Short summary

Chronic leg ulcers are wounds that fail to undergo the normal stages of wound healing resulting in an abnormal and inflammatory wound microenvironment. When surgical treatments aimed at improving wound healing conditions fail, patients are left with only conservative wound care which can lead to wound healing occurring over several years. Many preclinical studies and a few clinical studies have shown that use of stem cells can accelerate wound healing. The most abundant and convenient source of these cells are from the adipose tissue. These cells can easily be isolated, from adipose tissue obtained from liposuction, in automated closed systems enabling autologous cell therapy as a same day procedure. In this study we aim to examine effectiveness of autologous adipose-derived regenerative cells for accelerating wound healing in chronic leg ulcers in a pragmatic randomized controlled trial.

Rationale

Many patients with chronic leg ulcers are left with no other treatment options besides conservative wound care. This results in wound healing over several years or maybe never. There is an urgent need for more treatment options for these patients. Stem cell therapy has emerged as a potential candidate as these cells can secrete a wide variety of growth factors and cytokines promoting angiogenesis and modulating the inflammatory response. Adipose tissue is most abundant in these cells and can easily be harvested and isolated using liposuction and closed automated systems. At Odense University Hospital we have all necessary facilities to offer this treatment and the patients are treated at the University Center for Wound Healing at the Department of Plastic Surgery, OUH. We therefore set out to examine the effectiveness of this treatment modality in a pragmatic randomized controlled trial. We aim to include 30 patients evenly distributed between standard of care or standard of care + autologous stem cell therapy obtained from their own adipose tissue. Patients will be followed for 6 months and wound size will be evaluated every 2 weeks. 

Description of the cohort

Patients with chronic leg ulcers with arteriovenous origin are included in this study. All patients are included from the University Center for Wound Healing at the Department of Plastic Surgery, OUH. 

Data and biological material

Patients undergoing experimental treatment with autologous adipose-derived regenerative cells will have a small part of their isolated cells saved in a Biobank.

Clinical data is saved in the electronic case files.

Wound size is evaluated photographically and saved in SharePoint. 

Collaborating researchers and departments

Department of Plastic Surgery, Odense University Hospital

• Professor Jens Ahm Sørensen, PhD
• Anne Marie Nielsen

Department of Clinical Biochemistry and Pharmacology, Odense University Hospital

• Professor Søren Paludan Sheikh
• Senior researcher Charlotte Harken Jensen
• Clincal associate professor Ditte Caroline Andersen, PhD