Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Stratatech, a Mallinckrodt Company
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Volunteers will be consented. Then there will be a run-in period for the doctor to run some tests. If the tests show the study would be good for the patient, the doctor will enroll them as participants in the trial.
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
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
You may not be if
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
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
Clareo Health | Multiple Applications of ExpressGraft-C9T1 Skin Tissue as a Treatment for Diabetic Foot Ulcers
