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1. NATROX oxygen wound therapy for managing diabetic foot ulcers and complex or chronic non-healing wounds

NATROX oxygen wound therapy for managing diabetic foot ulcers and complex or chronic non-healing wounds NATROX oxygen wound therapy for managing diabetic foot ulcers and complex or chronic non-healing wounds Medtech innovation briefing Published: 17 March 2020 www.nice.org.uk/guidance/mib208 pathways Summary Summary • The technology technology described in this briefing is NATROX. It is used to treat chronic non-healing and complex wounds, including diabetic foot ulcers. • The innovative (...) that NATROX effectively treats a range of chronic wounds, and is more effective than standard care in people with grade 2 and grade 3 diabetic foot ulcers. © NICE 2020. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 1 of 10• Key uncertainties Key uncertainties around the evidence or technology are the small sample size of the randomised controlled trial and the heterogenous population in the larger observational studies. These limit

2020 National Institute for Health and Clinical Excellence - Advice

2. The Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification system predicts wound healing better than direct angiosome perfusion in diabetic foot wounds (Abstract)

with wound healing in diabetic foot ulcers (DFUs) treated by a multidisciplinary team. The aim of this study was to compare WIfI classification vs DP and pedal arch patency as predictors of wound healing in patients presenting with DFU and peripheral arterial disease.We performed a retrospective review of a prospectively maintained database of all patients with peripheral arterial disease presenting to our multidisciplinary DFU clinic who underwent angiography. An angiosome was considered directly (...) ), whereas DP (HR, 0.82; 95% CI, 0.55-1.21) and pedal arch grade (HR, 0.85; 95% CI, 0.70-1.03) were not.In our population of patients treated by a multidisciplinary diabetic foot service, the Society for Vascular Surgery WIfI classification system was a stronger predictor of diabetic foot wound healing than DP or pedal arch patency. Our results suggest that a measure of wound severity should be included in all future studies assessing wound healing as an outcome, as differences in patients' wound

2018 EvidenceUpdates

3. The Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification independently predicts wound healing in diabetic foot ulcers (Abstract)

The Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification independently predicts wound healing in diabetic foot ulcers Previous studies have reported correlation between the Wound, Ischemia, and foot Infection (WIfI) classification system and wound healing time on unadjusted analyses. However, in the only multivariable analysis to date, WIfI stage was not predictive of wound healing. Our aim was to examine the association between WIfI classification and wound (...) healing after risk adjustment in patients with diabetic foot ulcers (DFUs) treated in a multidisciplinary setting.All patients presenting to our multidisciplinary DFU clinic from June 2012 to July 2017 were enrolled in a prospective database. A Cox proportional hazards model accounting for patients' sociodemographics, comorbidities, medication profiles, and wound characteristics was used to assess the association between WIfI classification and likelihood of wound healing at 1 year.There were 310 DFU

2018 EvidenceUpdates

4. Re: The Effect of Foot Exercises on Wound Healing in Type 2 Diabetic Patients With a Foot Ulcer: A Randomized Control Study. J Wound Ostomy Continence Nursing. 2018;45(2):123-130. (Abstract)

Re: The Effect of Foot Exercises on Wound Healing in Type 2 Diabetic Patients With a Foot Ulcer: A Randomized Control Study. J Wound Ostomy Continence Nursing. 2018;45(2):123-130. 30260907 2019 10 03 2019 10 07 1528-3976 45 6 2018 Nov/Dec Journal of wound, ostomy, and continence nursing : official publication of The Wound, Ostomy and Continence Nurses Society J Wound Ostomy Continence Nurs Re: The Effect of Foot Exercises on Wound Healing in Type 2 Diabetic Patients With a Foot Ulcer (...) : A Randomized Control Study. J Wound Ostomy Continence Nursing. 2018;45(2):123-130. 492-493 10.1097/WON.0000000000000484 Dufour Émilie É Montréal, Canada. Duhoux Arnaud A eng Letter Comment United States J Wound Ostomy Continence Nurs 9435679 1071-5754 N J Wound Ostomy Continence Nurs. 2018 Mar/Apr;45(2):123-130 29521922 J Wound Ostomy Continence Nurs. 2018 Nov/Dec;45(6):495 30395122 Diabetes Mellitus, Type 2 Diabetic Foot Foot Ulcer Humans Ostomy Wound Healing 2018 9 28 6 0 2019 10 8 6 0 2018 9 28 6 0

