scholarly journals An Observational Clinical Trial Examining the Effect of Topical Oxygen Therapy (Natrox™) on the Rates of Healing of Chronic DiAbetic Foot Ulcers (OTONAL Trial)

2021 ◽  
pp. 153473462110536
Author(s):  
Tjun Yip Tang ◽  
Manfred Y. Q. Mak ◽  
C. J. Q. Yap ◽  
J. E. C. Boey ◽  
Sze Ling Chan ◽  
...  
Keyword(s):  
Diabetic Foot ◽  
Distribution System ◽  
Oxygen Therapy ◽  
Atmospheric Oxygen ◽  
Foot Ulcer ◽  
Glycated Haemoglobin ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Transcutaneous Oxygen ◽  
The Mean

Natrox™ topical oxygen therapy (TOT) ( Inotec AMD Ltd, Hertfordshire, UK) employs a small battery-powered “oxygen generator” to concentrate atmospheric oxygen and feeds pure, moist, oxygen through a fine, soft tube to a dressing-like “oxygen distribution system”, which is placed over the wound and is held in place by a conventional dressing. The aim was to determine the effectiveness of Natrox™ for non-healing diabetic foot ulcers (DFU) over a 3-month period.Longitudinal, single-arm, open prospective registry study using 12 weeks of TOT using a 4 week run-in period. 20 patients recruited to OTONAL had chronic DFU greater than 3 months duration or minor amputation sites with less than 50% healing in 4 weeks.There were 13 (65%) males and the mean age was 65.7 (±11.6) years. The mean glycated haemoglobin (HbA1c) was 6.9 (±1.3) mmol mol−1 and mean wound duration before TOT was 114 (±79.1) days. 18/20 (90.0%) patients had concomitant lower limb revascularization angioplasty for chronic limb threatening ischaemia. The mean size of the foot ulcer at baseline was 11.3 ± 14.8 cm2 and mean transcutaneous oxygen measurement value was 34.1 (±19.6) mm Hg. Wound closure of >75% was observed in 14/20 (70.0%) patients. There was a 91.3% (±14.9%) wound area reduction by 3 months (P = .001) and mean time for 100% closure was 77.6 ± 32.5 days. Mean pain scores reduced from 2.4 (±1.8) at baseline to .5 (±1.0) at 3 months (P = .008). All patients were very satisfied using the ambulatory device. Use of TOT in chronic diabetic foot wounds stimulates a healing state, underpinning the concept that oxygen plays a central role in wound healing. Our results are more compelling if you consider they started with relatively large-sized DFUs and majority of patients were frail with underlying peripheral artery disease. (NCT03863054)

scholarly journals IGF-1 Increases with Hyperbaric Oxygen Therapy and Promotes Wound Healing in Diabetic Foot Ulcers

2013 ◽  
Vol 2013 ◽  
pp. 1-6 ◽  
Author(s):  
Figen Aydin ◽  
Ahmet Kaya ◽  
Levent Karapinar ◽  
Mert Kumbaraci ◽  
Ahmet Imerci ◽  
...  
Keyword(s):  
Wound Healing ◽  
Hyperbaric Oxygen ◽  
Diabetic Foot ◽  
Hyperbaric Oxygen Therapy ◽  
Oxygen Therapy ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Significant Difference ◽  
The Mean ◽  
Design And Methods

Objectives. To investigate insulin-like growth factor I (IGF-1) levels in response to hyperbaric oxygen therapy (HBOT) for diabetic foot ulcers and to determine whether IGF-1 is a predictive indicator of wound healing in patients with diabetic foot ulcers.Design and Methods. We treated 48 consecutive patients with diabetic foot ulcers with HBOT. Alterations of IGF-1 levels in patients whose wound healed with HBOT were compared with those in patients who did not benefit from HBOT.Results. There was no significant difference in initial IGF-1 levels between the two groups(P=0.399). The mean IGF-1 level increased with HBOT(P<0.05). In the healed group, the mean IGF-1 increase and the final values were significantly higher(P<0.05). In the nonhealed group, the mean IGF-1 increase was minus and the final values were not significantly different(P<0.05). The increase in IGF-1 level with HBOT was significantly higher in the healed group(P<0.001).Conclusions. IGF-1 increased significantly in the healed group. We believe that HBOT is effective in the treatment of diabetic foot ulcers, with an elevation of IGF-1. This alteration seems to be a predictive factor for wound healing in diabetic foot ulcers treated with HBOT.

