To evaluate the efficacy and safety of Cytori Celution System in Hungarian patients with chronic non-healing venous leg ulcers.
This motive trial can help to establish routine application of this internationally 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 adverse events related to the study device will be monitored.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
10
The Celution® System isolates approximately maximum 30 million SVF cells per 100 mL of adipose tissue to be processed. Approximately 1-3 million cells per injection (total 8-30) will be administered locally, in the target ulcer.
University of Szeged Department of Dermatology and Allergology
Szeged, Hungary
RECRUITINGReduction rate of the wound size
The treatment response will be calculated from wound size before and after treatment.
Time frame: 28 days
Wound closure at Day 28
Percentage of patients achieving 50% wound closure at Day 28
Time frame: 28 days
Improvement of Quality of Life (QoL) - EQ-5D-5L
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Time frame: 28 days
Improvement Wound pain
Improvement Wound pain visual analogue scale (VAS)
Time frame: 28 days
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