Treatment of Chronic Leg Ulcers With Autologous Stromal Vascular Fraction

Odense University Hospital

Status: Unknown

Conditions: Leg Ulcer

Treatments: Procedure: Liposuction; Drug: Adipose-Derived Regenerative Cells; Other: Standard wound care

Study type: Interventional

Funder types: Other

Identifiers

NCT02987101

S-201502002

Details and patient eligibility

About

Chronic leg ulcers are associated with decreased quality of life and an increased mortality. In many cases these ulcers are treated conservatively and the healing time can be several months. In this open randomized clinical trial we will examine if we can accelerate wound healing when using autologous stromal vascular fraction as an adjunct to standard wound care.

Full description

Chronic leg ulcers are associated with decreased quality of life and an increased mortality. In many cases these ulcers are treated conservatively and the healing time can be several months. In this open randomized clinical trial we will examine if we can accelerate wound healing when using autologous stromal vascular fraction (SVF) as an adjunct to standard wound care.

The plan is to include 30 patients with arterial or arteriovenous chronic leg ulcers and these are randomized in two groups of which one receives standard wound care only and the other group receives autologous stromal vascular fraction treatment in addition to standard wound care.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Arteriovenous chronic leg ulcer
• Present beyond 4 months
• Conservative treatment not leading to progress
• Wound size between 2-30cm2
• ankle-brachial index (ABI) ( 50-90% and/or toe pressure 50-70% and where ankle pressure > 60 mmHg or toe pressure > 40 mmHg
• Written informed consent

Exclusion criteria

• Uncontrolled wound infection
• Osteomyelitis
• Hemoglobin <6.0mmol/L
• HbA1c >80mmol/mol
• Underlying malignancy
• Pregnancy or lactating
• Renal insufficiency requiring dialysis
• Charcot foot
• Underlying malignancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Autologous SVF + Standard of care

Experimental group

Description:

local injection around and under wound with autologous stromal vascular fraction. Standard wound care is given independent of this study.

Treatment:

Procedure: Liposuction

Other: Standard wound care

Drug: Adipose-Derived Regenerative Cells

Standard of care

Other group

Description:

Standard wound care is given independent of this study.

Treatment:

Other: Standard wound care