scholarly journals Topical Administration of Pirfenidone Increases Healing of Chronic Diabetic Foot Ulcers: A Randomized Crossover Study

2016 ◽  
Vol 2016 ◽  
pp. 1-7 ◽  
Author(s):  
Marcela Janka-Zires ◽  
Paloma Almeda-Valdes ◽  
Ana Cecilia Uribe-Wiechers ◽  
Sonia Citlali Juárez-Comboni ◽  
Joel López-Gutiérrez ◽  
...  

Only 30 percent of chronic diabetic foot ulcers heal after 20 weeks of standard treatment. Pirfenidone is a drug with biological, anti-inflammatory, and antifibrotic effects. The aim of this study was to evaluate the effect of topical pirfenidone added to conventional treatment in noninfected chronic diabetic foot ulcers. This was a randomized crossover study. Group 1 received topical pirfenidone plus conventional treatment for 8 weeks; after this period, they were switched to receive conventional treatment only for 8 more weeks. In group 2, the order of the treatments was the opposite. The end points were complete ulcer healing and size reduction. Final data were obtained from 35 ulcers in 24 patients. Fifty-two percent of ulcers treated with pirfenidone healed before 8 weeks versus 14.3% treated with conventional treatment only (P=0.025). Between 8 and 16 weeks, 30.8% ulcers that received pirfenidone healed versus 0% with conventional treatment (P=0.081). By week 8, the reduction in ulcer size was 100% [73–100] with pirfenidone versus 57.5% with conventional treatment [28.9–74] (P=0.011). By week 16, the reduction was 93% [42.7–100] with pirfenidone and 21.8% [8–77.5] with conventional treatment (P=0.050). The addition of topical pirfenidone to conventional treatment significantly improves the healing of chronic diabetic noninfected foot ulcers.

2019 ◽  
Vol 18 (3) ◽  
pp. 262-268 ◽  
Author(s):  
Vladimíra Fejfarová ◽  
Hana Tibenská ◽  
Jitka Niklová ◽  
Robert Bém ◽  
Michal Dubský ◽  
...  

Infections caused by Pseudomonas sp are difficult to resolve by antibiotics (ATBs) and local therapy. The aim of our pilot study was to assess the effect of different local agents—particularly acidifying solutions—on the healing of diabetic foot ulcers (DFUs), eradication of pathogens, and economic costs related to DFU therapy. In this case study, we monitored 32 DFU patients infected by Pseudomonas species. Patients were divided into 2 groups according to the local therapy provided: group 1 (n = 15)—modern local treatment; group 2 (n = 17)—acidifying antiseptic solutions. The study groups differed only with regard to ATB usage prior to enrolment in the study ( P = .004), but did not differ with regard to age, diabetes control, peripheral arterial disease, or microcirculation status. During the follow-up period, DFUs healed in 20% of cases in group 1, but there were no cases of healing in group 2 (NS). The length of ATB therapy, the number of new osteomyelitis, lower limb amputations, and the changes of DFUs status/proportions did not differ significantly between study groups. Pseudomonas was eradicated in 67% of cases in group 1 and in 65% of cases in group 2. The local treatment given to group 2 patients was associated with lower costs ( P < .0001). Conclusion. Acidifying agents had the same effect as modern healing agents on wound healing, the number of amputations, and the eradication of Pseudomonas. Moreover, therapy performed using acidifying solutions proved in our pilot study markedly cheaper.


2021 ◽  
Vol 17 (4) ◽  
pp. 552-556
Author(s):  
V. I. Petrov ◽  
N. V. Rogova ◽  
T. N. Кuzmina ◽  
A. S. Lishuta

Aim. To study changes in epithelialization of diabetic foot ulcers and parameters of laser Doppler flowmetry (LDF) in patients with diabetic foot syndrome (DFS) and atrial fibrillation (AF) during complex therapy with the addition of direct oral anticoagulants (DOAC).Material and methods. An open-label comparative randomized study in parallel groups was performed. Patients with neuroischemic DFS and persistent FA without previous anticoagulant therapy were randomized into two groups: combination therapy for DFS and rivaroxaban (group 1; n=24) or combination therapy for DFS and dabigatran (group 2; n=22). Changes in local status in diabetic foot ulcers, coagulogram parameters and LDF were studied at 4 and 12 weeks.Results. Complete epithelialization of diabetic foot ulcers after 12 weeks was found in 14 (58.3%) patients in group 1, and in 10 (45.4%) patients in group 2. Statistically significant improvements in LDF parameters were found in both groups in both groups: an increase in the microcirculation index by 53.5% (p=0.02), pulse wave by 124.0% (p=0.003), respiratory wave by 59.4% (p=0.007) was found in group 1. An increase in the microcirculation index by 48.5% (p=0.02), pulse wave by 73.1% (p=0.003), respiratory wave by 47.1% (p=0.03) were found in group 2.Conclusion. Positive statistically significant changes in epithelialization of diabetic foot ulcers and LDF parameters were found in patients with DFS and AF during 12 weeks of complex therapy with the addition of DOACs (rivaroxaban and dabigatran). Further research for DOACs in DFS patients is needed.


