scholarly journals Effect of a topical gel based on Adelmidrol + Trans-traumatic acid in the treatment of diabetic foot ulcers: an open-label study

Author(s):  
Ilaria Teobaldi ◽  
Vincenzo Stoico ◽  
Fabrizia Perrone ◽  
Alessandro Mantovani ◽  
Patrizia Piccagli ◽  
...  

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.

Author(s):  
Sahar Moeini ◽  
Hans Gottlieb ◽  
Tue S. Jørgensen ◽  
Malene R. B. Larsen ◽  
Stig Brorson

Chronic foot ulcers have extensive consequences for diabetic patients’ quality of life and increase risks of amputation and death. The aim of this trial was to assess the feasibility of conducting a larger clinical trial to evaluate the clinical effect of inforatio technique on healing of diabetic foot ulcers (DFUs). Inforatio technique is a novel minimal invasive procedure where small cuts are made on wound beds with punch biopsy tools. This study was a feasibility trial conducted at an outpatient wound care clinic at Zealand University Hospital. Twelve patients with DFUs were included. During a 90-day follow-up, participants visited the clinic 5 times and received inforatio technique twice. Feasibility was assessed with regard to recruitment, acceptability, burden, benefits, protocol adherence, and adverse events. The recruitment rate was 1 patient per eighth day (95% confidence interval [CI] = [4th-13th]), and the retention rate was 100% (95% CI = [74-100]). During follow-up, healing was observed for 4 ulcers (33%, 95% CI = [10-65]) with a mean time for healing of 59 days (range, 22-89) (95% CI = [5-113]). Five ulcers had a reduction of wound area and 3 ulcers had an increase in area from baseline to 90-day follow-up. No temporal relationship was found between inforatio application and wound area increase. There were no patient-reported harmful effects and no adverse events with probable relation to inforatio technique. Patient acceptability and participant adherence were promising. Thus, a larger clinical trial for evaluating the clinical effect of inforatio technique is considered feasible to conduct.


2021 ◽  
Vol 8 (34) ◽  
pp. 3200-3204
Author(s):  
Bathena Sobha Rani ◽  
Gandikota Venkata Prakash ◽  
Budamala Sarada ◽  
Bharath Kumar Desu ◽  
Yadhuf Krishnan

BACKGROUND Diabetic patients have reduced ability to metabolize glucose resulting in elevated blood sugar levels which further burdens the wound healing process. This leads to non-healing chronic ulcers. The sufferers of chronic diabetic foot ulcers are increasing globally due to lack of preventive and control measures. Sucralfate has been demonstrated in molecular studies to enhance the granulation tissue proliferation and thus promoting ulcer healing in the skin. Various clinical studies have also showed the efficacy of sucralfate in complete healing of the wound and in reducing the size of the wound. The purpose of this study was to compare the efficacy of topical sucralfate with that of povidone iodine dressing, in the healing of diabetic ulcers. METHODS This is a randomized comparative study. Among 100 patients, 50 patients received treatment in the form of povidone iodine dressings and 50 took treatment with sucralfate dressing. The patient underwent a detailed clinical examination. Relevant investigations were also done. The initial wound area was recorded after thorough debridement by measuring length x width. Both the groups underwent dressings once daily. The patients were followed up daily for a period of 3 weeks in both the groups. RESULTS In this study, the mean ± SD area of reduction of the ulcer was observed to be higher in sucralfate group 54.17 ± 10.08 than the povidone iodine group 16.07 ± 4.19. There was a statistically significant difference between the groups for the mean of area reduction (P < 0.0001, significant). CONCLUSIONS The ulcers in subjects treated with sucralfate dressing (S group) contracted more than the ulcers in the patients treated with povidone iodine (P group) (54.17 % Vs 16.07 %; P = < 0.0001, significant) which points out that sucralfate dressing is an effective modality in helping the reduction of wound area in patients with diabetic foot ulcers. KEYWORDS Diabetic, Sucralfate, Area of Reduction


2021 ◽  
Vol 30 (Sup5) ◽  
pp. S7-S14
Author(s):  
Thomas E Serena ◽  
Neal M Bullock ◽  
Windy Cole ◽  
John Lantis ◽  
Lam Li ◽  
...  

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.


2013 ◽  
Vol 20 (4) ◽  
pp. 389-393 ◽  
Author(s):  
Teodora Chiţă ◽  
Delia Muntean ◽  
Luminiţa Badiţoiu ◽  
Bogdan Timar ◽  
Roxana Moldovan ◽  
...  

Abstract Background and aims: Infected foot ulcer is one of the most feared complications of diabetes mellitus. Staphylococcus aureus is the most frequently isolated pathogen in diabetic foot infections. The aim of this study was to evaluate the prevalence of S. aureus strains involved in producing foot infections in diabetic patients and the antibiotic resistance pattern of these strains. Material and methods: The study included 33 S. aureus strains isolated from 55 diabetic foot ulcers. The subjects were selected from the 2465 patients with diabetes mellitus hospitalized in the Timişoara Diabetes Clinic, between 2011 and 2013. Germs’ identification relied on cultural and biochemical characteristics. Final identification and antimicrobial testing were performed using the Vitek 2 (Bio Merieux France) automatic analyzer. Results: All the 55 samples collected from diabetic foot ulcers were positive. We isolated 64 bacterial strains (some samples were positive for 2 microorganisms). The most frequently isolated germ was S. aureus, in 33 samples (51.56%). All these S. aureus strains showed resistance to benzylpenicillin, while only 33.33% were methicillin-resistant (MRSA). Conclusions: The most frequently isolated germ in the wound secretions from diabetic foot ulcers was S. aureus. The highest percentage of antimicrobial resistance was recorded to benzylpenicillin and erythromycin.


QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Amr Abdelaal ◽  
Mostafa Soliman ◽  
Hany Rafik ◽  
Mohamed Emam ◽  
Mohamed Mahmoud Mohamed Elsadek

Abstract Background Diabetic foot ulcers (DFUs) are the main cause of hospitalization in diabetic patients and they are considered a major worldwide health problem. Thus, there is a need to evaluate various treatment modalities. In this study we will assess the clinical efficacy of Silver nanoparticles dressing vs Standard Moist Wound Dressing (SMWD) in management of diabetic foot ulcers. Objective To compare wound outcome, limb salvage, healing time of diabetes related foot ulcers and cost effectiveness in terms of duration of hospital stay between Silver nanotechnology dressings and Standard moist wound therapy (SMWT) in management of diabetic foot ulcers. Patients and Methods This is a prospective randomized controlled study involving 34 patients with active diabetic foot ulcers, in a high volume tertiary referral vascular center. They were divided into 2 groups: 17 patients (group A) were prescribed SMWD and the other 17 patients (group B) received Silver nanoparticles wound dressing. Results Our study correlates with the study conducted by K.Suhas et al. which had observed that Silver nanoparticles wound dressing was safe and effective treatment for complex diabetic foot wounds and could lead to higher proportion of healed wounds and faster healing rates. At the end of the study, group B promised a better outcome as compared to group A. Conclusion The role of Silver nanoparticles wound dressing in healing of diabetic foot ulcers has been proposed as a novel method of manipulating the chronic wound environment in a way that it reduces bacterial burden and chronic interstitial wound fluid, increases vascularity and cytokine expression and to an extent mechanically exploiting the viscoelasticity of peri wound tissues.


2020 ◽  
Author(s):  
Olufunmilayo O Adeleye ◽  
Ejiofor T Ugwu ◽  
Ibrahim D Gezawa ◽  
Innocent Okpe ◽  
Ignatius Ezeani ◽  
...  

Abstract Background: Diabetic foot ulcers (DFU) are associated with high morbidity and mortality globally. Mortality in patients hospitalized for DFU in Nigeria is unacceptably high. This study was undertaken to determine factors that predict mortality in patients hospitalized for DFU in Nigeria.Methods:The current study was part of Multi-centre Evaluation of Diabetic Foot Ulcer in Nigeria (MEDFUN), an observational study conducted in six tertiary healthcare institutions across the 6 geopolitical zones of Nigeria. Consecutive type 1 or 2 diabetic patients hospitalized for DFU who consented to participate were recruited and subjected to relevant clinical, biochemical and radiological assessments and multidisciplinary care until discharge or death. Data for type 1 diabetes mellitus (DM) patients were expunged from current mortality analysis due to their small number.Results: Three hundred and twenty three type 2 DM subjects with mean age and mean duration of DM of 57.2 11.4 years and 8.7± 5.8 years respectively participated in this study. The median duration of ulcers was 39 days with a range of 28 to 54 days and majority (79.9%) presented with advanced ulcers of at least Wagner grade 3. Mortality of 21.4% was recorded in the study, with the highest mortality observed among subjects with Wagner grade 5. Variables significantly associated with mortality with their respective p values were DM duration more than 120 months (p 0.005), ulcer duration > one month (p 0.020), ulcer severity of Wagner grade 3 and above (p 0.001), peripheral arterial disease (p 0.005), proteinuria (p <0.001), positive blood cultures (p<0.001), low HDL (p <0.001), shock at presentation (p<0.001), cardiac failure (p 0.027),and renal impairment (p <0.001). On Multivariate regression analysis, presence of bacteraemia (OR 5.053; 95% CI 2.572-9.428) and renal impairment (OR 2.838; 95% CI 1.349 – 5.971) were significantly predictive of mortality independent of other variables.Conclusions: This study showed high intra-hospital mortality among patients with DFU, with majority of deaths occurring among those with advanced ulcers, bacteremia, cardiac failure and renal impairment. Prompt attention to these factors might be helpful in improving survival from DFU in Nigeria.


2021 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Chinedum Ogbonnaya Eleazu ◽  
Aniza Abd Aziz ◽  
Tay Chuu Suen ◽  
Lam Chun-Hau ◽  
Chin Elynn ◽  
...  

Purpose This study aims to design to assess the traditional, complementary and alternate medicine (TCAM) usage and its association with the quality of life (QOL) of Type 2 diabetic patients in a tertiary hospital (Hospital Universiti Sains Malaysia) in Malaysia. Design/methodology/approach A total of 300 respondents included in this study were divided into the following two major categories: TCAM (34.33% of respondents) and non-TCAM users (65.67% of the respondents), respectively. The mean ages of the respondents were 59.3 ± 10.2 for the TCAM users and 57.7 ± 12.0 for the non-TCAM users. Findings A greater percentage of non-TCAM users reported poor control of diabetes (14.7%) and blood glucose (55.8%) compared with the TCAM users (9.7% and 48.5%, respectively). Further, the diabetic patients on TCAM reported lower rates of coma, stroke and kidney problems but higher rates of diabetic foot ulcers, heart diseases and retinopathy than the non-TCAM users. Additionally, the diabetic patients with TCAM usage had a significantly better physical (p = 0.02) and overall (p = 0.03) qualities of life compared to the non-TCAM users. However, psychological, social and environmental health did not show any significant difference. Originality/value The prevalence of TCAM usage among diabetic patients was lower than in other comparable studies. Diabetic patients on TCAM reported lower rates of coma, stroke and kidney problems but higher rates of diabetic foot ulcers, heart diseases and retinopathy than the non-TCAM users. Further, diabetes patients on TCAM reported better QOL compared to non-TCAM users especially in terms of physical health.


2016 ◽  
Vol 04 (01) ◽  
pp. 017-024 ◽  
Author(s):  
Andrew Steel ◽  
John Reece ◽  
Anne-Marie Daw

AbstractThe prevalence of diabetes is increasing, as is the cost of managing its comorbidities. Diabetic foot ulcers (DFUs) and their complications place a considerable cost burden on the health system, and lead to a significant level of disability. The relationship between depression and diabetes is well-established. The relationship between depression and foot ulcers in diabetic patients is less well-established. The purpose of this article is to provide a current concept review of the literature from 1988 to 2013, linking DFUs and depressive symptoms, with an emphasis on the impact depressive symptoms have on healing rates of DFUs. Articles specifically focusing on the biological relationship, depression′s impact on self-care, screening for depressive symptoms, causes and cost of treating DFUs, and measuring depression were reviewed. A deeper understanding of this relationship is needed to identify causal relationships, improve treatment outcomes, and reduce healing times of DFUs.


2020 ◽  
Vol 29 (9) ◽  
pp. 518-524
Author(s):  
Ismail Toygar ◽  
Ilgin Yildirim Simsir ◽  
Sevki Cetinkalp

Objective: Wound surface area can be measured with several assessment tools, including a manual planimetric method, ImageJ software and three-dimensional wound measurement (3DWM) methods. This study aimed to determine the advantages of each method as well as the concordance between them. Method: This reproducibility study included adult patient volunteers with diabetic foot ulcers (DFUs). Wounds with ambiguous borders were excluded. All included wounds were sequentially assessed with each of the three measurement methods, and the time for each measurement was recorded with a chronometer. SPSS and MedCalc package software were used for all statistical analyses. Results: A total of 20 patients with 20 DFUs took part in the study. According to the measurement method, the average wound area was 6.41cm2 by the manual planimetric method, 6.53cm2 by ImageJ and 6.32cm2 by 3DWM. Correlation analyses revealed correlation coefficients of 0.997 between the manual planimetric method and ImageJ, 0.929 between the manual planimetric method and 3DWM, and 0.929 between ImageJ and 3DWM. Bland–Altman analysis was used to determine whether these three measurement methods could be used interchangeably. There was no significant difference between the three measurement methods and, therefore, it was concluded that they could be used interchangeably. Wound area measurement times were 173.35±19.38 seconds by the manual planimetric method, 61.60±9.21 seconds by ImageJ and 36.90±6.91 seconds by the 3DWM method. Conclusion: The three measurement methods studied can be used interchangeably, as each method is highly concordant with the other two. The fastest method was 3DWM and the manual planimetric method was the slowest.


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