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Diabetic FootSEFFIDiFANCT05072353

Effectiveness of the Autologous Adipose Tissue Harvested With SEFFICARE Method for Treatment of DFU Minor Amputation

A study testing SEFFICARE in people with Diabetic Foot and Diabetic Foot Ulcer, run by Azienda Ospedaliero-Universitaria di Modena at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Diabetic foot ulcers (DFU) are one of the complications of diabetes mellitus resulting from multiple causes such as neuropathy, ischemia, and infection that contribute to morbidity and amputation. The prevalence of DFU has been estimated to be 3 to 5 times higher than the overall population. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Foot, Diabetic Foot Ulcer, Amputation
What is being tested?
SEFFICARE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteItaly
Study dates
Dec 2021to Oct 2024
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

  • type-1 and type-2 diabetes mellitus
  • age >18-years
  • both sexes
  • chronic diabetic distal ulcers/gangrene (digital or forefoot) intended as W-grade 1 to 3 according to WifI classification;
  • absence of active vascular issues or patients undergoing lower extremity revascularization to improve peripheral perfusion intended as I-grade 0 to 2 according to WIfi classification;
  • absence of infection signs or presence of soft tissue infection intended as fI-grade 0 to 2 according to Wifi classification, without radiologic signs of bone infection (negative X-ray for osteolytic lesions);

Who cannot join

  • extensive ulcers with deep involving proximal forefoot and/or deep, full-thickness heel ulcer, with calcaneal involvement (W-grade 3 according to WifI classification);
  • active vascular issues [I-grade 3 according to Wifi classification];
  • ulcers with signs of moderate and/or severe infection (osteomyelitis and/or sepsis) [fI-grade 3 according to WifI classification];
  • severe comorbidities such as severe heart failure, liver failure, and/or psychiatric disorder;
  • previous oncological treatments (past 5 years) or ongoing and/or neoplastic lesions;
  • corticosteroid therapy;
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  • coagulopathy;
  • infection of the harvesting site;
  • local anesthetic allergy;
  • immunosuppressive therapy.

Trial locations and contacts

1 site in 1 country.

Nicola Leone, MD contact

+390593961225

nicola.leone.md@gmail.com

Giulia Trevisi Borsari, MD contact

+390593961225

giuliatrevisiborsari@tiscali.it

Italy1 site

  • Ospedale Civile di Baggiovara (Modena), Azienda Ospedaliero-Universitaria di Modena, Università di Modena e Reggio Emilia

    Modena, Emilia-Romagna, 41126

    Nicola Leone, MD, +390593961225, nicola.leone.md@gmail.com

    Roberto Silingardi, MD

Other trials in Italy

About this study

Official title: Autologous Adipose Tissue Harvested With Superficial Enhanced Fluid Fat Injection (SEFFICARE) Method for Treatment of Diabetic Foot Ulcer Undergoing Minor Amputation (SEFFIDiFA): Proposal of Basic Research and Prospective Observational Study

Diabetic foot ulcers (DFU) are one of the complications of diabetes mellitus resulting from multiple causes such as neuropathy, ischemia, and infection that contribute to morbidity and amputation. The prevalence of DFU has been estimated to be 3 to 5 times higher than the overall population. Minor amputations (digital or transmetatarsal) are the treatment of choice in case of irreversible DFU. However, many minor amputations do not heal and require re-amputation. Improvements of healing rate after adipose stem cells (ASCs) injection through micro-fragmented autologous adipose tissue of the amputation stump following minor DFU amputation were demonstrated. The use of ASCs obtained from the superficial enhanced fluid fat injection technique (SEFFICARE) to improve the healing process after DFUs minor amputation is the object of the present study.

A single-center non-randomized prospective observational study will be performed.

The recruited patients will undergo local injection of superficial enhanced fluid fat after a lower limb minor amputation. Laboratory analysis to evaluate the composition of the tissue and stromal cell components harvested from adipose tissue with SEFFICARE system by using digital droplets PCR. These data will serve for making associations between the clinical outcome and characteristics of the cell population administered to each patient.