2019 ◽  
Vol 19 (2) ◽  
pp. 158-164 ◽  
Author(s):  
Vijay Viswanathan ◽  
Udyama Juttada ◽  
Mary Babu

To validate the efficacy of recombinant human epidermal growth factor (hEGH) in healing diabetic foot ulcers (DFUs) at biochemical and molecular levels. A total of 50 noninfected DFU subjects were recruited for the study and divided into 2 groups based on the treatment application on the subjects. Group 1: DFU subjects treated with hEGH gel-based product called Regen-D 150 (n = 27) and group 2: DFU subjects treated with alternative placebo as the control group (n = 23). Patients were observed for 30 days and punch biopsy was taken at days 0 and 14. Histologic analysis was done to study the matrix alignment, cellular infiltration, and differentiation of epithelial layers. Biochemical analysis was done to quantitatively estimate the amount of collagen and proteoglycans regenerated in the wound area. Complete healing of ulcers was observed in 21 (78%) subjects in group 1, whereas only 12 (52%) subjects among group 2 reported of complete healing of ulcer after completion of the study period of 30 days. Collagen and fibroblasts were significantly developed in group 1 when observed in the follow-up samples. Healing time of the wound among the group 1 subjects was significantly less than the group 2 subjects (45 ± 12 vs 72 ± 18 days, P < .0001) and even showed a better blood glucose level. Early and regular application of the hEGH on DFUs will lead to prevention of leg amputations and would serve to act as a major treatment therapy for healing of chronic wounds.


Author(s):  
Lawrence DiDomenico ◽  
Dennis Orgill ◽  
Robert Galiano ◽  
Thomas Serena ◽  
Marissa Carter ◽  
...  

2015 ◽  
Vol 23 (2) ◽  
pp. 203-212 ◽  
Author(s):  
Christina L. Grek ◽  
G.M. Prasad ◽  
Vijay Viswanathan ◽  
David G. Armstrong ◽  
Robert G. Gourdie ◽  
...  

Author(s):  
Silvia M Becerra-Bayona ◽  
Víctor Alfonso Solarte-David ◽  
Claudia L Sossa ◽  
Ligia C Mateus ◽  
Martha Villamil ◽  
...  

Summary Diabetic foot ulcer morbidity and mortality are dramatically increasing worldwide, reinforcing the urgency to propose more effective interventions to treat such a devastating condition. Previously, using a diabetic mouse model, we demonstrated that administration of bone marrow mesenchymal stem cells derivatives is more effective than the use of bone marrow mesenchymal stem cells alone. Here, we used the aforementioned treatments on three patients with grade 2 diabetic foot ulcers and assessed their beneficial effects, relative to the conventional approach. In the present study, two doses of cell derivatives, one dose of mesenchymal stem cells or one dose of vehicle (saline solution with 5% of human albumin), were intradermally injected around wounds. Wound healing process and changes on re-epithelialization were macroscopically evaluated until complete closure of the ulcers. All ulcers were simultaneously treated with conventional treatment (PolyMen® dressing). Patients treated with either cell derivatives or mesenchymal stem cells achieved higher percentages of wound closure in shorter times, relative to the patient treated with the conventional treatment. The cell derivative and mesenchymal stem cells approaches resulted in complete wound closure and enhanced skin regeneration at some point between days 35 and 42, although no differences between these two treatments were observed. Moreover, wounds treated with the conventional treatment healed after 161 days. Intradermal administration of cell derivatives improved wound healing to a similar extent as mesenchymal stem cells. Thus, our results suggest that mesenchymal stem cell derivatives may serve as a novel and potential therapeutic approach to treat diabetic foot ulcers. Learning points: In diabetic mouse models, the administration of mesenchymal stem cells derivatives have been demonstrated to be more effective than the use of marrow mesenchymal stem cells alone. Mesenchymal stem cells have been explored as an attractive therapeutic option to treat non-healing ulcers. Mesenchymal stem cells derivatives accelerate the re-epithelialization on diabetic foot ulcers.