2019 Journal of wound, ostomy, and continence nursing : official publication of The Wound, Ostomy and Continence Nurses Society Controlled trial quality: uncertain

5. Authors' Response to a Letter to the Editor Re: The Effect of Foot Exercises on Wound Healing in Type 2 Diabetic Patients With a Foot Ulcer: A Randomized Control Study. J Wound Ostomy Continence Nursing. 2018;45(2):123-130. (Abstract)

Authors' Response to a Letter to the Editor Re: The Effect of Foot Exercises on Wound Healing in Type 2 Diabetic Patients With a Foot Ulcer: A Randomized Control Study. J Wound Ostomy Continence Nursing. 2018;45(2):123-130. 30395122 2019 10 03 2019 10 07 1528-3976 45 6 2018 Nov/Dec Journal of wound, ostomy, and continence nursing : official publication of The Wound, Ostomy and Continence Nurses Society J Wound Ostomy Continence Nurs Authors' Response to a Letter to the Editor Re: The Effect (...) of Foot Exercises on Wound Healing in Type 2 Diabetic Patients With a Foot Ulcer: A Randomized Control Study. J Wound Ostomy Continence Nursing. 2018;45(2):123-130. 495 10.1097/WON.0000000000000485 Eraydın Şahizer Ş Health Sciences Faculty, Nursing Department, Gaziosmanpasa University, Tokat, Turkey. eng Letter Comment United States J Wound Ostomy Continence Nurs 9435679 1071-5754 N J Wound Ostomy Continence Nurs. 2018 Mar/Apr;45(2):123-130 29521922 J Wound Ostomy Continence Nurs. 2018 Nov/Dec;45(6

2019 Journal of wound, ostomy, and continence nursing : official publication of The Wound, Ostomy and Continence Nurses Society Controlled trial quality: uncertain

6. The Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification system predicts wound healing but not major amputation in patients with diabetic foot ulcers treated in a multidisciplinary setting Full Text available with Trip Pro

The Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification system predicts wound healing but not major amputation in patients with diabetic foot ulcers treated in a multidisciplinary setting The Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) threatened limb classification has been shown to correlate well with risk of major amputation and time to wound healing in heterogeneous diabetic and nondiabetic populations. Major amputation (...) continues to plague the most severe stage 4 WIfI patients, with 1-year amputation rates of 20% to 64%. Our aim was to determine the association between WIfI stage and wound healing and major amputation among patients with diabetic foot ulcers (DFUs) treated in a multidisciplinary setting.All patients presenting to our multidisciplinary DFU clinic from July 2012 to December 2015 were enrolled in a prospective database. Wound healing and major amputation were compared for patients stratified by WIfI

2017 EvidenceUpdates

7. Diabetic Foot Ulcers: Wound Management

Diabetic Foot Ulcers: Wound Management Diabetic Foot Ulcers: Wound Management | National Guideline Clearinghouse success fail JUL Aug 12 2017 2018 2019 02 Oct 2017 - 13 Jul 2018 COLLECTED BY Organization: Formed in 2009, the Archive Team (not to be confused with the archive.org Archive-It Team) is a rogue archivist collective dedicated to saving copies of rapidly dying or deleted websites for the sake of history and digital heritage. The group is 100% composed of volunteers and interested (...) * Remember Me Don't have an account? The AHRQ National Guideline Clearinghouse (NGC, guideline.gov) Web site will not be available after July 16, 2018 because federal funding through AHRQ will no longer be available to support the NGC as of that date. For additional information, read our . Guideline Synthesis Diabetic Foot Ulcers: Wound Management Guidelines Being Compared: International Working Group on the Diabetic Foot (IWGDF) IWGDF guidance on use of interventions to enhance the healing of chronic

2017 National Guideline Clearinghouse (partial archive)

8. Authors' Response to Letter to the Editor Re: The Effect of Foot Exercises on Wound Healing in Type 2 Diabetic Patients With a Foot Ulcer: A Randomized Control Study. (Abstract)