Read the detailed description

Diabetic foot ulcers (DFU) are one of the complications of diabetes mellitus resulting from multiple causes such as neuropathy, ischemia, and infection that contribute to morbidity and amputation. The prevalence of DFU has been estimated to be 3 to 5 times higher than the overall population. Minor amputations (digital or transmetatarsal) are the treatment of choice in case of irreversible DFU. However, many minor amputations do not heal and require re-amputation. Improvements of healing rate after adipose stem cells (ASCs) injection through micro-fragmented autologous adipose tissue of the amputation stump following minor DFU amputation were demonstrated. The use of ASCs obtained from the superficial enhanced fluid fat injection technique (SEFFICARE) to improve the healing process after DFUs minor amputation is the object of the present study.

STUDY DESIGN: Single-center non-randomized prospective observational cohort study.

TREATMENT: Local injection of superficial enhanced fluid fat after a lower limb minor amputation. Laboratory analysis to evaluate the composition of the tissue and stromal cell components harvested from adipose tissue with SEFFICARE system by using digital droplets PCR. These data will serve for making associations between the clinical outcome and characteristics of the cell population administered to each patient.

INCLUSION CRITERIA:

  • type-1 and type-2 diabetes mellitus
  • age >18-years
  • both sexes
  • chronic diabetic distal ulcers/gangrene (digital or forefoot) intended as W-grade 1 to 3 according to WifI classification;
  • absence of active vascular issues or patients undergoing lower extremity revascularization to improve peripheral perfusion intended as I-grade 0 to 2 according to WIfi classification;
  • absence of infection signs or presence of soft tissue infection intended as fI-grade 0 to 2 according to Wifi classification, without radiologic signs of bone infection (negative X-ray for osteolytic lesions); SAMPLE SIZE: The correct sample size was calculated considering as primary endpoint the proportion of the healing stump. The sample size was calculated with the Score Z test comparing one proportion based on literature results to a reference value. Using a significance level of 0.05, power of 0.8, setting the H0 proportion of 0.80 and the Ha of 0.6 respectively, the result was 36 subjects. An additional 10% of subjects was considered taking into account eventual drop-out during the study. The final sample size inflated to 40 patients.

ENDPOINTS: Primary endpoint: percentage of stump healing; Secondary endpoints:

  • mean time for complete healing;
  • evaluation of risk factors afflicting healing/failure;
  • evaluation of reintervention (time elapsed since index operation, type, and indication);
  • the prevalence of peripheral diabetic polyneuropathy at baseline;
  • the percentage change in the pain score of NRS;
  • health-related quality of life evaluation, intended as changing of the SF-36 score;
  • collection of eventual adverse events related to the treatment procedure and eventual posthoc analysis.
  • evaluation of the adipose harvested tissue composition and stromal cell components STATISTICAL ANALYSIS: The categorical endpoints, i.e., the difference in the healing rate will be assessed with the chi-square test or Fisher's exact test. The continuous variables will be calculated by Kaplan-Meier curves and log-rank test. A univariate and multivariate logistic regression analysis will be applied to identify influencing factors on the categorical endpoints. To test the influence of multiple variables on continuous data, one/two-way ANOVA will be performed with Bonferroni's post-test.
Being tested
SEFFICARE
Medical subject headings
Diabetic Foot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SEFFICAREDevice

    The SEFFI is a 5-step technique:

    1. Preparation: the lower/lateral abdomen is chosen as the donor site.
    2. Anesthesia: the donor site is injected with a local anesthetic.
    3. Harvesting: a 0.8 mm or 0.5 mm cannula connected to a 10-ml VacLok® syringe is used to harvest the adipose tissue. The total amount of the harvested tissue could vary from 10 to 30 mL.
    4. Washing: The syringe containing the lipoaspirate tissue is immediately filled with sterile physiological solution. After some minutes the syringes in the decanting stand will show a separation by the gravity of the tissue (top) from the physiological solution (bottom).
    5. Fluidification: the syringe containing the adipose tissue should be connected to an empty 10 ml syringe. After pushing the tissue about 3 times from one syringe to the other, a good fluidification of the tissue is obtained.

    The resulting tissue (2.5 mL per syringe) is ready for grafting the amputation wound.

