The Veterans Administration added TransCu O2® to its supply schedule in 2012. My colleagues and I conducted an unpublished retrospective study over a period of 16 months at a VA hospital to determine the safety and efficacy of using continuous diffusion of oxygen via the TransCu O2® in the treatment of lower extremity ulcerations that were difficult to heal (the average age of the wound at start of continuous diffusion of oxygen was almost four months). We typically begin using advanced wound therapies much earlier than four months. However, with continuous diffusion of oxygen being a new therapy in our treatment regimen, we initially tried it after the wounds were not responsive to other advanced therapies with which we were familiar.
After excluding four patients for significant non-adherence and four patients to follow-up, 25 patients were included in the study. We used continuous diffusion of oxygen both as an adjunctive therapy and as a solitary treatment in an outpatient wound care setting. The majority of wounds (22 of 25) were Wagner grade 1 ulcers on the foot, ankle, or leg with granular wound bases. Twenty-two out of 25 patients had diabetes. The patients presented on a weekly basis on average for evaluation, offloading, dressing changes and sharp debridement.
The research parameters consisted of the duration of treatment, whether the wound healed (full closure), patient adherence, wound size, percent improvement in wound size, age of wound at start of use, hemoglobin A1c level where applicable, other therapies utilized, significant comorbidities and wound locations.
Seventeen of 25 patients experienced complete wound healing, a 68 percent healing rate. Of the 17 patients who healed (closed), all had diabetes with an average 7.9 hemoglobin A1c (Table 1). The average healing time was 7 weeks with an average wound size of 6.1 cm2. Thirteen patients had concomitant advanced tissue application: 6 with Neox (Amniox Medical), two with Dermagraft (Organogenesis), two with Apligaf (Organogenesis) and three with Grafix (Osiris Therapeutics).
These 13 patients had an average healing time of eight weeks. The four patients that healed with continuous diffusion of oxygen therapy alone had an average healing time of four weeks.
Out of the 25 patients, eight did not heal. Five of these patients had diabetes and the remaining three had ulcers due to PVD rather than diabetes. Three of these patients had no improvement during treatment, three had minimal improvement (5 to 30 percent) and two had moderate improvement (60 to 90 percent). The average wound size (8.5 cm2) was not dissimilar from those that healed. The average duration of continuous diffusion of oxygen therapy was just over nine weeks and we determined that failed therapy was a wound that had not decreased in size over the course of at least three weeks. Three patients went to another facility for HBOT as they had already failed multiple wound healing modalities. Two patients had leg amputations due to severe PVD.
Of interest is that of the three patients who were lost to follow up, two experienced significant wound closure. One was essentially healed (more than 99 percent) and did not return. The other patient’s wound had closed 89 percent before the patient was hospitalized for reasons unrelated to the wound.
While these data support the use of continuous diffusion of oxygen as an adjunctive treatment, the fact that four patients healed with oxygen therapy alone suggests that clinicians may consider using this treatment as a monotherapy for lower extremity ulcerations. It is interesting to note that the closure results for continuous diffusion of oxygen reported here (68 percent) appear to be repeatable in that they are similar to those reported for toe ulcers (74 percent for 20 patients), as well as those reported in an online registry for diabetic foot ulcers (77 percent for 201 patients).12,13 Similar comparisons are evident for high patient adherence to the therapy, with 89 percent adherence in this study versus 95 and 89 percent adherence reported in the other studies, supporting the ease of use of the therapy.12,13