Vaporous Hyperoxia Therapy (VHTTM), a patented FDA-510 (k) cleared technology, is an adjunct therapy used in conjunction with standard wound care (SWC). VHT is said to improve the health of wounded tissue by administering a low-frequency, non-contact, non-thermal ionic anti-microbial hydrating mist alternating with concentrated topical oxygen therapy (TOT). VHT was used to treat 36 subjects with chronic diabetic foot ulcers (DFUs) that were previously treated unsuccessfully with SWC. The average age of DFU in the study was 11 months old and the average size was over 3 cm2. Wounds were either Wagner Grade 2 or 3 and most commonly on the plantar surface around the midfoot. Treatment consisted of twice weekly applications of VHT and wound debridement. Subjects were followed to wound closure, 20 weeks, or 40 treatments, whichever came first. The combination of SWC and VHT in the group that met and maintained compliance throughout the study period achieved an 83% DFU closure rate within a 20-week time period. The average time for DFU closure in this study was 9.4 weeks. Historical analysis of SWC shows a 30.9% healing rate of all wounds, not differentiating chronic wounds. Accordingly, SWC/VHT increases chronic diabetic foot ulcer healing rates by 2.85 times compared with SWC alone. The purpose of this study was two-fold: first, to observe the effect of VHT on healing rates and time to healing in previously nonhealing DFUs and second, to compare VHT with SWC, TOT and hyperbaric oxygen therapy (HBOT) and ultrasound therapies.
BACKGROUND: Multiple organizations have issued guidelines to address the prevention, diagnosis and management of diabetic foot ulcers. These guidelines are based on evidence review and expert opinion. <p>METHODS: Literature review was conducted and guidelines were reviewed to identify consensus (or lack thereof) on the nature of these recommendations, the strength of the recommendations and the level of evidence.</p> <p>RESULTS: Most guidelines were not based on highest level of evidence (randomized controlled trials). A listing of recommendations for prevention, diagnosis and management was created with evidence basis for all recommendations.</p> <p>CONCLUSIONS: Areas for future research were identified among recommendations based on minimal evidence, areas of controversy, or in areas of clinical care without recommendations.</p>
BACKGROUND:Diabetic foot ulceration is a severe complication of diabetes characterized by chronic inflammation and impaired wound healing. This study aims to evaluate the effect of a medical device gel based on Adelmidrol + Trans traumatic acid in the healing process of diabetic foot ulcers. METHODS: Thirty-seven diabetic patients with foot ulcers of mild/moderate grade were treated with the gel applied daily for 4 weeks on the affected area. The following parameters were evaluated at baseline and weekly: a) wound area, measured drawing a map of the ulcer then calculated with Photoshop6 tools, b) clinical appearance of the ulcer, assessed recording the presence/absence of dry/wet necrosis, infection, fibrin, neoepithelium, exudate, redness, granulation tissue. RESULTS: Topical treatment led to progressive healing of diabetic foot ulcers with a significant reduction of the wound area and an improvement in the clinical appearance of the ulcers. No adverse events treatment-related were observed. CONCLUSIONS: The results of this open-label study show the potential benefits of Adelmidrol + Trans traumatic acid topical administration to promote re-epithelialization of diabetic foot ulcers. Further studies need to confirm the observed results.
