Diabetic Foot UlcerNCT05274295
Open Label Single Arm Proof of Concept Trial to Evaluate the Efficacy and Safety of Cytori Celution System in Diabetic Leg Ulcers
A study testing Diabetic leg ulcer treatment with adipous SVF in people with Diabetic Foot Ulcer and Leg Ulcer, run by Szeged University at 1 site in Hungary.
Trial summary
To evaluate the efficacy and safety of Cytori Celution System in Hungarian patients with diabetic leg ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, Leg Ulcer, Autologous Adipose Stromal Vascular Fraction
- What is being tested?
- Diabetic leg ulcer treatment with adipous SVF
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteHungary
- Study dates
- 28 Feb 2022to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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%
Who cannot join
- 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
Show all 21Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Hungary1 site, 1 recruiting
- Recruiting
University of Szeged Department of Dermatology and Allergology
Szeged, 6720
Lajos Kemény, Prof. Dr.
Balázs Bende, MD
About this study
To evaluate the efficacy and safety of Cytori Celution System in Hungarian patients with diabetic leg ulcers.
Read the 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
- Being tested
- Diabetic leg ulcer treatment with adipous SVF
- Keywords
- Cytori Celution System
- Medical subject headings
- Diabetic Foot, Leg Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetic leg ulcer treatment with adipous SVFDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Cytori Celution System in Chronic Non-Healing diabetic Leg Ulcers | Experimental | 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 Receives: Device: Diabetic leg ulcer treatment with adipous SVF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction rate of the wound size
The treatment response will be calculated from wound size before and after treatment.
Measured: 28 days
Secondary outcomes (3)
Wound closure at Day 28
Percentage of patients achieving 50% wound closure at Day 28
Measured: 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.
Measured: 25 days
Improvement Wound pain
Improvement Wound pain visual analogue scale (VAS)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start28 Feb 2022
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Szeged University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Balázs Bende, MD, Principal investigator, Szeged UniversityLajos Kemény, Prof. Dr., Principal investigator, Szeged University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274295
- Sponsor's protocol ID
- SZTE-CCS-DLU-01
- Status last verified
- Mar 2022
- First submitted
- 1 Mar 2022
- Last updated
- 3 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dominici M, Le Blanc K, Mueller I, Slaper-Cortenbach I, Marini F, Krause D, Deans R, Keating A, Prockop Dj, Horwitz E. Minimal criteria for defining multipotent mesenchymal stromal cells. The International Society for Cellular Therapy position statement. Cytotherapy. 2006;8(4):315-7. doi: 10.1080/14653240600855905.
PubMed 16923606Le Blanc K, Ringden O. Immunomodulation by mesenchymal stem cells and clinical experience. J Intern Med. 2007 Nov;262(5):509-25. doi: 10.1111/j.1365-2796.2007.01844.x.
PubMed 17949362Galipeau J, Krampera M, Barrett J, Dazzi F, Deans RJ, DeBruijn J, Dominici M, Fibbe WE, Gee AP, Gimble JM, Hematti P, Koh MB, LeBlanc K, Martin I, McNiece IK, Mendicino M, Oh S, Ortiz L, Phinney DG, Planat V, Shi Y, Stroncek DF, Viswanathan S, Weiss DJ, Sensebe L. International Society for Cellular Therapy perspective on immune functional assays for mesenchymal stromal cells as potency release criterion for advanced phase clinical trials. Cytotherapy. 2016 Feb;18(2):151-9. doi: 10.1016/j.jcyt.2015.11.008. Epub 2015 Dec 23.
PubMed 26724220Horwitz EM, Le Blanc K, Dominici M, Mueller I, Slaper-Cortenbach I, Marini FC, Deans RJ, Krause DS, Keating A; International Society for Cellular Therapy. Clarification of the nomenclature for MSC: The International Society for Cellular Therapy position statement. Cytotherapy. 2005;7(5):393-5. doi: 10.1080/14653240500319234.
PubMed 16236628Meng X, Sun B, Xue M, Xu P, Hu F, Xiao Z. Comparative analysis of microRNA expression in human mesenchymal stem cells from umbilical cord and cord blood. Genomics. 2016 Apr;107(4):124-31. doi: 10.1016/j.ygeno.2016.02.006. Epub 2016 Feb 26.
PubMed 26921857Volz AC, Huber B, Kluger PJ. Adipose-derived stem cell differentiation as a basic tool for vascularized adipose tissue engineering. Differentiation. 2016 Jul-Aug;92(1-2):52-64. doi: 10.1016/j.diff.2016.02.003. Epub 2016 Mar 11.
PubMed 26976717Zachar V, Rasmussen JG, Fink T. Isolation and growth of adipose tissue-derived stem cells. Methods Mol Biol. 2011;698:37-49. doi: 10.1007/978-1-60761-999-4_4.
PubMed 21431509Schwartz RE, Reyes M, Koodie L, Jiang Y, Blackstad M, Lund T, Lenvik T, Johnson S, Hu WS, Verfaillie CM. Multipotent adult progenitor cells from bone marrow differentiate into functional hepatocyte-like cells. J Clin Invest. 2002 May;109(10):1291-302. doi: 10.1172/JCI15182.