Authors' Response to Letter to the Editor Re: The Effect of Foot Exercises on Wound Healing in Type 2 Diabetic Patients With a Foot Ulcer: A Randomized Control Study. 29994857 2019 10 03 2019 10 07 1528-3976 45 4 2018 Jul/Aug Journal of wound, ostomy, and continence nursing : official publication of The Wound, Ostomy and Continence Nurses Society J Wound Ostomy Continence Nurs Authors' Response to Letter to the Editor Re: The Effect of Foot Exercises on Wound Healing in Type 2 Diabetic Patients (...) With a Foot Ulcer: A Randomized Control Study. 300 10.1097/WON.0000000000000454 Eraydın Şahizer Ş Health Sciences Faculty, Nursing Department, Gaziosmanpasa University, Tokat, Turkey. eng Letter Comment United States J Wound Ostomy Continence Nurs 9435679 1071-5754 N J Wound Ostomy Continence Nurs. 2018 Mar/Apr;45(2):123-130 29521922 J Wound Ostomy Continence Nurs. 2018 Jul/Aug;45(4):298 29994856 Diabetes Mellitus, Type 2 Diabetic Foot Foot Foot Ulcer Humans Wound Healing 2018 7 12 6 0 2018 7 12 6 0 2019

2019 Journal of wound, ostomy, and continence nursing : official publication of The Wound, Ostomy and Continence Nurses Society Controlled trial quality: uncertain

9. A Multinational, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy of Cyclical Topical Wound Oxygen Therapy (TWO2) in the Treatment of Chronic Diabetic Foot Ulcers: The TWO2 Study (Abstract)

A Multinational, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy of Cyclical Topical Wound Oxygen Therapy (TWO2) in the Treatment of Chronic Diabetic Foot Ulcers: The TWO2 Study Topical oxygen has been used for the treatment of chronic wounds for more than 50 years. Its effectiveness remains disputed due to the limited number of robust high-quality investigations. The aim of this study was to assess the efficacy of multimodality cyclical pressure (...) Topical Wound Oxygen (TWO2) home care therapy in healing refractory diabetic foot ulcers (DFUs) that had failed to heal with standard of care (SOC) alone.Patients with diabetes and chronic DFUs were randomized (double-blind) to either active TWO2 therapy or sham control therapy-both in addition to optimal SOC. The primary outcome was the percentage of ulcers in each group achieving 100% healing at 12 weeks. A group sequential design was used for the study with three predetermined analyses and hard

2019 EvidenceUpdates

10. Randomized clinical study to compare negative pressure wound therapy with simultaneous saline irrigation and traditional negative pressure wound therapy for complex foot infections. Full Text available with Trip Pro

Randomized clinical study to compare negative pressure wound therapy with simultaneous saline irrigation and traditional negative pressure wound therapy for complex foot infections. 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

2019 Wound Repair and Regeneration Controlled trial quality: predicted high

11. Semiclosure wound therapy plus negative pressure wound therapy for an older patient with grade 4 diabetic foot with concomitant vascular occlusion: A case report. Full Text available with Trip Pro

Semiclosure wound therapy plus negative pressure wound therapy for an older patient with grade 4 diabetic foot with concomitant vascular occlusion: A case report. Grade 4 diabetic foot (DF) is a severe infection that causes bone destruction, osteomyelitis, and osteoarticular damage, which, in turn, can lead to serious dry or wet gangrene, or amputation. DF is extremely difficult to treat.A 71-year-old female patient with long-term diabetes complicated with uremia, who undergoes regular (...) nutrition and microcirculation, controlling blood glucose, as well as balancing electrolytes were performed to ameliorate the general conditions. Nibbled debridement was used to remove devitalized tissues each time to maintain as much vital cells as possible. Open therapy was used for necrotic tissues, and dressings therapy was used simultaneously for the infected lesion. This combined treatment, involving open therapy with dressing, is referred to as "semiclosure wound therapy." Negative pressure wound

2019 Medicine

12. [The Study of Influence of Different Methods of Local Treatment on Wound Healing in Patients with Diabetic Foot Ulcers]. Full Text available with Trip Pro

[The Study of Influence of Different Methods of Local Treatment on Wound Healing in Patients with Diabetic Foot Ulcers]. To evaluate the influence of different methods of local treatment on tissue repair in patients with diabetic foot ulcers.We evaluated such clinical characteristics as wound size and local perfusion after using negative pressure wound therapy (NPWT), local collagen, and standard care in patients with diabetic foot ulcers. We observed 63 patients with neuropathic (...) and neuroischemic forms of diabetic foot (without critical ischemia) after surgical debridement. After that 21 patients received NPWT, 21 local collagen treatment and 21 ― standard care.After using NPWT wound area and depth decreased in 19,8% and 42,8% (p<0.05), in group of collagen dressings in 26,4 and 30,4% (p<0.05). In control group those parameters were 17,0 и 16.6% respectively (p<0.05). There was found the significant increase of local perfusion according to oxygen monitoring in group of NPWT (p<0.05

