Objectives: Perfusion and blood oxygen levels are frequently insufficient in patients with hard-to-heal wounds due to poor circulation, vascular disruption and vasoconstriction, reducing the wound's capacity to heal. This study aimed to investigate the effect of topical oxygen on healing rates in patients with hard-to-heal diabetic foot ulcers (DFUs) (i.e., non-responsive over four weeks). Method: This multicentre, open-label, community-based randomised clinical trial compared standard care (SOC) with or without continuous topical oxygen therapy (TOT) for 12 weeks in patients with DFUs or minor amputation wounds. SOC included debridement, offloading with total contact casting (TCC) and appropriate moisture balance. Primary endpoints were the number of patients to achieve complete wound closure and percentage change in ulcer size. Secondary endpoints were pain levels and adverse events. Results: For the study, 145 patients were randomised with index ulcers graded Infectious Diseases Society of America (IDSA) 1 or 2, or Wagner 1 or 2. In the intention-to-treat analysis, 18/64 (28.1%) patients healed in the SOC group at 12 weeks compared with 36/81 (44.4%) in the SOC plus TOT group (p=0.044). There was a statistically significant reduction in wound area between the groups: SOC group mean reduction: 40% (standard deviation (SD) 72.1); SOC plus TOT group mean reduction: 70% (SD 45.5); per protocol p=0.005). There were no significant differences in changes to pain levels or adverse events. Conclusion: This study suggests that the addition of TOT to SOC facilitates wound closure in patients with hard-to-heal DFUs.

Management of chronic wounds in the outpatient setting is quite challenging. The extensive co-morbid medical problems of the chronically ill patient along with the complexities of the wound bed and its biochemical environment has led to a plethora of patients with poor wound healing. This ever increasing population is a challenge for the wound care practitioner and cost to the health care system and patient. Increased wound chronicity has promulgated the use of advanced wound care products, including Living Skin Substitutes (LSS), in an attempt to obtain wound closure, and ultimately both physiological and functional healing.(1-3) In the outpatient setting, it is evident that the efficacy of the LSS varies widely depending on the patient type with some patients responding quite favorably while others who do not achieve healing despite repeated applications of LSS. This case series demonstrates that a systematic method of wound bed preparation prior to the application of LSS improved healing outcomes. The entire wound bed preparation protocol included autolytic, non-selective, and sharp-selective debridement, if deemed appropriate, followed by the weekly application of a pure native collagen. The wound bed preparation protocol was completed prior to LSS application. This case series presents evidence supporting the application of a 100% native collagen dressing to wound bed prior to the final step of LSS utilization.

Introduction. Diabetic foot ulcer is a complex wound that requires considerable effort to restart a stalled healing process. In this study, a TABCT product was used in a point-of-care setting to treat DFUs by reconstructing the ECM and adjusting intricate phenotypes and mechanisms of mediators to progress towards complete healing. The mechanism of action consists of reconstruction of the ECM, which protects the wound area from further destruction while it incorporates into the ulcer to promote granulation over exposed vital structures (ie, tendons, bone, and neurovascular structures). Objective. The authors evaluated the efficacy of the TABCT product in the management of DFUs. Materials and Methods. Study participants were wound care patients in hospitals and clinics across the United States and Israel as part of a registry study (ClinicalTrials.gov: NCT04699305). Twenty-nine patients age 18 years or older with chronic DFUs were included. A blood clot was created using the patient’s own peripheral blood in a point-of-care setting. An 18-mL blood sample was drawn from the patient and incorporated with calcium gluconate and kaolin to form a clot. Efficacy and superiority levels in PAR at week 4 and week 12 over the SOC treatment were established using the Agresti-Coull confidence interval. Results. Treatment of DFUs using the TABCT product resulted in 22 patients (75.86%) achieving 50% PAR at week 4 and showed superiority when compared with SOC data in previously published studies. Complete closure was achieved in 28 wounds (95%) at week 12. Conclusion. In the current study, TABCT exhibited superiority over SOC treatment and provided granulation over vital structures with a reduction in overall wound size in a timely manner via incorporation and stimulation of the body’s own healing capabilities.