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

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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%
Step 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
Step 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
Step 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
Step 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 trial?

11 criteria

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 trial?

15 criteria

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

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Assistance Publique Hopitaux De Marseille
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Marseille, France
Centre Hospitalier Universitaire Rouen
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Rouen, France
Hopital Beaujon
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Clichy, France

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Investigated drugs

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.

Autologous Adipose Tissue-Derived Stromal Vascular Fraction Cells

What is already known about the treatment

Stromal Vascular Fraction (SVF) – An autologous cell-based therapy administered through local injection, derived from the patient's own adipose (fat) tissue. SVF contains a mixture of regenerative cells including stem cells, blood vessel-forming cells, and immune cells that work together to promote tissue healing and regeneration. This investigational treatment is currently being studied in clinical trials for diabetic foot ulcers that haven't responded to conventional treatments, with the mechanism of action involving tissue repair and new blood vessel formation at the molecular level. SVF represents a novel approach in regenerative medicine, classified as an advanced therapy medicinal product (ATMP) under current medical regulations.

Investigated diseases

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.