Study groups in NCT05072353
Study groupRoleWhat they receive
TreatmentExperimentalDFU Patients are subjected to digital or transmetatarsal amputation. The treatment is provided during the amputation surgical session according to the SEFFI technique. The SEFFICARE® system (SEFFILINE S.r.l., Via delle Lame, 98, 40122 Bologna, Italy) is a disposable commercially available device. The device is provided in a sterile bag without any drugs. The SEFFI is a 5-step technique meaning preparation, anesthesia, harvesting, washing, and fluidification. The resulting tissue (2.5 mL per syringe) is ready for grafting. The stumps are closed by primary intention following adipose tissue injection.
Receives: Device: SEFFICARE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Healing

    Healing was defined as complete re-epithelialization of the stump after suture removal without signs of cutaneous suffering, inflammation, infection, local swelling as determined by one investigator.

    Measured: 6 months

Secondary outcomes (7)

  1. healing time change

    mean time for complete healing

    Measured: 1, 2, 3, 4, 5, 6 months

  2. risk factors afflicting healing/failure

    evaluation of risk factors afflicting healing/failure

    Measured: 0 month

  3. reintervention

    time elapsed since index operation, type, and indication

    Measured: 6 months

  4. diabetic peripheral neuropathy

    the prevalence of DPN (probable) at baseline

    Measured: 0 month

  5. health-related quality of life change

    health-related quality of life evaluation, intended as changing of the SF-36 score

    Measured: 1, 2, 3, 4, 5, 6 months

  6. adverse events related to the treatment procedure

    collection of eventual adverse events related to the treatment procedure

    Measured: 6 months

  7. amount of adipose stem cells used for grafting

    amount of adipose stem cells used for grafting

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2021
  2. Study startDec 2021 (estimated)
  3. Primary completionJun 2022 (estimated)
  4. Study completionOct 2024 (estimated)

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Prospective cohort study
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05072353
Sponsor's protocol ID
SEFFIDiFA_vers1.0
Acronym
SEFFIDiFA
Status last verified
Sep 2021
First submitted
10 Sep 2021
Last updated
8 Oct 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Alvaro-Afonso FJ, Sanz-Corbalan I, Lazaro-Martinez JL, Kakagia D, Papanas N. Adipose-Derived Mesenchymal Stem Cells in the Treatment of Diabetic Foot Ulcers: A Review of Preclinical and Clinical Studies. Angiology. 2020 Oct;71(9):853-863. doi: 10.1177/0003319720939467. Epub 2020 Jul 29.

    PubMed 32723090

  • Armstrong DG, Boulton AJM, Bus SA. Diabetic Foot Ulcers and Their Recurrence. N Engl J Med. 2017 Jun 15;376(24):2367-2375. doi: 10.1056/NEJMra1615439. No abstract available.

    PubMed 28614678

  • Zhang P, Lu J, Jing Y, Tang S, Zhu D, Bi Y. Global epidemiology of diabetic foot ulceration: a systematic review and meta-analysis dagger. Ann Med. 2017 Mar;49(2):106-116. doi: 10.1080/07853890.2016.1231932. Epub 2016 Nov 3.

    PubMed 27585063

  • Frykberg RG, Zgonis T, Armstrong DG, Driver VR, Giurini JM, Kravitz SR, Landsman AS, Lavery LA, Moore JC, Schuberth JM, Wukich DK, Andersen C, Vanore JV; American College of Foot and Ankle Surgeons. Diabetic foot disorders. A clinical practice guideline (2006 revision). J Foot Ankle Surg. 2006 Sep-Oct;45(5 Suppl):S1-66. doi: 10.1016/S1067-2516(07)60001-5.

    PubMed 17280936

  • Hingorani A, LaMuraglia GM, Henke P, Meissner MH, Loretz L, Zinszer KM, Driver VR, Frykberg R, Carman TL, Marston W, Mills JL Sr, Murad MH. The management of diabetic foot: A clinical practice guideline by the Society for Vascular Surgery in collaboration with the American Podiatric Medical Association and the Society for Vascular Medicine. J Vasc Surg. 2016 Feb;63(2 Suppl):3S-21S. doi: 10.1016/j.jvs.2015.10.003.

    PubMed 26804367

  • Prompers L, Huijberts M, Apelqvist J, Jude E, Piaggesi A, Bakker K, Edmonds M, Holstein P, Jirkovska A, Mauricio D, Ragnarson Tennvall G, Reike H, Spraul M, Uccioli L, Urbancic V, Van Acker K, van Baal J, van Merode F, Schaper N. High prevalence of ischaemia, infection and serious comorbidity in patients with diabetic foot disease in Europe. Baseline results from the Eurodiale study. Diabetologia. 2007 Jan;50(1):18-25. doi: 10.1007/s00125-006-0491-1. Epub 2006 Nov 9.

