Leg Ulcer
Conditions
Brief summary
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
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.
Interventions
PROCEDURELiposuction
Adipose tissue is harvested by liposuction from either abdomen or thighs.
OTHERStandard wound care
Patients will receive standard wound care and dressings independent of their participation in this study at the discretion of the wound nurses.
Cells isolated from adipose-derived tissue will be injected locally around and under the wound.
Sponsors
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in wound size | 6 months | Photography is taken every 2 weeks until complete wound healing. Final follow-up date regardless of complete wound healing or not is 6 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distal blood pressure measurement | 6 months | Change in distal blood pressure measurement before and 6 months after treatment |
| Transcutaneous oxygen tension | 6 months | Change in transcutaneous oxygen tension around the wound before and 6 months after treatment. |
| Treatment-related adverse events | 6 months | Monitoring of any side effects or complications related to intervention |
Countries
Denmark
Contacts
Primary ContactNavid M Toyserkani, MD
Outcome results
None listed