PubMed 12021244Tang Y, Yasuhara T, Hara K, Matsukawa N, Maki M, Yu G, Xu L, Hess DC, Borlongan CV. Transplantation of bone marrow-derived stem cells: a promising therapy for stroke. Cell Transplant. 2007;16(2):159-69.
PubMed 17474297
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Single Arm Proof of Concept Trial to Evaluate the Efficacy and Safety of Cytori Celution System in Diabetic Leg Ulcers
- ClinicalTrials.gov ID
- NCT05274295
- Acronym / sponsor ID
- SZTE-CCS-DLU-01
- Conditions
- Diabetic Foot Ulcer, Leg Ulcer, Autologous Adipose Stromal Vascular Fraction, Mesenchymal Stem Cells, Adipose-Derived Mesenchymal Stem Cells
- Keywords
- Cytori Celution System
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Szeged UniversityUniversity, hospital or other
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 10 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cytori Celution System in Chronic Non-Healing diabetic Leg Ulcers | Experimental | Device: Diabetic leg ulcer treatment with adipous SVFOn 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diabetic leg ulcer treatment with adipous SVFThe 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. | Device | Cytori Celution System in Chronic Non-Healing diabetic Leg Ulcers |
Primary outcome
Reduction rate of the wound size
Time frame: 28 days
The treatment response will be calculated from wound size before and after treatment.
3 secondary outcomes
Wound closure at Day 28
Time frame: 28 days
Improvement of Quality of Life (QoL) - EQ-5D-5L
Time frame: 25 days
Improvement Wound pain
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
- Background: PubMed 16923606Dominici M, Le Blanc K, Mueller I, Slaper-Cortenbach I, Marini F, Krause D, Deans R, Keating A, Prockop Dj, Horwitz E. Minimal criteria for defining multipotent mesenchymal stromal cells. The International Society for Cellular Therapy position statement. Cytotherapy. 2006;8(4):315-7. doi: 10.1080/14653240600855905.
- Background: PubMed 17949362Le Blanc K, Ringden O. Immunomodulation by mesenchymal stem cells and clinical experience. J Intern Med. 2007 Nov;262(5):509-25. doi: 10.1111/j.1365-2796.2007.01844.x.
- Background: PubMed 26724220Galipeau J, Krampera M, Barrett J, Dazzi F, Deans RJ, DeBruijn J, Dominici M, Fibbe WE, Gee AP, Gimble JM, Hematti P, Koh MB, LeBlanc K, Martin I, McNiece IK, Mendicino M, Oh S, Ortiz L, Phinney DG, Planat V, Shi Y, Stroncek DF, Viswanathan S, Weiss DJ, Sensebe L. International Society for Cellular Therapy perspective on immune functional assays for mesenchymal stromal cells as potency release criterion for advanced phase clinical trials. Cytotherapy. 2016 Feb;18(2):151-9. doi: 10.1016/j.jcyt.2015.11.008. Epub 2015 Dec 23.
- Background: PubMed 16236628Horwitz EM, Le Blanc K, Dominici M, Mueller I, Slaper-Cortenbach I, Marini FC, Deans RJ, Krause DS, Keating A; International Society for Cellular Therapy. Clarification of the nomenclature for MSC: The International Society for Cellular Therapy position statement. Cytotherapy. 2005;7(5):393-5. doi: 10.1080/14653240500319234.
- Background: PubMed 26921857Meng X, Sun B, Xue M, Xu P, Hu F, Xiao Z. Comparative analysis of microRNA expression in human mesenchymal stem cells from umbilical cord and cord blood. Genomics. 2016 Apr;107(4):124-31. doi: 10.1016/j.ygeno.2016.02.006. Epub 2016 Feb 26.
- Background: PubMed 26976717Volz AC, Huber B, Kluger PJ. Adipose-derived stem cell differentiation as a basic tool for vascularized adipose tissue engineering. Differentiation. 2016 Jul-Aug;92(1-2):52-64. doi: 10.1016/j.diff.2016.02.003. Epub 2016 Mar 11.
- Background: PubMed 21431509Zachar V, Rasmussen JG, Fink T. Isolation and growth of adipose tissue-derived stem cells. Methods Mol Biol. 2011;698:37-49. doi: 10.1007/978-1-60761-999-4_4.
- Background: PubMed 12021244Schwartz RE, Reyes M, Koodie L, Jiang Y, Blackstad M, Lund T, Lenvik T, Johnson S, Hu WS, Verfaillie CM. Multipotent adult progenitor cells from bone marrow differentiate into functional hepatocyte-like cells. J Clin Invest. 2002 May;109(10):1291-302. doi: 10.1172/JCI15182.
- Background: PubMed 17474297Tang Y, Yasuhara T, Hara K, Matsukawa N, Maki M, Yu G, Xu L, Hess DC, Borlongan CV. Transplantation of bone marrow-derived stem cells: a promising therapy for stroke. Cell Transplant. 2007;16(2):159-69.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Balázs Bende, MD principal investigator
Szeged University
Lajos Kemény, Prof. Dr. principal investigator
Szeged University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetic leg ulcer treatment with adipous SVF in people with Diabetic Foot Ulcer and Leg Ulcer, run by Szeged University at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Balázs Bende (+36-62-545-277, bende.balazs@szte.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction rate of the wound size (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05274295, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2022.