Evaluation of Tissue Oxygenation and the Progression of Wound Healing: A Prospective Cohort Evaluating the Underlying Mechanisms of Transdermal Cutaneous Oxygen Therapy on Chronic Lower Extremity Ulcers

The objective of this study is to better understand the underlying mechanism of Continuous Diffusion of Oxygen (CDO) and to demonstrate its clinical effectiveness by initially identifying biomarkers in patients with chronic lower extremity ulcers, and then observing the effect of CDO on the wound biomarkers as wound healing progresses. Due to our current understanding of the hypoxic conditions in chronic wound healing, we hypothesize that the effects of CDO involve both the reduction of proteases from inflammatory cells and the facilitation of angiogenesis to prevent hypoxia. Five patients with chronic lower extremity ulcers will be recruited for this pilot study. All of the patients will receive CDO and the progression of wound healing will be studied over a 12 week period by evaluating the following 5 aspects of the chronic ulcers: healing status, changes in wound bioburden, identification of wound relevant proteins and pathways, gene expression changes in the wound bed and histological changes of the wound. This study is being conducted at the Rosalind Franklin University, Chicago, IL.