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To evaluate continuous diffusion of oxygen therapy (CDO) on cytokines, perfusion, and bacterial load in diabetic foot ulcers we evaluated 23 patients for 3 weeks. Tissues biopsies were obtained at each visit to evaluate cytokines and quantitative bacterial cultures. Perfusion was measured with hyperspectral imaging and transcutaneous oxygen. We used paired T tests to compare continuous variables and independent T tests to compare healers and nonhealers. There was an increase from baseline to week 1 in TGF-β (P = .008), TNF-α (P = .014), VEGF (P = .008), PDGF (P = .087), and IGF-1 (P = .058); baseline to week 2 in TGF-β (P = .010), VEGF (P = .051), and IL-6 (P = .031); and baseline to week 3 with TGF-β (P = .055) and IL-6 (P = .054). There was a significant increase in transcutaneous oxygen after 1 week of treatment on both medial and lateral foot (P = .086 and .025). Fifty-three percent of the patients had at least a 50% wound area reduction (healers). At baseline, there were no differences in cytokines between healers and nonhealers. However, there was an increase in CXCL8 after 1 week of treatment (P = .080) and IL-6 after 3 weeks of treatment in nonhealers (P = .099). There were no differences in quantitative cultures in healers and nonhealers., (© 2020 The Authors. International Wound Journal published by Medicalhelplines.com Inc (3M) and John Wiley & Sons Ltd.)

We compared cellular viability between cryopreserved and lyopreserved amniotic membranes and clinical outcomes of the lyopreserved construct in a prospective cohort study of 40 patients with neuropathic foot ulcers. Patients received weekly application of lyopreserved membrane for 12 weeks with standard weekly debridement and offloading. We evaluated the proportion of foot ulcers that closed, time to closure, closure trajectories, and infection during therapy. We used chi-square tests for dichotomous variables and independent t-tests for continuous variables with an alpha of α = .10. Cellular viability was equivalent between cryo- and lyopreserved amniotic tissues. Clinically, 48% of subjects' wounds closed in an average of 40.0 days. Those that did not close were older (63 vs 59 years, P = .011) and larger ulcers at baseline (7.8 vs 1.6 cm 2 , P = .012). Significantly more patients who achieved closure reached a 50% wound area reduction in 4 weeks compared with non-closed wounds (73.7% vs 47.6%, P = .093). There was no difference in the slope of the wound closure trajectories between closed and non-closed wounds (0.124 and 0.159, P = .85), indicating the rate of closure was similar. The rate of closure was 0.60 mm/day (SD = 0.47) for wounds that closed and 0.50 mm/day (SD = 0.58) for wounds that did not close (P = .89)., (© 2020 The Authors. International Wound Journal published by Medicalhelplines.com Inc (3M) and John Wiley & Sons Ltd.)

Aim: To compare the efficacy of Negative Pressure Wound Therapy (NPWT) with and without irrigation with 0.1% polyhexanide-betaine., Methods: We randomized 150 subjects in a 16-week RCT to compare healing in patients with diabetic foot infections. NPWT delivered at 125 mm Hg continuous pressure. NPWT-I were administered at 30 cc per hour., Results: There were no differences clinical treatment or outcomes: wound area after surgery (18.5 ± 19.0 vs. 13.4 ± 11.1 cm2, p = 0.50), duration of antibiotics (39.7 ± 21.0 vs. 38.0 ± 24.6 days, p = 0.40), number of surgeries (2.3 ± 0.67 vs. 2.2 ± 0.59, p = 0.85), duration of NPWT (148.1 ± 170.4 vs. 114.5 ± 135.1 h, p = 0.06), healed wounds (58.7% vs. 60.0%, p = 0.86), time to healing (56.3 ± 31.7 vs. 50.7 ± 27.8, p = 0.53), length of stay (13.8 ± 6.4 vs. 14.5 ± 11.2 days, p = 0.42), re-infection (20.0% vs. 22.7%, p = 0.69, and re-hospitalization (17.3% vs. 18.7, p = 0.83)., Conclusions: The addition of irrigation to NPWT did not change clinical outcomes in patients with diabetic foot infections., Clinical Trial Number: NCT02463487, ClinicalTrials.gov., Competing Interests: Declaration of competing interest LAL has research funding from Cardinal Health, KCI, EO2 Concepts, Osiris Therapeutics, Avazzia, Pluristem Therapeutics, Inc., and consulting agreements with EO2 Concepts, Cardinal Health, Bayer, Medline Industries, Boehringer Ingelheim, Medimmune. KED has research funding from Cardinal Health, Avazzia, EO2 Concepts, MedImmune, Pluristem Therapeutics Inc., Osiris Therapeutics, and consulting agreements with EO2 Concepts, Cardinal Health, Bayer, Medline Industries, Boehringer Ingelheim, Medimmune. JL has research funding from Cardinal Health, Avazzia, KCI, EO2, Osiris Therapeutics, MedImmune, Pluristem Therapeutics, Inc. DF has research funding from the National Institute of Allergy and Infectious Diseases. KB has research funding from the American Diabetes Association. OKO has research funding from the American Diabetes Association. PAC has research funding from the American Diabetes Association, Cardinal Health, EO2 Concepts, Osiris Therapeutics, Avazzia, Pluristem Therapeutics, Inc. This publication was published as an abstract at the Diabetic Foot Australia meeting 2019, Brisbane, Australia 08–10/Sep/2019., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Aim: The objective was to estimate the cost of care associated with two negative pressure wound therapy (NPWT) technologies used to treat patients admitted to the hospital with moderate-to-severe foot infections. Materials & methods: A decision tree simulation model was developed to estimate the hospital costs associated with two different NPWT technologies: Cardinal Health™ PRO (NPWT-C) and V.A.C. ULTA™ (NPWT-K). Clinical data were obtained from a previously completed single-site prospective trial. One-way and probabilistic sensitivity analyses were performed to gauge the robustness of the results. Results: The total expected per-patient costs were US$41,206 (SD: US$8,194) for NPWT-C and US$44,439 (SD: US$8,963) for NPWT-K. Conclusion: This study found that NPWT-C was expected to minimize the total costs over the episode of treatment. Larger and more clinically diverse studies are recommended to confirm these findings.

