Effectiveness of the Autologous Adipose Tissue Harvested With SEFFICARE Method for Treatment of DFU Minor Amputation
NCT ID: NCT05072353
Last Updated: 2021-10-08
Study Results
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Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2021-12-31
2024-10-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
DFU 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.
SEFFICARE
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.
Interventions
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SEFFICARE
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.
Eligibility Criteria
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Inclusion Criteria
* 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);
Exclusion Criteria
* 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;
* coagulopathy;
* infection of the harvesting site;
* local anesthetic allergy;
* immunosuppressive therapy.
18 Years
ALL
No
Sponsors
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University of Modena and Reggio Emilia
OTHER
Azienda Ospedaliero-Universitaria di Modena
OTHER
Responsible Party
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Nicola Leone
MD
Principal Investigators
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Roberto Silingardi, MD
Role: PRINCIPAL_INVESTIGATOR
University of Modena and Reggio Emilia
Manuela Simoni, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Modena and Reggio Emilia
Locations
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Ospedale Civile di Baggiovara (Modena), Azienda Ospedaliero-Universitaria di Modena, Università di Modena e Reggio Emilia
Modena, Emilia-Romagna, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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SEFFIDiFA_vers1.0
Identifier Type: -
Identifier Source: org_study_id
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