    PubMed 17093942

  • Prompers L, Schaper N, Apelqvist J, Edmonds M, Jude E, Mauricio D, Uccioli L, Urbancic V, Bakker K, Holstein P, Jirkovska A, Piaggesi A, Ragnarson-Tennvall G, Reike H, Spraul M, Van Acker K, Van Baal J, Van Merode F, Ferreira I, Huijberts M. Prediction of outcome in individuals with diabetic foot ulcers: focus on the differences between individuals with and without peripheral arterial disease. The EURODIALE Study. Diabetologia. 2008 May;51(5):747-55. doi: 10.1007/s00125-008-0940-0. Epub 2008 Feb 23.

    PubMed 18297261

  • Thorud JC, Jupiter DC, Lorenzana J, Nguyen TT, Shibuya N. Reoperation and Reamputation After Transmetatarsal Amputation: A Systematic Review and Meta-Analysis. J Foot Ankle Surg. 2016 Sep-Oct;55(5):1007-12. doi: 10.1053/j.jfas.2016.05.011. Epub 2016 Jul 27.

    PubMed 27475711

  • Uccioli L, Izzo V, Meloni M, Vainieri E, Ruotolo V, Giurato L. Non-healing foot ulcers in diabetic patients: general and local interfering conditions and management options with advanced wound dressings. J Wound Care. 2015 Apr;24(4 Suppl):35-42. doi: 10.12968/jowc.2015.24.Sup4b.35.

    PubMed 25853647

  • Vizoso FJ, Eiro N, Cid S, Schneider J, Perez-Fernandez R. Mesenchymal Stem Cell Secretome: Toward Cell-Free Therapeutic Strategies in Regenerative Medicine. Int J Mol Sci. 2017 Aug 25;18(9):1852. doi: 10.3390/ijms18091852.

    PubMed 28841158

  • Gimble JM, Guilak F, Bunnell BA. Clinical and preclinical translation of cell-based therapies using adipose tissue-derived cells. Stem Cell Res Ther. 2010 Jun 29;1(2):19. doi: 10.1186/scrt19.

    PubMed 20587076

  • Gadelkarim M, Abushouk AI, Ghanem E, Hamaad AM, Saad AM, Abdel-Daim MM. Adipose-derived stem cells: Effectiveness and advances in delivery in diabetic wound healing. Biomed Pharmacother. 2018 Nov;107:625-633. doi: 10.1016/j.biopha.2018.08.013. Epub 2018 Aug 14.

    PubMed 30118878

  • Zuk PA, Zhu M, Ashjian P, De Ugarte DA, Huang JI, Mizuno H, Alfonso ZC, Fraser JK, Benhaim P, Hedrick MH. Human adipose tissue is a source of multipotent stem cells. Mol Biol Cell. 2002 Dec;13(12):4279-95. doi: 10.1091/mbc.e02-02-0105.

    PubMed 12475952

  • Caruana G, Bertozzi N, Boschi E, Pio Grieco M, Grignaffini E, Raposio E. Role of adipose-derived stem cells in chronic cutaneous wound healing. Ann Ital Chir. 2015 Jan-Feb;86(1):1-4.

    PubMed 25818696

  • Salgado AJ, Reis RL, Sousa NJ, Gimble JM. Adipose tissue derived stem cells secretome: soluble factors and their roles in regenerative medicine. Curr Stem Cell Res Ther. 2010 Jun;5(2):103-10. doi: 10.2174/157488810791268564.

    PubMed 19941460

Questions about this trial

What is this clinical trial studying?

A study testing SEFFICARE in people with Diabetic Foot and Diabetic Foot Ulcer, run by Azienda Ospedaliero-Universitaria di Modena at 1 site in Italy.

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 6 inclusion and 10 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 8 Oct 2021. 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 Italy. 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 Nicola Leone, MD (+390593961225, nicola.leone.md@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Healing (time frame: 6 months). 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 NCT05072353, which also lists 36 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 8 Oct 2021.

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