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

NCT05072353 | Unknown DMC

• 1 other identifier: SEFFIDiFA_vers1.0
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot; Diabetic Foot Ulcer; Amputation

Outcome Measures

Primary Outcomes (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.

  6 months

Secondary Outcomes (7)

• healing time change

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

• risk factors afflicting healing/failure

  0 month

• reintervention

  6 months

• diabetic peripheral neuropathy

  0 month

• health-related quality of life change

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

Study Arms (1)

Treatment

EXPERIMENTAL

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.

Device: SEFFICARE

Interventions

SEFFICARE DEVICE

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.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria di Modena: lead
• University of Modena and Reggio Emilia: collaborator

Study Sites (1)

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

Modena, Emilia-Romagna, 41126, Italy

Location

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MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Roberto Silingardi, MD

  University of Modena and Reggio Emilia

  PRINCIPAL INVESTIGATOR

• Manuela Simoni, MD, PhD

  University of Modena and Reggio Emilia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicola Leone, MD

CONTACT

+390593961225; nicola.leone.md@gmail.com

Giulia Trevisi Borsari, MD

CONTACT

+390593961225; giuliatrevisiborsari@tiscali.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Prospective cohort study

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: October 8, 2021
• Study Start: December 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: October 1, 2024
• Last Updated: October 8, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)