This randomized, prospective, multicenter, open-label study was designed to test whether a topical, electrolyzed, superoxidized solution (Microcyn Rx) is a safe and effective treatment for mildly infected diabetic foot ulcers.
Sixty-seven patients with ulcers were randomized into three groups. Patients with wounds irrigated with Microcyn Rx alone were compared with patients treated with oral levofloxacin plus normal saline wound irrigation and with patients treated with oral levofloxacin plus Microcyn Rx wound irrigation. Patients were evaluated on day 3, at the end of treatment on day 10 (visit 3), and 14 days after completion of therapy for test of cure (visit 4).
In the intention-to-treat sample at visit 3, the clinical success rate was higher in the Microcyn Rx alone group (75.0%) than in the saline plus levofloxacin group (57.1%) or in the Microcyn Rx plus levofloxacin group (64.0%). Results at visit 4 were similar. In the clinically evaluable population, the clinical success rate at visit 3 (end of treatment) for patients treated with Microcyn Rx alone was 77.8% versus 61.1% for the levofloxacin group. The clinical success rate at visit 4 (test of cure) for patients treated with Microcyn Rx alone was 93.3% versus 56.3% for levofloxacin plus saline–treated patients. This study was not statistically powered, but the high clinical success rate (93.3%) and the P value (P = .033) suggest that the difference is meaningfully positive for Microcyn Rx–treated patients.
Microcyn Rx is safe and at least as effective as oral levofloxacin for mild diabetic foot infections. (J Am Podiatr Med Assoc 101(6): 484–496, 2011)
We investigated the validity of probe-to-bone testing in the diagnosis of osteomyelitis in a selected subgroup of patients clinically suspected of having diabetic foot osteomyelitis.
Between January 1, 2007, and December 31, 2008, inpatients and outpatients with a diabetic foot ulcer were prospectively evaluated, and those having a clinical diagnosis of foot infection and at least one of the osteomyelitis clinical suspicion criteria were consecutively included in this study.
Sixty-five patients met the inclusion criteria and were prospectively enrolled in the study. Forty-nine patients (75.4%) were hospitalized, and the remaining 16 (24.6%) were followed as outpatients. Osteomyelitis was diagnosed in 39 patients (60.0%). Probe-to-bone test results were positive in 30 patients (46.1%). The positive predictive value for the probe-to-bone test was fairly high (87%), but the negative predictive value was only 62%. The sensitivity and specificity of the test were 66% and 84%, respectively. White blood cell counts and mean C-reactive protein levels did not statistically significantly differ between groups. However, erythrocyte sedimentation rates greater than 70 mm/h reached statistical significance between groups. Wound area and depth were not found to be statistically significantly different between groups.
Positive probe-to-bone test results and erythrocyte sedimentation rates greater than 70 mm/h provide some support for the diagnosis of diabetic foot osteomyelitis, but it is not strong; magnetic resonance imaging or bone biopsy will probably be required in cases of doubt. (J Am Podiatr Med Assoc 102(5): 369–373, 2012)
Although total-contact cast (TCC) systems are considered the gold standard for off-loading plantar ulcers, less than 6% of patients with diabetic foot ulcers receive them due to negative perceptions of special technique requirements and time investment in their application and removal. We compared the ease of use and casting time of four TCC systems.
Four novice casters applied each of the four TCC systems three times using the manufacturer's written instructions for cast application and removal of each cast type. For each TCC system, casters also provided ratings of quality and effectiveness, their level of confidence in applying each system, and overall ease of use.
The time to complete the first application of each cast type was not different among TCC systems. However, by the third application, TCC-EZ had a significantly faster application time than the other three TCC systems. In addition, TCC-EZ was considered better overall in packaging and instructions, quality of cast components, and casting method than the other TCC systems. Half of the casters rated TCC-EZ and MedE-Kast as the easiest to apply after the third and final trial, and TCC-EZ and MedE-Kast were rated as being the cast chosen to use in the casters' clinical practices.
One of the obstacles to use of TCC systems, despite being recognized as the gold standard of off-loading, is the perception of a prolonged learning curve on application. This study demonstrated that TCC-EZ can be applied by novice casters in less than 14 minutes after their third application experience.
Background: We sought to study the impact of foot complications on 10-year mortality independent of other demographic and biological risk factors in a racially and socioeconomically diverse managed-care population with access to high-quality medical care.
Methods: We studied 6,992 patients with diabetes in Translating Research Into Action for Diabetes (TRIAD), a prospective observational study of diabetes care in managed care. Foot complications were assessed using administrative claims data. The National Death Index was searched for deaths across 10 years of follow-up (2000-2009).