2018 Vestnik Rossiiskoi akademii meditsinskikh nauk Controlled trial quality: uncertain

13. The Effect of Foot Exercises on Wound Healing in Type 2 Diabetic Patients With a Foot Ulcer: A Randomized Control Study. (Abstract)

The Effect of Foot Exercises on Wound Healing in Type 2 Diabetic Patients With a Foot Ulcer: A Randomized Control Study. The purpose of this study was to investigate the effect of foot exercises on wound healing in type 2 diabetic patients with a diabetic foot ulcer.Prospective, randomized controlled study.Sixty-five patients from an outpatient clinic with grade 1 or 2 ulcers (Wagner classification) who met study criteria agreed to participate; 60 patients completed the study and were included (...) in the final analysis. Subjects were followed up between February 2014 and June 2015.Subjects were recruited by the researchers in the clinics where they received treatment. Subjects were randomly allocated to either the control or intervention group. Data were collected using investigator-developed forms: patient information form and the diabetic foot exercises log. Patients in the intervention group received standard wound care and performed daily foot exercises for 12 weeks; the control group received

2018 Journal of wound, ostomy, and continence nursing : official publication of The Wound, Ostomy and Continence Nurses Society Controlled trial quality: uncertain

14. Impact of Pedal Arch Patency on Tissue Loss and Time to Healing in Diabetic Patients with Foot Wounds Undergoing Infrainguinal Endovascular Revascularization Full Text available with Trip Pro

Impact of Pedal Arch Patency on Tissue Loss and Time to Healing in Diabetic Patients with Foot Wounds Undergoing Infrainguinal Endovascular Revascularization To retrospectively evaluate the impact of pedal arch quality on tissue loss and time to healing in diabetic patients with foot wounds undergoing infrainguinal endovascular revascularization.Between January 2014 and June 2015, 137 consecutive diabetic patients with foot wounds underwent infrainguinal endovascular revascularization (femoro (...) < 0.001). Estimated 1-year survival was significantly better in patients with CPA (CPA 90% vs. IPA 80.8% vs. APA 62.7%, p = 0.004).Pedal arch status has a positive impact on time to healing, limb salvage, and survival in diabetic patients with foot wounds undergoing infrainguinal endovascular revascularization.

2018 Korean Journal of Radiology

15. Vancouver Foot and Ankle WNS (Wound, Nerve, and Systemic) Classification System for Foot and Ankle Orthopedic Surgery. (Abstract)

Vancouver Foot and Ankle WNS (Wound, Nerve, and Systemic) Classification System for Foot and Ankle Orthopedic Surgery. Adverse events require consistent recording to determine the effect of alternate treatments. This study was undertaken to evaluate the Vancouver Foot and Ankle WNS complication scale to capture complications (W: wound, N: nerve, S: systemic) to assist in outcome recording.Interrater reliability was tested in 2 settings: (1) between 2 blinded clinicians in a live clinical (...) setting and (2) between 8 orthopedic surgeons using case vignettes based on a retrospective analysis of 500 foot and ankle procedures performed at the Toronto Western Hospital, Department of Orthopaedics. The intrarater reliability of the WNS scale was tested in a single rater using the case vignettes. Inter- and intrarater reliability were assessed using the Fleiss and Cohen weighted kappa ( k), respectively and 95% confidence intervals (CIs). There was adequate power over 0.8.In the live clinical

2018 Foot & Ankle International

16. CODIFI (Concordance in Diabetic Foot Ulcer Infection): a cross-sectional study of wound swab versus tissue sampling in infected diabetic foot ulcers in England. Full Text available with Trip Pro

CODIFI (Concordance in Diabetic Foot Ulcer Infection): a cross-sectional study of wound swab versus tissue sampling in infected diabetic foot ulcers in England. To determine the extent of agreement and patterns of disagreement between wound swab and tissue samples in patients with an infected diabetic foot ulcer (DFU).Multicentre, prospective, cross-sectional study.Primary and secondary care foot ulcer/diabetic outpatient clinics and hospital wards across England.Inclusion criteria: consenting (...) % male) from 25 centres.Most prevalent reported pathogens were Staphylococcus aureus (43.8%), Streptococcus (16.7%) and other aerobic Gram-positive cocci (70.6%). At least one potential pathogen was reported from 70.1% of wound swab and 86.1% of tissue samples. Pathogen results differed between sampling methods in 58% of patients, with more pathogens and fewer contaminants reported from tissue specimens.The majority of pathogens were reported significantly more frequently in tissue than wound swab