scholarly journals Comparison of Efficacy of Alginate Filler Dressings with Conventional Saline Dressings for Cavity Wounds in Diabetic Foot Ulcer- A Prospective Cohort Study

2020 ◽  
Author(s):  
Tharun Ganapathy Chitrambalam ◽  
Pradeep Joshua Christopher ◽  
Jeyakumar Sundaraj ◽  
Ramyasree Paladugu ◽  
Sundeep Selvamuthukumaran
Keyword(s):  
Cohort Study ◽  
Surface Area ◽  
Diabetic Foot ◽  
Foot Ulcer ◽  
Diabetic Foot Ulcer ◽  
Saline Group ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
The Mean ◽  
Culture Positive

Introduction: Diabetic foot ulcers are associated with 25% of patients with Diabetes Mellitus (DM). These diabetic foot ulcers if not given appropriate care at the right time can lead to amputations and poor quality of life. Alginate dressings are newer and help in faster healing of cavity wounds in diabetic foot ulcer. Aim: To compare the advantages of alginate dressings over conventional saline dressings in cavity wounds of diabetic foot ulcer patients. Materials and Methods: A single centre prospective longitudinal cohort study was conducted on 88 patients with diabetic foot ulcers randomising equally into two groups containing 44 patients in each group in a tertiary care hospital. The wounds of all patients included in the study were thoroughly debrided and initial assessment was done using the Pressure Ulcer Scale for Healing (PUSH) scoring system. The patients were started on alginate dressings in one group and saline dressings in other group and were assessed after two and four weeks. The reduction in the surface area of the wound, reduction in the exudate amount, type of the tissue over the ulcer and reduction in the bacterial load (wound cultures) of the ulcers were studied. The statistical analysis were done using Statistical Package for the Social Sciences (SPSS) software version 21. The statistics were done using independent sample tests (Levene’s test for equality of variances and t-test for equality of means), Mann-Whitney test and Wilcoxon test. Results: The results of wound assessment before dressings, at two weeks and at the end of four weeks are as follows: The mean (SD) reduction in wound surface area was 9.07 (1.634) to 6.89 (1.434) to 4.68 (1.272) for alginate group and 9.25 (2.059) to 8.00 (1.905) to 6.50 (1.650) for saline group. The mean (SD) reduction of the exudate amount was 2.02 (0.505) to 1.09 (0.473) to 0.14 (0.347) for alginate group and 1.98 (0.590) to 1.43 (0.625) to 0.75 (0.615) for the saline group. The mean (SD) for tissue type of cavity wounds assessed via PUSH scoring was reduced from 2.30 (0.701) to 0.16 (0.370) for the alginate group in comparison to 2.32 (0.740) to 0.77 (0.743) for the saline group at the end of four weeks. On evaluation of the wound cultures; 6 out of 44 patients (13.6%) were culture positive in the alginate group while 30 out of 44 patients (68.2%) were culture positive from the saline group at the end of four weeks. All the above results were statistically significant with a p-value of 0.001. Conclusion: Alginates dressings are superior to saline dressings in terms of reduction in the size of the ulcer and control of microbial activity in diabetic foot. Alginate absorbs large amount of exudates and fill in irregular shaped cavities which are ideal in treating cavity wounds in diabetic foot syndrome.

scholarly journals A case report: Treatment of chronic diabetic foot ulcer with Hyperbaric Oxygen Therapy

