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

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

Interventions

DEVICE

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.

Sponsors & Collaborators

• University of Modena and Reggio Emilia

  collaborator OTHER

• Azienda Ospedaliero-Universitaria di Modena

  lead OTHER

Principal Investigators

• Roberto Silingardi, MD · University of Modena and Reggio Emilia

• Manuela Simoni, MD, PhD · University of Modena and Reggio Emilia

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-12-31

Primary Completion

2022-06-30

Completion

2024-10-31

Countries

• Italy

Study Locations