Background: Diabetic foot ulcers (DFUs) are main cause of hospitalizations and amputations in diabetic patients. Failure of standard foot care is the most important cause of impaired DFUs healing. Dakin's solution (DS; sodium hypochlorite) is a promising broad spectrum bactericidal antiseptic for DFUs management. Studies investigating the efficacy of using DS solution on DFUs healing process are scarce. Accordingly, this is the first evidence based randomized control trial study conducted to evaluate the effect of using diluted DS compared with the standard care in the management of infected DFUs. Methods: Randomized control trial study was conducted to assess the efficacy of DS in the management of infected DFUs. Patients were randomly distributed to control group (DFUs irrigated with normal saline) and intervention group (DFUs irrigated with 0.1% DS). Patients were followed for at least 24 weeks for healing, reinfection or amputations. In-vitro antimicrobial testing on DS was performed including determination of its minimum inhibitory concentration (MIC), minimum bactericidal concentration (MBC), minimum biofilm inhibitory concentration (MBIC), minimum biofilm eradication concentration (MBEC) and suspension test. Results: Replacing normal saline irrigation in DFU standard care with 0.1% DS followed by soaking the ulcer with commercial sodium hypochlorite (0.08 %) after patient discharge significantly improved ulcer healing (p< 0.001) and decreased number of amputations and hospitalizations (p< 0.001). The endpoint of death from any cause (RR 0.13; p = 0.029) and the amputation rate (RR 0.27; p<0.001) were also significantly reduced. The effect on ulcer closure (OR 11.9; p<0.001) was significantly enhanced in comparison to the control group. Moreover, DS irrigation for inpatients, significantly decreased bacterial load (p< 0.001), The in-vitro analysis results of DS were: MIC (1.44%), MBC (2.88%), MBIC (1.08%) and MBEC (2.87%). Conclusions: Compared with standard care, diluted DS (0.1%) was more effective in the management of infected DFUs. DS (0.1%) irrigation with debridement followed by standard care is a promising method in the management of infected DFUs.
The COVID-19 pandemic is driving significant change in the healthcare system and disrupting the best practices for diabetic limb preservation, leaving large numbers of patients without care. Patients with diabetes and foot ulcers are at increased risk for infections, hospitalization, amputations, and death. Podiatric care is associated with fewer diabetes-related amputations, ER visits, hospitalizations, length-of-stay, and costs. But podiatrists must mobilize and adopt the new paradigm of shifts away from hospital care to community-based care. Implementing the proposed Pandemic Diabetic Foot Triage System, in-home visits, higher acuity office visits, telemedicine, and remote patient monitoring can help podiatrists manage patients while reducing the COVID-19 risk. The goal of podiatrists during the pandemic is to reduce the burden on the healthcare system by keeping diabetic foot and wound patients safe, functional, and at home.
Background: While numerous studies suggest the benefit of electrical stimulation (E-Stim) therapy to accelerate wound healing, the underlying mechanism of action is still debated. In this pilot study, we examined the potential effectiveness of lower extremity E-Stim therapy to improve tissue perfusion in patients with diabetic foot ulcers (DFUs). Methods: Thirty-eight patients with DFUs were recruited. Participants underwent 60-minutes of active E-Stim therapy provided on acupuncture points above the level of the ankle joint using a bio-electric stimulation technology® (BEST) platform (Tennant Biomodulator® PRO). As primary outcome, changes in perfusion in response to E-Stim were assessed by measuring skin perfusion pressure (SPP) at baseline, 30-, and 60-min during therapy. In addition, retention was assessed 10-min post-therapy. As secondary outcome, tissue oxygen saturation (SatO2) was measured using a non-invasive near-infrared camera (Snapshot NIR, KENT Imaging Inc). Results: SPP increased in response to E-Stim therapy (p = 0.02) with maximum improvement observed at 60-min (11%, p = 0.007) compared to baseline. SPP reduced at 10-min post therapy, but remained higher than baseline (9%, p = 0.1). Magnitude of improvement at 60-min was negatively correlated with baseline SPP values (r = -0.45, p = 0.01) suggesting those with lower perfusion could benefit more from E-Stim therapy. Similar trends were observed for SatO2 with statistically significant improvement for a sub-sample (n=16) with moderate-severe peripheral arterial disease (Ankle brachial index < 0.8 or > 1.4). Conclusions: This study provides early results on the feasibility and effectiveness of E-Stim therapy to improve skin perfusion and SatO2. The magnitude of benefit is higher among those with poorer skin perfusion. Results also suggest the effects of E-Stim could be washed out after stopping therapy and thus regular daily application may be required for the effective benefit for wound healing.