The aim of this study is to evaluate serum biomarkers to monitor high-risk patients for reinfection of bone. Thirty-five patients were prospectively enrolled with moderate to severe diabetic foot infections with suspicion of osteomyelitis. Bone samples were obtained for culture and histology. Clinical characteristics and outcomes of patients were compared using χ 2 square test. Biomarkers (white blood cell count, erythrocyte sedimentation rate, c-reactive protein, procalcitonin, interleukin-6, interleukin-8, and monocyte chemoattractant protein 1) were assessed at baseline, 3, and 6 weeks after treatment initiation and evaluated for correlation with reinfection of bone. After 6 weeks of antibiotic treatment, ESR at 73.5 mm/h (sensitivity 62.5%, specificity 100%, area under the receiver operating characteristic (AUROC) 0.7839, 95% CI 0.54-1.00, P < .01) and IL-8 at 15.09 mg/dL (sensitivity 42.9%, specificity 92.0% AUROC 0.6286, 95% CI 0.36-0.90, P = .0496) were associated with reinfection of bone. An increase in IL-8 from week 0 to 6 >0.95 mg/dL was associated with reinfection (sensitivity 71%, specificity 72% AUROC 0.7057, 95% CI 0.49-0.92, P = .04). An ESR change from week 0-6 of -16.5% (sensitivity 71.4%, specificity 86.4% AUROC 0.7403, 95% CI 0.48-1.00, P = .02), CRP (-)74.4% (sensitivity 66.7%, specificity 91.3% AUROC 0.7174, 95% CI 0.40-1.00, P = .04), IL-6 (-)49.9% (sensitivity 71.4%, specificity 76% AUROC 0.7371, 95% CI 0.47-1.00, P = .04), and IL-8 29% (sensitivity 85.7%, specificity 56.0% AUROC of 0.7343, 95% CI 0.54-0.93, P = .048) were associated with increased risk of reinfection. Pilot data suggest that serum biomarkers (ESR, IL8 and IL6, MCP-1) may be correlated with developing osteomyelitis and could be used to monitor high-risk patients for reinfection., (© 2020 by the Wound Healing Society.)

The aim of this study was to compare the efficacy of different negative pressure wound therapy (NPWT) devices and NPWT with and without simultaneous irrigation in patients admitted to hospital with moderate and severe foot infections. Ninety patients were randomized in a 12-week prospective, randomized noninferiority trial to compare wound healing in patients with moderate and severe infected foot wounds treated with NPWT after surgery. Inclusion criteria included ABI > 0.5 or toe pressures >30 PVR/mmHg, >18 years of age and exclusion included active Charcot arthropathy, collagen vascular disease, HIV, and hypercoagulable state. We compared two different traditional devices, NPWT-K (KCI, VAC Ulta) and NPWT-C (Cardinal, PRO), and NPWT-I with saline irrigation (Cardinal, PRO). All patients had therapy delivered at 125 mmHg continuous pressure. In patients who received simultaneous saline irrigation (NPWT-I), the administration rate was 15 ml per hour. The primary outcome was the proportion of healed wounds in 12 weeks. Secondary outcomes included surgical wound closure, number of surgeries, length of stay, and time to wound healing. Continuous data was presented as mean ± standard deviation. Analysis of variance was used to compare continuous variables and chi-square to compare dichotomous variables with an alpha of 0.05. There were no differences in outcomes among NPWT-I, NPWT-C, and NPWT-K groups in proportion of healed wounds (63.3%, 50.0%, 46.7% p = 0.39), surgical wound closure (83.3%, 80.0%, 63.3%, p = 0.15), number of surgeries (2.0 ± 0.49, 2.4 ± 0.77, 2.4 ± 0.68, p = 0.06), length of stay (16.3 ± 15.7, 14.7 ± 7.4, 15.3 ± 10.5 days, p = 0.87), time to wound healing (46.2 ± 22.8, 40.9 ± 18.8, 45.9 ± 28.3 days, p = 0.78). We did not identify any significant differences in clinical outcomes or adverse events between patients treated with different NPWT devices or NPWT with and without irrigation., (© 2019 The Authors. Wound Repair and Regeneration published by Wiley Periodicals, Inc. on behalf of by the Wound Healing Society.)