2021 ◽  
Vol 28 ◽  
pp. 221049172110127
Author(s):  
CW Chau Jeffrey ◽  
KS Leung Joe
Keyword(s):  
Diabetes Mellitus ◽  
Hyperbaric Oxygen ◽  
Diabetic Foot ◽  
Hyperbaric Oxygen Therapy ◽  
Management Strategy ◽  
Oxygen Therapy ◽  
Foot Ulcer ◽  
Diabetic Foot Ulcer ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers

Diabetes mellitus effects around 10% of the whole population and unhealed diabetic foot ulcer is one of the most debilitating and economically burdensome conditions. This condition is commonly seen by different specialists including physicians, orthopaedic surgeons and vascular surgeons. We present a case of unhealed diabetic foot ulcer which has been treated in our Hyperbaric Oxygen Therapy (HBOT) centre. We also review the literature with respect to management strategy and rationale of hyperbaric oxygen therapy for diabetic foot ulcers.

scholarly journals Emerging Diabetic Foot Ulcer Microbiome Analysis using Cutting Edge Technologies

2021 ◽  
pp. 193229682199009
Author(s):  
Brian M. Schmidt
Keyword(s):  
Diabetic Foot ◽  
Foot Ulcer ◽  
Diabetic Foot Ulcer ◽  
Standard Of Care ◽  
Molecular Techniques ◽  
Foot Ulcers ◽  
Care Practice ◽  
Antibiotic Administration ◽  
Diabetic Foot Ulcers ◽  
Conventional Culture

One of the most prevalent complications of diabetes mellitus are diabetic foot ulcers (DFU). Diabetic foot ulcers represent a complex condition placing individuals at-risk for major lower extremity amputations and are an independent predictor of patient mortality. DFU heal poorly when standard of care therapy is applied. In fact, wound healing occurs only approximately 30% within 12 weeks and only 45% regardless of time when standard of care is utilized. Similarly, diabetic foot infections occur in half of all DFU and conventional microbiologic cultures can take several days to process before a result is known. DFU represent a significant challenge in this regard because DFU often demonstrate polymicrobial growth, become resistant to preferred antibiotic therapy, and do not inform providers about long-term prognosis. In addition, conventional culture yields may be affected by the timing of antibiotic administration and collection of tissue for analysis. This may lead to suboptimal antibiotic administration or debilitating amputations. The microbiome of DFU is a new frontier to better understand the interactions between host organisms and pathogenic ones. Newer molecular techniques are readily available to assist in analyzing the constituency of the microbiome of DFU. These emerging techniques have already been used to study the microbiome of DFU and have clinical implications that may alter standard of care practice in the near future. Here emerging molecular techniques that can provide clinicians with rapid DFU-related-information and help prognosticate outcomes in this vulnerable patient population are presented.

scholarly journals Clinical profiles of diabetic foot ulcer patients undergoing major limb amputation at a tertiary care center in North-eastern Tanzania

BMC Surgery ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Ahmed Shabhay ◽  
Pius Horumpende ◽  
Zarina Shabhay ◽  
Andrew Mganga ◽  
Jeff Van Baal ◽  
...  
Keyword(s):  
Blood Glucose ◽  
Diabetic Foot ◽  
Care Center ◽  
Tertiary Care ◽  
Limb Amputation ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Random Blood Glucose ◽  
North Eastern ◽  
The Mean

