Treatment Study of Diabetic Foot Ulcers Using Autologous Stromal Vascular Fraction Cells for Patients with Non-healing Wounds

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What is this study about?

This study focuses on treating diabetic foot ulcers, which are wounds that develop on the feet of people with diabetes mellitus. These wounds can be difficult to heal and often don’t respond well to standard treatments. The study will test a new treatment method using stromal vascular fraction (SVF), which is made from a person’s own fat tissue.

The treatment involves collecting fat tissue from the patient’s body and processing it to obtain SVF cells. These cells are then prepared as a suspension for injection and administered through transdermal (through the skin) application directly into the wound area. The maximum amount of suspension that will be given is 15 milliliters in a single treatment session.

The purpose of this research is to determine if injecting SVF cells locally into foot ulcers that haven’t improved with standard wound care can help them heal. The study will monitor patients for 20 weeks after receiving the treatment to see if their wounds heal completely. This is a Phase II study, which means the treatment has already been tested for safety in earlier research.

1 Initial preparation

You will receive treatment for a diabetic foot ulcer that hasn’t improved with standard treatment for at least 2 months

The ulcer must be between 1 and 15 square centimeters in size after cleaning

Your blood sugar levels (HbA1c) will be checked and must be below 10%

2 Treatment procedure

The treatment involves using cells from your own fat tissue (called stromal vascular fraction or SVF)

The SVF will be prepared as an injection solution

The solution will be injected into the skin around the foot ulcer

3 Follow-up care

You will need to wear a special protective dressing throughout the study period

Regular check-ups will be scheduled to monitor the healing of your ulcer

The main evaluation of the treatment’s effectiveness will occur at week 20 after the injection

4 Study duration

The study begins in January 2024

The entire study continues until March 2028

Your participation will focus on the 20-week period following your treatment

5 Safety requirements

If you are of childbearing age, a pregnancy test must be negative before treatment

You must use reliable contraception throughout the treatment period

Your body mass index (BMI) must be above 18.5 to ensure sufficient fat tissue for the procedure

Who Can Join the Study?

Must be at least 18 years old
Must sign an informed consent form showing you understand and agree to participate
Must have type 1 or type 2 diabetes with HbA1c (blood sugar test) less than 10% within the last month
Must have a diabetic foot ulcer that:
– Is located on a toe or foot
– Measures between 1 and 15 square centimeters after cleaning
– Has not improved with standard treatment for at least 2 months
– Shows no signs of infection
– Has adequate blood flow to the affected limb
Must have confirmed nerve damage (neuropathy) in the foot, tested with a special filament
Must have a body mass index (BMI) of at least 18.5 kg/m²
Must be in good overall health based on medical examination
Must be willing to wear prescribed dressing and pressure relief system daily throughout the study
Must have valid health insurance
For women who can become pregnant:
– Must have a negative pregnancy test
– Must use reliable contraception during the study
For men:
– Must use reliable contraception during the study

Who Cannot Join the Study?

Age below 18 years or above 65 years
Pregnant or breastfeeding women
Active infection in the foot ulcer area
Presence of osteomyelitis (bone infection) in the affected foot
Uncontrolled diabetes (blood sugar levels consistently above normal range)
Severe peripheral vascular disease (poor blood circulation in the legs)
Active cancer or history of cancer in the past 5 years
Severe kidney disease requiring dialysis
History of blood clotting disorders
Current participation in other clinical trials
Known allergies to study-related materials
Inability to follow study procedures or attend follow-up visits
Major amputation in the affected limb
Presence of gangrene (death of body tissue) in the affected foot
Severe heart or lung disease

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Hopital Beaujon	Clichy	France
Advrrejmvc Pzcmalmw Hwwsukyd Do Mlgmmslys	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	09.01.2024

Trial locations

Investigated drugs:

Autologous Adipose Tissue-Derived Stromal Vascular Fraction Cells

Stromal Vascular Fraction (SVF)
This is a cellular therapy derived from a patient’s own (autologous) adipose tissue (fat). The treatment involves collecting fat tissue from the patient, processing it to isolate the stromal vascular fraction, and then injecting these cells locally into diabetic foot ulcers. SVF contains various types of cells, including stem cells, that may help in wound healing and tissue regeneration. This is being studied as a new approach for treating diabetic foot ulcers that haven’t responded to standard treatments.

Investigated diseases:

Diabetic foot

Diabetic Foot Ulcer – A condition that occurs in people with diabetes where open sores or wounds form on the feet, typically on the bottom surface. These ulcers develop due to a combination of reduced blood flow and nerve damage caused by long-term high blood sugar levels. The condition usually begins as a small wound or blister that progressively deepens and may involve multiple layers of skin and tissue. The reduced sensation in diabetic feet means that small injuries often go unnoticed until they develop into larger wounds. The ulcers commonly appear in areas of the foot that experience pressure during walking or standing.

Trial ID:

2024-516342-19-00

NCT ID:

NCT02866565

Trial Phase:

Therapeutic exploratory (Phase II)

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Treatment Study of Diabetic Foot Ulcers Using Autologous Stromal Vascular Fraction Cells for Patients with Non-healing Wounds

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?