Treatment of Chronic Leg Ulcers With Autologous Stromal Vascular Fraction

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Treatment of Chronic Leg Ulcers With Autologous Stromal Vascular Fraction

Conditions
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Leg Ulcer

Intervention / Treatment
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* Procedure: Liposuction
* Other: Standard wound care
* Drug: Adipose-Derived Regenerative Cells


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous SVF + Standard of care<br>local injection around and under wound with autologous stromal vascular fraction. Standard wound care is given independent of this study. | Procedure: Liposuction<br>* Adipose tissue is harvested by liposuction from either abdomen or thighs.<br>Other: Standard wound care<br>* Patients will receive standard wound care and dressings independent of their participation in this study at the discretion of the wound nurses.<br>Drug: Adipose-Derived Regenerative Cells<br>* Cells isolated from adipose-derived tissue will be injected locally around and under the wound.<br>|
| Other: Standard of care<br>Standard wound care is given independent of this study. | Other: Standard wound care<br>* Patients will receive standard wound care and dressings independent of their participation in this study at the discretion of the wound nurses.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in wound size | Photography is taken every 2 weeks until complete wound healing. Final follow-up date regardless of complete wound healing or not is 6 months. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distal blood pressure measurement | Change in distal blood pressure measurement before and 6 months after treatment | 6 months | 
| Transcutaneous oxygen tension | Change in transcutaneous oxygen tension around the wound before and 6 months after treatment. | 6 months | 
| Treatment-related adverse events | Monitoring of any side effects or complications related to intervention | 6 months |