Results: Charcot's neuro-osteoarthropathy and diabetic foot ulcer with debridement were associated with an increased risk of mortality; however, the associations were not significant in fully adjusted models. Lower-extremity amputation (LEA) was associated with an increased risk of mortality in unadjusted (hazard ratio [HR], 3.21; 95% confidence interval [CI], 2.50–4.12) and fully adjusted (HR, 1.84; 95% CI, 1.28–2.63) models. When we examined the associations between LEA and mortality stratified by sex and race, risk was increased in men (HR, 1.96; 95% CI, 1.25–3.07), Hispanic individuals (HR, 5.17; 95% CI, 1.48–18.01), and white individuals (HR, 2.18; 95% CI, 1.37–3.47). In sensitivity analyses, minor LEA tended to increase the risk of mortality (HR, 1.48; 95% CI, 0.92–2.40), and major LEA was associated with a significantly higher risk of death at 10 years (HR, 1.89; 95% CI, 1.18–3.01).
Conclusions: In this managed-care population with access to high-quality medical care, LEA remained a robust independent predictor of mortality. The association was strongest in men and differed by race.
Topical Application of a Gentamicin-Collagen Sponge Combined with Systemic Antibiotic Therapy for the Treatment of Diabetic Foot Infections of Moderate Severity
A Randomized, Controlled, Multicenter Clinical Trial
The aim of this pilot study was to determine the safety and potential benefit of adding a topical gentamicin-collagen sponge to standard of care (systemic antibiotic therapy plus standard diabetic wound management) for treating diabetic foot infections of moderate severity.
We randomized 56 patients with moderately infected diabetic foot ulcers in a 2:1 ratio to receive standard of care plus the gentamicin-collagen sponge (treatment group, n = 38) or standard of care only (control group, n = 18) for up to 28 days of treatment. Investigators performed clinical, microbiological, and safety assessments at regularly scheduled intervals and collected pharmacokinetic samples from patients treated with the gentamicin-collagen sponge. Test of cure was clinically assessed 14 days after all antibiotic therapy was stopped.
On treatment day 7, we noted clinical cure in no treatment patients and three control patients (P = .017). However, for evaluable patients at the test-of-cure visit, the treatment group had a significantly higher proportion of patients with clinical cure than did the control group (22 of 22 [100.0%] versus 7 of 10 [70.0%]; P =.024). Patients in the treatment group also had a higher rate of eradication of baseline pathogens at all visits (P ≤ .038) and a reduced time to pathogen eradication (P < .001). Safety data were similar for both groups.
Topical application of the gentamicin-collagen sponge seems safe and may improve clinical and microbiological outcomes of diabetic foot infections of moderate severity when combined with standard of care. These pilot data suggest that a larger trial of this treatment is warranted. (J Am Podiatr Med Assoc 102(3): 223-232, 2012)
Fifteen percent of individuals with diabetes will likely develop foot ulcers in their lifetime, and approximately 15% to 20% of these ulcers are estimated to result in lower extremity amputation. Techniques to prevent lower extremity amputation range from the simple but often neglected foot inspection to complicated vascular and reconstructive foot surgery. Appropriate management can prevent and heal diabetic foot ulcers, thereby greatly decreasing the amputation rate and medical care costs. Prevention is the key to treatment. The author discusses general guidelines for foot screening and identifies three specific goals for prevention of amputation: 1) identification of at risk individuals needing prevention and the specific factors placing them at risk; 2) protection of the foot against the adverse effects of external forces (pressure, friction, and shear); and 3) reduction of the incidence of diabetic foot ulcers through educational programs.
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.
INTRODUCTION AND OBJECTIVES: The benefits of using amniotic tissue in skin regeneration are well documented. Today, cryopreservation technology allows for better availability and maintenance of mesenchymal stem cells. This is of particular interest in treating the diabetic foot ulcer as this population has fewer mesenchymal stem cells. The objective of this case series investigation was to compare the efficacy of cryopreserved human amniotic stem cells in treating foot wounds of different etiologies. We will present data and case photos for a diabetic foot ulcer, venous leg ulcer, arterial ankle ulcer, and a pyoderma gangrenosum ulcer
METHODS: Cryopreserved human amniotic stem cell grafts were applied to patients with chronic ulcers of different etiologies that had been subjected to at least 4 weeks of standard wound care and did not show adequate clinical progress. Wound area was recorded and photographed on weekly basis. Area reduction was charted over time and the results of each individual case were compared to one another.
RESULTS: All ulcers displayed results that well exceeded the established parameters of weekly healing rates for effective wound treatment modalities.
â€¢ Pyoderma gangrenosum displayed the poorest response to treatment. However, it is worth noting that the patient was not compliant in the prescribed adjunctive treatment regimen but managed to achieve 64% wound reduction.
â€¢ All ulcers showed the largest appreciable amount of healing in both total area reduction and week-to- week closure percentage after the first application.
CONCLUSIONS: Cryopreserved human amniotic stem cell grafts can aid in the decreasing the time to closure of various types of lower extremity ulcerations. The therapy is a clinically viable option for physicians to consider when formulating a treatment plan for a patient with an ulcer.
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.