. These ulcers can get infected and cause other medical problems.
Five patients with these foot ulcers volunteered to participate in the first part of this study (C9T12015, NCT02657876). They are called Cohort 1 in this registration. Cohort 1 received one application (piece) of an experimental skin tissue to make sure it was safe.
Read more
This study will extend the safety test of the experimental skin tissue. It will find out if it is safe to use more than once to cover non-healing ulcers.
This extension will include two more groups, Cohort 2 and Cohort 3. Cohort 2 may get up to 5 applications. Cohort 3 may get up to 10 applications. The number of applications will depend on how well the wound is healing.
Participants will be in the study up to one year.
- 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
Also called Experimental skin tissue
A round patch of experimental skin tissue that the doctor applies over the ulcer
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: One Application | Experimental | Participants enrolled in Cohort 1 received one application of experimental skin tissue during the first part of this trial (NCT02657876) Receives: Biological: ExpressGraft-C9T1 Skin Tissue |
| Cohort 2: Up to Five Applications | Experimental | Participants enrolled in Cohort 2 may receive up to 5 applications of experimental skin tissue as required for wound healing Receives: Biological: ExpressGraft-C9T1 Skin Tissue |
| Cohort 3: Up to Ten Applications | Experimental | Participants enrolled in Cohort 3 may receive up to 10 applications of experimental skin tissue as required for wound healing 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 at Week 12
Clinically significant vital signs, infection, blood chemistry, hematology and immunological evaluations are recorded as adverse events
Measured: at Week 12
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
Measured: 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 posted22 Oct 2019
- Study start7 Nov 2019
- Primary completion25 Nov 2020
- Study completion30 Dec 2020
Why it stopped: Business decision - not related to product quality or safety concerns
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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Cohort 2 will begin when the study starts, and after the safety monitoring board approves progression to the next cohort, Cohort 3 will begin.
- Masking
- None (open label)
- Enrolment
- 6 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, Stratatech, a Mallinckrodt Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04134143
- Sponsor's protocol ID
- C9T12015 (Extended)
- Status last verified
- Jan 2021
- First submitted
- 18 Oct 2019
- Last updated
- 14 Jan 2021
- 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 14 Jan 2021. 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
- NCT04134143
- Acronym / sponsor ID
- C9T12015 (Extended)
- Conditions
- Diabetes, Diabetic Foot Ulcer, Non-healing Wound
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision - not related to product quality or safety concerns
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Stratatech, a Mallinckrodt CompanyIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2019 (actual)
- Primary completion
- 25 Nov 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 22 Oct 2019 (actual)
- 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.
Some people with diabetes get foot ulcers that do not heal. These ulcers can get infected and cause other medical problems.
Five patients with these foot ulcers volunteered to participate in the first part of this study (C9T12015, NCT02657876). They are called Cohort 1 in this registration. Cohort 1 received one application (piece) of an experimental skin tissue to make sure it was safe.
This study will extend the safety test of the experimental skin tissue. It will find out if it is safe to use more than once to cover non-healing ulcers.
This extension will include two more groups, Cohort 2 and Cohort 3. Cohort 2 may get up to 5 applications. Cohort 3 may get up to 10 applications. The number of applications will depend on how well the wound is healing.
Participants will be in the study up to one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Cohort 2 will begin when the study starts, and after the safety monitoring board approves progression to the next cohort, Cohort 3 will begin.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: One Application | Experimental | Biological: ExpressGraft-C9T1 Skin TissueParticipants enrolled in Cohort 1 received one application of experimental skin tissue during the first part of this trial (NCT02657876) |
| Cohort 2: Up to Five Applications | Experimental | Biological: ExpressGraft-C9T1 Skin TissueParticipants enrolled in Cohort 2 may receive up to 5 applications of experimental skin tissue as required for wound healing |
| Cohort 3: Up to Ten Applications | Experimental | Biological: ExpressGraft-C9T1 Skin TissueParticipants enrolled in Cohort 3 may receive up to 10 applications of experimental skin tissue as required for wound healing |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Agrees to practice birth control for the duration of the study
- Has documented Type 1 or Type 2 diabetes and an HbA1C score of 10 or below
- Has protocol-defined sufficient blood pressure and flow to the foot
- Has stable medications for 2 weeks before treatment (other than diabetes medications or antibiotics)
- Is able and willing to attend scheduled visits and comply with study procedures
Key exclusion criteria (9 listed)
- Is pregnant, nursing, or a prisoner
- Has had osteomyelitis in the foot with the ulcer in the last 30 days
- Has a history of poor compliance
- Has received drugs or therapies not allowed per protocol
- Has used an investigational product within the last 60 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 TissueAlso: Experimental skin tissueA round patch of experimental skin tissue that the doctor applies over the ulcer | Biological | Cohort 1: One Application, Cohort 2: Up to Five Applications, Cohort 3: Up to Ten Applications |
Primary outcome
Number of participants with adverse events at Week 12
Time frame: at Week 12
Clinically significant vital signs, infection, blood chemistry, hematology and immunological evaluations are recorded as adverse events
Number of participants with adverse events through study completion
Time frame: at approximately 12 months
Clinically significant vital signs, infection, blood chemistry, hematology and immunological evaluations are recorded as adverse events
Results and safety
The study was stopped early (reason given: Business decision - not related to product quality or safety concerns). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- 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
Stratatech, a Mallinckrodt Company
4 sites 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 4 sites 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 9 inclusion and 9 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: stopped early, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 was stopped early (reason given: Business decision - not related to product quality or safety concerns). Results are not available in the source record.
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 at Week 12 (time frame: at Week 12). The study lists 2 primary outcomes in all. 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 14 Jan 2021.