Abstract Background Diabetic foot ulcers complications are the major cause of non-traumatic major limb amputation. We aimed at assessing the clinical profiles of diabetic foot ulcer patients undergoing major limb amputation in the Surgical Department at Kilimanjaro Christian Medical Centre (KCMC), a tertiary care hospital in North-eastern Tanzania. Methods A cross—sectional hospital-based study was conducted from September 2018 through March 2019. Demographic data were obtained from structured questionnaires. Diabetic foot ulcers were graded according to the Meggitt-Wagner classification system. Hemoglobin and random blood glucose levels data were retrieved from patients’ files. Results A total of 60 patients were recruited in the study. More than half (31/60; 51.67%) were amputated. Thirty-five (58.33%) were males. Fifty-nine (98.33%) had type II diabetes. Nearly two-thirds (34/60; 56.67%) had duration of diabetes for more than 5 years. The mean age was 60.06 ± 11.33 years (range 30–87). The mean haemoglobin level was 10.20 ± 2.73 g/dl and 9.84 ± 2.69 g/dl among amputees. Nearly two thirds (42/60; 70.00%) had a haemoglobin level below 12 g/dl, with more than a half (23/42; 54.76%) undergoing major limb amputation. Two thirds (23/31; 74.19%) of all patients who underwent major limb amputation had mean hemoglobin level below 12 g/dl. The mean Random Blood Glucose (MRBG) was 13.18 ± 6.17 mmol/L and 14.16 ± 6.10 mmol/L for amputees. Almost two thirds of the study population i.e., 42/60(70.00%) had poor glycemic control with random blood glucose level above 10.0 mmol/L. More than half 23/42 (54.76%) of the patients with poor glycemic control underwent some form of major limb amputation; which is nearly two thirds (23/31; 74.19%) of the total amputees. Twenty-eight (46.67%) had Meggitt-Wagner classification grade 3, of which nearly two thirds (17:60.71%) underwent major limb amputation. Conclusion In this study, the cohort of patients suffering from diabetic foot ulcers treated in a tertiary care center in north-eastern Tanzania, the likelihood of amputation significantly correlated with the initial grade of the Meggit-Wagner ulcer classification. High blood glucose levels and anaemia seem to be also important risk factors but correlation did not reveal statistical significance.

The Influence of Arterial Calcification on Clinical Outcomes in Patients with Diabetic Foot Ulcer Complicated by Osteomyelitis Treated by Surgery

2021 ◽  
pp. 153473462110225
Author(s):  
Marta Carmena-Pantoja ◽  
Francisco Javier Álvaro-Afonso ◽  
Esther García-Morales ◽  
Yolanda García-Álvarez ◽  
Aroa Tardáguila-García ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Diabetic Foot ◽  
Foot Ulcer ◽  
Diabetic Foot Ulcer ◽  
Arterial Calcification ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Time To Recurrence ◽  
Artery Disease ◽  
Clinical Records

The aim of our study was to analyze the influence of radiographic arterial calcification (RAC) on clinical outcomes and wound healing in patients with diabetic foot ulcers complicated by osteomyelitis treated by surgery. We analyzed retrospectively the clinical records of 102 patients with diabetic foot osteomyelitis who underwent surgery at a specialized diabetic foot unit between January 2014 and December 2016. The clinical data of evolution until its complete epithelialization and a follow-up 1 year were reviewed, and after reviewing the radiological images, patients were classified into 2 groups: those with RAC and those without RAC. We analyzed several clinical features in both groups. The presence of RAC was associated with a greater time of healing (10.68 ± 7.24 vs 8.11 ± 4.50 weeks; P = .029) and shorter time to recurrence and reulceration (13.30 ± 9.25 vs 18.81 ± 11.63 weeks; P = .036). However, this association was not found for patients with mild and moderate peripheral artery disease (PAD), whose time of healing was 8.97 ± 4.51 weeks compared to 9.16 ± 6.39 weeks for patients without PAD; P = .864. The time of healing of diabetic foot ulcers complicated by osteomyelitis treated by surgery can be negatively affected by the presence of RAC even more than by the presence of mild and moderate ischemia. The presence of RAC may offer clinical guidance at the level of primary care though this would need thorough validation in future studies.

scholarly journals Methicillin-Resistant Staphylococcus aureus (MRSA) Infection of Diabetic Foot Ulcers at a Tertiary Care Hospital in Accra, Ghana

