Effectiveness of the Autologous Adipose Tissue Harvested With SEFFICARE Method for Treatment of DFU Minor Amputation (SEFFIDiFA)
Primary Purpose
Diabetic Foot, Diabetic Foot Ulcer, Amputation
Status
Not yet recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
SEFFICARE
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot
Eligibility Criteria
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);
Exclusion Criteria:
- 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;
- coagulopathy;
- infection of the harvesting site;
- local anesthetic allergy;
- immunosuppressive therapy.
Sites / Locations
- Ospedale Civile di Baggiovara (Modena), Azienda Ospedaliero-Universitaria di Modena, Università di Modena e Reggio Emilia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
healing time change
mean time for complete healing
risk factors afflicting healing/failure
evaluation of risk factors afflicting healing/failure
reintervention
time elapsed since index operation, type, and indication
diabetic peripheral neuropathy
the prevalence of DPN (probable) at baseline
health-related quality of life change
health-related quality of life evaluation, intended as changing of the SF-36 score
adverse events related to the treatment procedure
collection of eventual adverse events related to the treatment procedure
amount of adipose stem cells used for grafting
amount of adipose stem cells used for grafting
Full Information
NCT ID
NCT05072353
First Posted
September 10, 2021
Last Updated
September 30, 2021
Sponsor
Azienda Ospedaliero-Universitaria di Modena
Collaborators
University of Modena and Reggio Emilia
1. Study Identification
Unique Protocol Identification Number
NCT05072353
Brief Title
Effectiveness of the Autologous Adipose Tissue Harvested With SEFFICARE Method for Treatment of DFU Minor Amputation
Acronym
SEFFIDiFA
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2021 (Anticipated)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
October 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliero-Universitaria di Modena
Collaborators
University of Modena and Reggio Emilia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot, Diabetic Foot Ulcer, Amputation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective cohort study
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
SEFFICARE
Intervention Description
The SEFFI is a 5-step technique:
Preparation: the lower/lateral abdomen is chosen as the donor site.
Anesthesia: the donor site is injected with a local anesthetic.
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.
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).
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.
Primary Outcome Measure Information:
Title
Healing
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
healing time change
Description
mean time for complete healing
Time Frame
1, 2, 3, 4, 5, 6 months
Title
risk factors afflicting healing/failure
Description
evaluation of risk factors afflicting healing/failure
Time Frame
0 month
Title
reintervention
Description
time elapsed since index operation, type, and indication
Time Frame
6 months
Title
diabetic peripheral neuropathy
Description
the prevalence of DPN (probable) at baseline
Time Frame
0 month
Title
health-related quality of life change
Description
health-related quality of life evaluation, intended as changing of the SF-36 score
Time Frame
1, 2, 3, 4, 5, 6 months
Title
adverse events related to the treatment procedure
Description
collection of eventual adverse events related to the treatment procedure
Time Frame
6 months
Title
amount of adipose stem cells used for grafting
Description
amount of adipose stem cells used for grafting
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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);
Exclusion Criteria:
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;
coagulopathy;
infection of the harvesting site;
local anesthetic allergy;
immunosuppressive therapy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicola Leone, MD
Phone
+390593961225
Email
nicola.leone.md@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Giulia Trevisi Borsari, MD
Phone
+390593961225
Email
giuliatrevisiborsari@tiscali.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Silingardi, MD
Organizational Affiliation
University of Modena and Reggio Emilia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Manuela Simoni, MD, PhD
Organizational Affiliation
University of Modena and Reggio Emilia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale Civile di Baggiovara (Modena), Azienda Ospedaliero-Universitaria di Modena, Università di Modena e Reggio Emilia
City
Modena
State/Province
Emilia-Romagna
ZIP/Postal Code
41126
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicola Leone, MD
Phone
+390593961225
Email
nicola.leone.md@gmail.com
First Name & Middle Initial & Last Name & Degree
Roberto Silingardi, MD
First Name & Middle Initial & Last Name & Degree
Manuela Simoni, MD, PhD
First Name & Middle Initial & Last Name & Degree
Livio Casarini, PhD
First Name & Middle Initial & Last Name & Degree
Carla IL Greco, MD
First Name & Middle Initial & Last Name & Degree
Giulia Trevisi Borsari, MD
First Name & Middle Initial & Last Name & Degree
Nicola Leone, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Effectiveness of the Autologous Adipose Tissue Harvested With SEFFICARE Method for Treatment of DFU Minor Amputation
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