Open Label Single Arm Proof of Concept Trial to Evaluate the Efficacy and Safety of Cytori Celution System in Diabetic Leg Ulcers
Primary Purpose
Diabetic Foot Ulcer, Leg Ulcer, Autologous Adipose Stromal Vascular Fraction
Status
Recruiting
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
Diabetic leg ulcer treatment with adipous SVF
Sponsored by
About this trial
This is an interventional device feasibility trial for Diabetic Foot Ulcer focused on measuring Cytori Celution System
Eligibility Criteria
Inclusion Criteria:
- Written informed consent
- Males or females age ≥ 18
- At least one diabetic leg ulcer with the following condition 3.1. Ulcer is present beyond 2 months 3.2. Conservative treatment not leading to improvement 3.3. Wound size between ≥5 and ≤100 cm2
- Ability to safely undergo tissue harvest that is anticipated to yield >100mL of adipose tissue at a site that is free from infection and injury
- Patients diagnosed with diabetes mellitus
- Able and willing to work with the doctor, adhere to therapeutic prescriptions and appear on prescribed examinations
- Normal or clinically not significant abnormal values based on investigator judgement on white blood cell count (WBC), C-reactive protein (CRP), Platelets, international normalized ratiod (INR), partial thromboplastin time (APTT), haemoglobin (Hgb), Renal and Liver function
- Females of childbearing potential must have a negative pregnancy test at the Screen Visit
- Females of childbearing potential must agree to use a highly effective method of birth control during the study. A highly effective method of birth control is defined as one which has a proven low failure rate of less than 1%
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:
- Ustekinumab (within 16 weeks prior to enrollment)
- Adalimum, infliximab, alefacept (within 8 weeks prior to enrollment)
Sites / Locations
- University of Szeged Department of Dermatology and AllergologyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cytori Celution System in Chronic Non-Healing diabetic Leg Ulcers
Arm Description
On the screening visit, the study physician will assign one eligible ulcer, as the target ulcer. Target ulcer will be treated and followed up during the whole study period. After liposuction investigational device will be applied on the target ulcer. After completion of Day1 visit all subjects enter the observation period and will come back to 3 on-site visits on day 7 day 14 and day 28
Outcomes
Primary Outcome Measures
Reduction rate of the wound size
The treatment response will be calculated from wound size before and after treatment.
Secondary Outcome Measures
Wound closure at Day 28
Percentage of patients achieving 50% wound closure at Day 28
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.
Improvement Wound pain
Improvement Wound pain visual analogue scale (VAS)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05274295
Brief Title
Open Label Single Arm Proof of Concept Trial to Evaluate the Efficacy and Safety of Cytori Celution System in Diabetic Leg Ulcers
Official Title
Open Label Single Arm Proof of Concept Trial to Evaluate the Efficacy and Safety of Cytori Celution System in Diabetic Leg Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2022 (Actual)
Primary Completion Date
April 30, 2022 (Anticipated)
Study Completion Date
April 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Szeged University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer, Leg Ulcer, Autologous Adipose Stromal Vascular Fraction, Mesenchymal Stem Cells, Adipose-Derived Mesenchymal Stem Cells
Keywords
Cytori Celution System
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cytori Celution System in Chronic Non-Healing diabetic Leg Ulcers
Arm Type
Experimental
Arm Description
On the screening visit, the study physician will assign one eligible ulcer, as the target ulcer. Target ulcer will be treated and followed up during the whole study period. After liposuction investigational device will be applied on the target ulcer. After completion of Day1 visit all subjects enter the observation period and will come back to 3 on-site visits on day 7 day 14 and day 28
Intervention Type
Device
Intervention Name(s)
Diabetic leg ulcer treatment with adipous SVF
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction rate of the wound size
Description
The treatment response will be calculated from wound size before and after treatment.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Wound closure at Day 28
Description
Percentage of patients achieving 50% wound closure at Day 28
Time Frame
28 days
Title
Improvement of Quality of Life (QoL) - EQ-5D-5L
Description
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
25 days
Title
Improvement Wound pain
Description
Improvement Wound pain visual analogue scale (VAS)
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Written informed consent
Males or females age ≥ 18
At least one diabetic leg ulcer with the following condition 3.1. Ulcer is present beyond 2 months 3.2. Conservative treatment not leading to improvement 3.3. Wound size between ≥5 and ≤100 cm2
Ability to safely undergo tissue harvest that is anticipated to yield >100mL of adipose tissue at a site that is free from infection and injury
Patients diagnosed with diabetes mellitus
Able and willing to work with the doctor, adhere to therapeutic prescriptions and appear on prescribed examinations
Normal or clinically not significant abnormal values based on investigator judgement on white blood cell count (WBC), C-reactive protein (CRP), Platelets, international normalized ratiod (INR), partial thromboplastin time (APTT), haemoglobin (Hgb), Renal and Liver function
Females of childbearing potential must have a negative pregnancy test at the Screen Visit
Females of childbearing potential must agree to use a highly effective method of birth control during the study. A highly effective method of birth control is defined as one which has a proven low failure rate of less than 1%
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:
Ustekinumab (within 16 weeks prior to enrollment)
Adalimum, infliximab, alefacept (within 8 weeks prior to enrollment)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Balázs Bende
Phone
+36-62-545-277
Email
bende.balazs@szte.hu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Balázs Bende, MD
Organizational Affiliation
Szeged University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lajos Kemény, Prof. Dr.
Organizational Affiliation
Szeged University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Szeged Department of Dermatology and Allergology
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lajos Kemény, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Balázs Bende, MD
First Name & Middle Initial & Last Name & Degree
Lajos Kemény, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Győző Szolnoky, MD PhD
First Name & Middle Initial & Last Name & Degree
Zoltán Veréb, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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Citation
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Open Label Single Arm Proof of Concept Trial to Evaluate the Efficacy and Safety of Cytori Celution System in Diabetic Leg Ulcers
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