2018 BMJ open

17. Prognostic value of the Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification in patients with no-option chronic limb-threatening ischemia (Abstract)

Prognostic value of the Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification in patients with no-option chronic limb-threatening ischemia The Wound, Ischemia, and foot Infection (WIfI) classification was developed to assess amputation risk and hence to aid in clinical decision-making in patients with chronic limb-threatening ischemia (CLTI). WIfI has been validated in multiple CLTI cohorts worldwide. In this study, we examined the relationship between WIfI (...) marrow mononuclear cells in no-option CLTI patients (N = 160). We conducted a retrospective analysis incorporating baseline and follow-up data from the JUVENTAS trial. All wounds were photographed and described at the start and end of the trial to allow WIfI staging. Two independent researchers retrospectively classified all limbs according to the WIfI scheme, which was then related to prospectively collected trial data. Outcomes including wound healing, clinical improvement, minor and major

2018 EvidenceUpdates

18. Use of the Wound, Ischemia, foot Infection classification system in hemodialysis patients after endovascular treatment for critical limb ischemia (Abstract)

Use of the Wound, Ischemia, foot Infection classification system in hemodialysis patients after endovascular treatment for critical limb ischemia The Wound, Ischemia, foot Infection (WIfI) classification system is used to predict the amputation risk in patients with critical limb ischemia (CLI). The validity of the WIfI classification system for hemodialysis (HD) patients with CLI is still unknown. This single-center study evaluated the prognostic value of WIfI stages in HD patients with CLI (...) who had been treated with endovascular therapy (EVT).A retrospective analysis was performed of collected data on CLI patients treated with EVT between April 2007 and December 2015. All patients were classified according to their wound status, ischemia index, and extent of foot infection into the following four groups: very low risk, low risk, moderate risk, and high risk. Comorbidities and vascular lesions in each group were analyzed. The prognostic value of the WIfI classification was analyzed

2018 EvidenceUpdates

19. Clinical study for external washing by traditional Chinese medicine in the treatment of multiple infectious wounds of diabetic foot: Study protocol clinical trial (SPIRIT compliant). Full Text available with Trip Pro

Clinical study for external washing by traditional Chinese medicine in the treatment of multiple infectious wounds of diabetic foot: Study protocol clinical trial (SPIRIT compliant). Diabetic foot (DF) is among the most serious complications of type 2 diabetes. DF infection (DFI) is a key factor in the deterioration and development of DF, so controlling infection plays an important role in the treatment of the disease. Traditional Chinese medicine foot bath has been widely used in China (...) as a complementary and alternative therapy to improve circulation and infection control of DF. However, the existing evidence shows that its efficacy and safety are still insufficient. We report a study protocol about a multicenter, double-blind, randomized, placebo controlled trial which aims to make well-designed clinical trials to evaluate the efficacy and safety of herbal medicine foot bath decoction (FBD) and explore the mechanism of external washing of Chinese herbs in DFI.This study is a multicenter

2020 Medicine

20. Negative pressure wound therapy for wounds healing by secondary intention

was analysed, while in 2 studies (Kakagia 2014 [168] and VAC 2001-06 [202]), at least 1 wound per patient was analysed. The included studies comprised a wide range of different wounds of varying aetiologies, specifically: ? Amputation wounds (n = 1 study) (Liao 2012 [172]), ? Decubitus wounds (n = 2) (Ashby 2012 [128], VAC 2001-01 [197]), ? Diabetic foot wounds (n = 6) (Dalla Paola 2010 S-II [144], DiaFu [150], Karatepe 2011 [169], Nain 2011 [180], VAC 2001-07 [210], VAC 2001-08 [218]), ? Diabetic ulcer (...) wounds (n = 1) (Novinšcak 2010), ? Foot wounds (n = 1) (Chiang 2017 [141]), ? Fasciotomy wounds due to compartment syndrome (n = 1) (Kakagia 2014), ? Necrotising fasciitis wounds (n = 2) (Huang 2006 [160], Xu 2015 [235]), ? Open fractures (n = 7) (Arti 2016 [126], Gupta 2013 [158], Jayakumar 2013 [166], Sibin 2017 [188], VAC 2001-06, Virani 2016 [226], WOLLF [233]), Extract of final report N17-01A Version 1.1 Negative pressure wound therapy – wounds healing by secondary intention 25 June 2019

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

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