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To evaluate the efficacy and safety of Cytori Celution System in Hungarian patients with diabetic leg ulcers.
Full description
This motive trial can help to establish rutine application of this internationaly widely used device at University of Szeged. The primary outcome is the reduction rate of the wound size. The treatment response will be calculated from wound size before and after treatment. Any AEs related to the study devide will be monitored.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
More than 20% change in surface area of target ulcer between screening and renrollment visit.
There is bone involvement in case of ulcer
Patient with a history of bleeding disorder
Therapy for anticoagulation
Patient receiving corticosteroids, immunosuppressive or cytotoxic agents, and all systemic agents that can affect wound repair
Patient with any treatment that might interfere with the assessment of the study treatment
Pregnant or likely to become pregnant or lactating women
Participation in any type of clinical investigation concurrently or in the last 6 months
Positive for HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) and syphilis (results within 1 month are acceptable)
Any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for the participation in the study.
Active cancer during chemotherapy or radiotherapy, or recent cancer, if the remission had place less than 5 years before joining the study (except basal cell skin cancer)
Patient currently undergoing dialysis for renal insufficiency (serum creatinine ≥2 mg/dL)
In the opinion of treating physician, patient not expected to survive beyond 30 days
Subjects with psychiatric conditions that are anticipated to result in protocol noncompliance
Uncontrolled chronic disease
Patient with history of severe alcohol or drug abuse
Lack of patient's cooperation
Use with blood thinners within 8 weeks of enrollment, patients treated with Acetylsalicil Acid (ASA) are allowed to be enrolled. For these patients ASA therapy has to be swiched to Low Molecular Weight Heparin (LMWH) at screening (after cardiology consultation) for one week. LMWH has to be skipped on enrollment visit and ASA has to be re-started as soon as possible after lipoaspiration performed.
Systemic treatments with a possible effect on ulcers within 4 weeks prior to enrollment with the following exceptions:
Primary purpose
Allocation
Interventional model
Masking
5 participants in 1 patient group
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Central trial contact
Balázs Bende
Data sourced from clinicaltrials.gov
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