Continuous Diffusion of Oxygen (CDO) Treatment for Chronic Wounds

The purpose of this project is to describe healing outcomes in the VA for the treatment of chronic ulcers using Continuous Diffusion of Oxygen therapy (CDO). CDO is a form of moist wound therapy whereby pure oxygen is added within the moist wound therapy dressing using a portable system. The system used for this study will be the TransCu O2 System, which consists of a handheld oxygen generator, a cannula for delivering the oxygen to the wound and moist wound therapy dressings. In other words, CDO is moist wound therapy with added pure oxygen supplied continuously. Chronic wounds are defined as those that do not follow the normal healing process and show no signs of healing in 4 weeks. Changes in wound size will be analyzed before and after treatment with CDO. The time to bring wounds to full closure will also be examined. The impact of the use of concomitant tissue therapies, such as skin substitutes or tissue matrices, will be assessed. These outcomes will be compared to outcomes reported for the use of other advanced modalities, such as negative pressure wound therapy and skin grafts in peer-reviewed, published studies, as well as the Sponsor’s public registry of results. The goals of the project are: 1) to determine whether CDO therapy is superior or equivalent to other advanced treatment modalities, such as moist wound therapy alone, NPWT or skin grafts, currently used in the treatment of chronic wounds; and 2) to compare the real-world application of CDO therapy to the results from controlled, randomized clinical trials. The study was conducted at the Central Texas Veteran’s Healthcare Administration, Temple, TX.