Pathogens ◽  
2021 ◽  
Vol 10 (8) ◽  
pp. 937
Author(s):  
Ramzy B. Anafo ◽  
Yacoba Atiase ◽  
Nicholas T. K. D. Dayie ◽  
Fleischer C. N. Kotey ◽  
Patience B. Tetteh-Quarcoo ◽  
...  
Keyword(s):  
Staphylococcus Aureus ◽  
Multidrug Resistance ◽  
Teaching Hospital ◽  
Diabetic Foot ◽  
Foot Ulcer ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Coagulase Negative Staphylococci ◽  
Methicillin Resistant ◽  
Mrsa Infection

Aim: This study investigated the spectrum of bacteria infecting the ulcers of individuals with diabetes at the Korle Bu Teaching Hospital in Accra, Ghana, focusing on Staphylococcus aureus (S. aureus) and methicillin-resistant S. aureus (MRSA), with respect to their prevalence, factors predisposing to their infection of the ulcers, and antimicrobial resistance patterns. Methodology: This cross-sectional study was conducted at The Ulcer Clinic, Department of Surgery, Korle Bu Teaching Hospital, involving 100 diabetic foot ulcer patients. The ulcer of each study participant was swabbed and cultured bacteriologically, following standard procedures. Antimicrobial susceptibility testing was done for all S. aureus isolated, using the Kirby-Bauer method. Results: In total, 96% of the participants had their ulcers infected—32.3% (n = 31) of these had their ulcers infected with one bacterium, 47.9% (n = 46) with two bacteria, 18.8% (n = 18) with three bacteria, and 1.0% (n = 1) with four bacteria. The prevalence of S. aureus and MRSA were 19% and 6%, respectively. The distribution of the other bacteria was as follows: coagulase-negative Staphylococci (CoNS) (54%), Escherichia coli (24%), Pseudomonas spp. (19%), Citrobacter koseri and Morganella morgana (12% each), Klebsiella oxytoca (11%), Proteus vulgaris (8%), Enterococcus spp. (6%), Klebsiella pneumoniae (5%), Proteus mirabilis and Enterobacter spp. (4%), Klebsiella spp. (2%), and Streptococcus spp. (1%). The resistance rates of S. aureus decreased across penicillin (100%, n = 19), tetracycline (47.4%, n = 9), cotrimoxazole (42.1%, n = 8), cefoxitin (31.6%, n = 6), erythromycin and clindamycin (26.3% each, n = 5), norfloxacin and gentamicin (15.8% each, n = 3), rifampicin (10.5%, n = 2), linezolid (5.3%, n = 1), and fusidic acid (0.0%, n = 0). The proportion of multidrug resistance was 47.4% (n = 9). Except for foot ulcer infection with coagulase-negative Staphylococci, which was protective of S. aureus infection of the ulcers (OR = 0.029, p = 0.001, 95% CI = 0.004–0.231), no predictor of S. aureus, MRSA, or polymicrobial ulcer infection was identified. Conclusions: The prevalence of S. aureus and MRSA infection of the diabetic foot ulcers were high, but lower than those of the predominant infector, coagulase-negative Staphylococci and the next highest infecting agent, E. coli. Diabetic foot ulcers’ infection with coagulase-negative Staphylococci protected against their infection with S. aureus. The prevalence of multidrug resistance was high, highlighting the need to further intensify antimicrobial stewardship programmes.

Topical oxygen therapy in the treatment of diabetic foot ulcers: a multicentre, open, randomised controlled clinical trial

2021 ◽  
Vol 30 (Sup5) ◽  
pp. S7-S14
Author(s):  
Thomas E Serena ◽  
Neal M Bullock ◽  
Windy Cole ◽  
John Lantis ◽  
Lam Li ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Diabetic Foot ◽  
Oxygen Therapy ◽  
Wound Closure ◽  
Foot Ulcers ◽  
Controlled Clinical Trial ◽  
Diabetic Foot Ulcers ◽  
Open Label ◽  
Number Of Patients

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.

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