Trials / Unknown
UnknownNCT05274295
Open Label Single Arm Proof of Concept Trial to Evaluate the Efficacy and Safety of Cytori Celution System in Diabetic Leg Ulcers
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 5 (estimated)
- Sponsor
- Szeged University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the efficacy and safety of Cytori Celution System in Hungarian patients with diabetic leg ulcers.
Detailed 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.
Conditions
- Diabetic Foot Ulcer
- Leg Ulcer
- Autologous Adipose Stromal Vascular Fraction
- Mesenchymal Stem Cells
- Adipose-Derived Mesenchymal Stem Cells
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Diabetic leg ulcer treatment with adipous SVF | 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. |
Timeline
- Start date
- 2022-02-28
- Primary completion
- 2022-04-30
- Completion
- 2022-04-30
- First posted
- 2022-03-10
- Last updated
- 2022-05-03
Locations
1 site across 1 country: Hungary
Source: ClinicalTrials.gov record NCT05274295. Inclusion in this directory is not an endorsement.