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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous SVF + Standard of care | Experimental | local injection around and under wound with autologous stromal vascular fraction. Standard wound care is given independent of this study. |
|
| Standard of care | Other | Standard wound care is given independent of this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposuction | Procedure | Adipose tissue is harvested by liposuction from either abdomen or thighs. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Navid M Toyserkani, MD | Contact | +4550383833 | navid.m.toyserkani@rsyd.dk |
| Name | Affiliation | Role |
|---|---|---|
| Jens A Sørensen, MD PhD | Dept. Plastic Surgery, OUH, Consultant, Professor | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital | Recruiting | Odense | 5000 | Denmark |
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| ID | Term |
|---|---|
| D007871 | Leg Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D015187 | Lipectomy |
| ID | Term |
|---|---|
| D003357 | Cosmetic Techniques |
| D013812 | Therapeutics |
| D050110 | Bariatric Surgery |
| D049088 | Bariatrics |
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| Standard wound care | Other | Patients will receive standard wound care and dressings independent of their participation in this study at the discretion of the wound nurses. |
|
| Adipose-Derived Regenerative Cells | Drug | Cells isolated from adipose-derived tissue will be injected locally around and under the wound. |
|
| 6 months |
| Treatment-related adverse events | Monitoring of any side effects or complications related to intervention | 6 months |
| D000073319 |
| Obesity Management |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |