scholarly journals Efficacy and safety of the combination of isosorbide dinitrate spray and chitosan gel for the treatment of diabetic foot ulcers: A double-blind, randomized, clinical trial

2018 ◽  
Vol 15 (4) ◽  
pp. 348-351 ◽  
Author(s):  
Sylvia Elena Totsuka Sutto ◽  
Yunuen Itzet Rodríguez Roldan ◽  
Ernesto German Cardona Muñoz ◽  
Teresa Arcelia Garcia Cobian ◽  
Sara Pascoe Gonzalez ◽  
...  

Aim: To evaluate whether a combination of isosorbide dinitrate spray and chitosan gel (10%) topically applied can have additive benefits for management of diabetic foot ulcers. Methods: In a randomized, placebo-controlled, double-blinded clinical trial, 68 patients were divided into four groups: Group 1: treated with chitosan gel; Group 2: isosorbide dinitrate spray; Group 3: combination of isosorbide dinitrate spray and chitosan gel; Group 4: placebo. Results: Histological analyses showed a significant regeneration in all groups ( p < 0.001). On the final assessment of the ulcer, using the combination was found a wound closure percentage of 71 ± 30, 70 ± 27 using isosorbide dinitrate, 58 ± 30 with chitosan and 50 ± 16 with placebo. The number of patients who achieved complete ulcer closure was six using the combination, four with isosorbide dinitrate, three with chitosan and one with placebo. The progression in the healing process of the ulcer showed marked inmunohistochemical differences of Von Willebrand Factor, desmin, vascular endothelial growth factor-A and α-smooth muscle actin in all groups ( p < 0.001), but without notable differences between them. Conclusion: The combination was better than placebo to reduce the dimensions of the ulcer, accelerate healing and increase the number of patients who achieved complete closure of the ulcer, but the combination was not better than chitosan or isosorbide dinitrate used separately.

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.


2018 ◽  
Vol 2018 ◽  
pp. 1-5 ◽  
Author(s):  
Punyanuch Jindatanmanusan ◽  
Sivat Luanraksa ◽  
Tanit Boonsiri ◽  
Thirayost Nimmanon ◽  
Pasra Arnutti

Background and Objective. Evidence for the roles of matrix metalloproteinases-9 (MMP-9) in the healing process of diabetic foot ulcers has remained unclear. We therefore aimed to demonstrate the relationship of MMP-9 with the wound healing process and determine its potential usefulness in predicting the wound healing outcome. Methods. Twenty-two patients with diabetic foot ulcer were recruited. The wound size was determined, and the wound fluid was collected for the measurement of MMP-9 levels using an ELISA during the 12-week follow-up period regularly. The patients were categorized as good healers and poor healers when the wound area reduction was ≥ 50% and < 50% at week 4 when compared to the initial wound size at week 0. Results. Median wound fluid MMP-9 levels in the poor healer group were shown to be significantly higher than those in the good healer group (1.03 pg/µg protein vs. 0.06 pg/µg protein, p = 0.001), and the levels fluctuated throughout the 12-week follow-up period. In contrast to the poor healer group, the MMP-9 levels were demonstrated to be constantly low throughout the follow-up period in the good healer group. ROC analysis showed that the MMP-9 level of 0.38 pg/µg protein was able to predict the wound healing outcome with the sensitivity of 81.8%, the specificity of 64.6%, and the area under the curve of 0.901 (CI 0.78-1.03, p = 0.001). Conclusion. These findings suggested that determination of wound fluid MMP-9 levels might become a promising biomarker predicting wound healing outcomes and a novel potential therapeutic target for diabetic foot ulcers.


2019 ◽  
Vol 2 (2) ◽  
pp. 20-28
Author(s):  
Anita Sukarno ◽  
Nur Hidayah ◽  
Musdalifah Musdalifah

Background: Diabetic foot ulcers were common diabetes complication that progressively growth globally. The effectivity of Manuka honey in wound healing process was huge published currently. Modern dressing and Manuka honey may not affordable and cost effective since these dressings were not produced originally in Indonesia. In addition, the published study of Indonesian honey is still lack. Therefore, we conducted this study to investigate the effectivity of Indonesian honey in diabetic foot ulcers healing process. Method: This study design was observational case study. This study was conducted among type 2 diabetes with diabetic foot ulcers in Griya Afiat Homecare and ETN Center in Makassar City, Indonesia from March to June 2014. The Bates Wound Assessment Tool (BWAT) were used to collect the score of diabetic foot ulcer healing process regarding wound size, depth, edges, undermining, necrotic tissue type, necrotic amount, granulation, epithelization, exudate type and amount, surrounding skin color, edema and induration. Descriptive, Independent t-test, Analysis of Variance (ANOVA) and Wilcoxon signed rank test were conducted appropriately. Results: In total, 10 type 2 diabetes patients with diabetic foot ulcers were participated. The factors associated with wound healing process were diabetes treatment (t= 2.44, p= 0.041) and primary dressing (t= -2.76, p= 0.025). The effect of honey primary dressing was in reducing wound size (p= 0.043), improving necrotic tissue type (p= 0.041), reducing necrotic tissue amount (p= 0.042), increasing granulation (p= 0.038) and epithelization (p= 0.042). In the counterpart, the effect of modern dressing was in improving necrotic tissue type (p= 0.046) and increasing granulation (p= 0.042). Conclusion: Indonesian honey is beneficial on diabetic foot ulcers healing process. Recommendation: Therefore, findings suggest that honey should be considered as the alternative, cost effective and beneficial wound dressing on the diabetic foot ulcers.


2020 ◽  
Vol 28 ◽  
pp. 100178
Author(s):  
Seyedeh Esmat Hosseini ◽  
Behnam Molavi ◽  
Alireza Goodarzi ◽  
Ahad Alizadeh ◽  
Alireza Yousefzadeh ◽  
...  

2015 ◽  
Vol 39 (1) ◽  
pp. 29-39 ◽  
Author(s):  
Karen L Andrews ◽  
Matthew T Houdek ◽  
Lester J Kiemele

Background: Hospital-based studies have shown that mortality rates in individuals with diabetic foot ulcers are about twice those observed in individuals with diabetes without foot ulcers. Objective: To assess the etiology and management of chronic diabetic foot ulcers. Study design: Literature review. Methods: Systematic review of the literature discussing management of diabetic foot ulcers. Since there were only a few randomized controlled trials on this topic, articles were selected to attempt to be comprehensive rather than a formal assessment of study quality. Results: Chronic nonhealing foot ulcers occur in approximately 15% of patients with diabetes. Many factors contribute to impaired diabetic wound healing. Risk factors include peripheral neuropathy, peripheral arterial disease, limited joint mobility, foot deformities, abnormal foot pressures, minor trauma, a history of ulceration or amputation, and impaired visual acuity. With the current treatment for nonhealing diabetic foot ulcers, a significant number of patients require amputation. Conclusion: Diabetic foot ulcers are optimally managed by a multidisciplinary integrated team. Offloading and preventative management are important. Dressings play an adjunctive role. There is a critical need to develop novel treatments to improve healing of diabetic foot ulcers. The goal is to have wounds heal and remain healed. Clinical relevance Diabetic neuropathy and peripheral arterial disease are major factors involved in a diabetic foot ulcer. Despite current treatment modalities for nonhealing diabetic foot ulcers, there are a significant number of patients who require amputations. No known therapy will be effective without concomitant management of ischemia, infection, and adequate offloading.


2014 ◽  
Vol 83 (2) ◽  
pp. 172-174 ◽  
Author(s):  
Peyman Mikaili ◽  
Milad Moloudizargari ◽  
Shahin Aghajanshakeri

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