To compare the incidence of osteomyelitis based on different operational definitions using the gold standard of bone biopsy, we prospectively enrolled 35 consecutive patients who met the criteria of ≥21 years of age and a moderate or severe infection based on the Infectious Diseases Society of America classification. Bone samples were obtained from all patients by percutaneous bone biopsy or intraoperative culture if the patient required surgery. Bone samples were analyzed for conventional culture, histology, and 16S ribosomal RNA genetic sequencing. We evaluated 5 definitions for osteomyelitis: 1) traditional culture, 2) histology, 3) genetic sequencing, 4) traditional culture and histology, and 5) genetic sequencing and histology. There was variability in the incidence of osteomyelitis based on the diagnostic criteria. Traditional cultures identified more cases of osteomyelitis than histology (68.6% versus 45.7%, p = .06, odds ratio [OR] 2.59, 95% confidence interval [CI] 0.98 to 6.87), but the difference was not significant. In every case that histology reported osteomyelitis, bone culture was positive using traditional culture or genetic sequencing. The 16S ribosomal RNA testing identified significantly more cases of osteomyelitis compared with histology (82.9% versus 45.7%, p = .002, OR 5.74, 95% CI 1.91 to 17.28) and compared with traditional cultures but not significantly (82.9% versus 68.6%, p = .17, OR 2.22, 95% CI 0.71 to 6.87). When both histology and traditional culture (68.6%) or histology and genetic sequencing cultures (82.9%) were used to define osteomyelitis, the incidence of osteomyelitis did not change. There is variability in the incidence of osteomyelitis based on how the gold standard of bone biopsy is defined in diabetic foot infections., (Copyright © 2018 the American College of Foot and Ankle Surgeons. Published by Elsevier Inc. All rights reserved.)

This study sought to evaluate the effectiveness of the inflammatory markers, erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP), in monitoring treatment of osteomyelitis in the diabetic foot. We screened 150 charts of patients admitted to our hospital with diabetic foot osteomyelitis (DFO), confirmed by positive results of bone culture and/or histopathology. We included patients who had an initial ESR/CRP within 72 hours of admission and two reported follow-up values. We dichotomised patients based on the outcomes wound healing, re-infection, recurrent ulceration, re-hospitalisation, additional surgery, re-amputation and death, all within 12 months, and analysed the trajectories of the markers over time. Our primary outcome, DFO remission, was defined as wound healing within 12 months of follow-up without re-infection. We included 122 subjects; 65 patients (53·3%) had a combination of positive culture and histopathology. Factors associated with DFO remission (n = 46) were a lower white blood count (WBC) at admission (P = 0·006) and a higher glomerular filtration rate (GFR, P = 0·049). Factors associated with healing were a lower WBC (P = 0·004), a higher GFR (P = 0·01), longer wound duration before admission (P = 0·01), location of the ulcer on the great toe (P = 0·01) and higher glycated haemoglobin (P = 0·03). Logistic regression analysis demonstrated no associations between DFO remission and other variables collected. Trajectories of the inflammatory markers showed an association between stagnating values of ESR and CRP and poor clinical outcomes. In this study population, the trajectories of both ESR and CRP during 12 months follow-up suggest a predictive role of both inflammatory markers when monitoring treatment of DFO., (© 2016 Medicalhelplines.com Inc and John Wiley & Sons Ltd.)

Background: This study was designed to compare two approaches to negative-pressure wound therapy: 125-mmHg pressure with a polyurethane foam dressing and 75-mmHg pressure with a silicone-coated dressing., Methods: Forty patients with diabetic foot wounds, after incision and drainage or amputation for infection, were assigned randomly to negative-pressure wound therapy with 75-mmHg continuous pressure with a silicone-covered dressing (75-mmHg group) or 125-mmHg with a polyurethane foam dressing (125-mmHg group) for up to 4 weeks or until surgical closure., Results: There was no difference in the proportion of wounds that were closed surgically (75-mmHg group, 50 percent; 125-mmHg group, 60 percent), wounds that demonstrated 50 percent wound area reduction (75-mmHg group, 65 percent; 125-mmHg group, 80 percent), or wounds that demonstrated 50 percent wound volume reduction after 4 weeks of therapy (75-mmHg group, 95 percent; 125-mmHg group, 90 percent)., Conclusion: The authors' results suggest that there was no difference in outcomes in wounds treated with low pressure (75 mmHg) with a silicone-coated interface and high pressure (125 mmHg) with a polyurethane foam interface., Clinical Question/level of Evidence: Therapeutic, II.