Author(s):  
Hemanth Boppana

The widespread use of the tetanus toxoid vaccine has been very effective in the prevention of tetanus. However, older patients who may have failed to receive or complete immunization schedules for this vaccine are prone to the significant risks of this life-threatening illness. We present two cases stemming from diabetic foot ulcers to remind clinicians of the presentation and treatment of this now rare disease and to also draw attention to the need to emphasize immunisation as a prevention strategy.


2015 ◽  
Vol 18 (3) ◽  
pp. 70-76 ◽  
Author(s):  
Elena Yurievna Komelyagina ◽  
Evgenia Aleksandrovna Kogan ◽  
Mikhail Borisovich Antsiferov

Aim. To compare the clinical and morphological characteristics of chronic diabetic foot ulcers and the markers of repair.Materials and Methods.We included 26 patients with neuropathic diabetic foot syndrome who had signs of severe peripheral neuropathy. Biopsies were performed from the margin and central part of the lesion and were fixed in a 10% formalin solution before being placed on paraffin slides and stained with hematoxylin and eosin. We assessed the percentages of necrotic, granulation and fibrotic tissues and the severity of vascular hyalinosis. Immunohistochemistry was performed with initial antibodies to Ki-67 (a marker of proliferation), smooth muscle actin (a marker of myofibroblast synthesis) and cytokeratin (a marker of epithelisation). For analysis, the samples were divided into three groups by the length of time the ulcer had been present: group 1 (≤90 days; 9 samples), group 2 (91–365 days; 10 samples) and group 3 (365 days; 9 samples).Results. The patients of group 3 were older than those of groups 1 and 2 (53.7±2.7 vs 51.7±5.9 vs 59.9±5.6 years; p=0.04). There were no differences in the duration of diabetes, glycated haemoglobin or severity of neuropathy. The percentage of necrotic tissue was higher in group 1 (33.7%±21.7% vs 11.0%±3.9% vs 12.8%±6.1%; p=0.02) and the percentage of fibrotic tissue was highest in group 3 (21.1%±21.0% vs 35.5%±19.8% vs 54.4%±23.9%; p=0.001). However, the amount of granulation tissue was not different between the groups (45.2%±21.1% vs 53.5%±21.1% vs 32.8%±26.3%; p=0.4). There was also no difference in the severity of vascular hyalinosis between the groups (p=0.9). Expression of Ki-67 was higher in groups 1 and 2, implying a greater capacity to regenerate. The expression of smooth muscle actin and cytokeratin was higher in groups 1 and 2 but without statistical significance.Conclusion. The morphological characteristics and regenerative capacities of neuropathic diabetic foot ulcers differ with the duration the ulcer has been present. Patients with ulcers for less than 1 year were characterised by higher cell proliferation but lower fibrosis. Neuropathic diabetic foot ulcers that are unable to heal over a year are characterised by incomplete regeneration and higher levels of fibrosis. Thus, different treatment approaches are needed depending on how long an ulcer has been present.


2020 ◽  
Vol 9 (12) ◽  
pp. 3807
Author(s):  
Enea Gino Di Domenico ◽  
Barbara De Angelis ◽  
Ilaria Cavallo ◽  
Francesca Sivori ◽  
Fabrizio Orlandi ◽  
...  

Infections are among the most frequent and challenging events in diabetic foot ulcers (DFUs). Pathogenic bacteria growing in biofilms within host tissue are highly tolerant to environmental and chemical agents, including antibiotics. The present study was aimed at assessing the use of silver sulfadiazine (SSD) for wound healing and infection control in 16 patients with DFUs harboring biofilm-growing Staphylococcus aureus and Pseudomonas aeruginosa. All patients received a treatment based on a dressing protocol including disinfection, cleansing, application of SSD, and application of nonadherent gauze, followed by sterile gauze and tibio-breech bandage, in preparation for toilet surgery after 30 days of treatment. Clinical parameters were analyzed by the T.I.M.E. classification system. In addition, the activity of SSD against biofilm-growing S. aureus and P. aeruginosa isolates was assessed in vitro. A total of 16 patients with S. aureus and P. aeruginosa infected DFUs were included in the study. Clinical data showed a statistically significant (p < 0.002) improvement of patients’ DFUs after 30 days of treatment with SSD with significant amelioration of all the parameters analyzed. Notably, after 30 days of treatment, resolution of infection was observed in all DFUs. In vitro analysis showed that both S. aureus and P. aeruginosa isolates developed complex and highly structured biofilms. Antibiotic susceptibility profiles indicated that biofilm cultures were significantly (p ≤ 0.002) more tolerant to all tested antimicrobials than their planktonic counterparts. However, SSD was found to be effective against fully developed biofilms of both S. aureus and P. aeruginosa at concentrations below those normally used in clinical preparations (10 mg/mL). These results strongly suggest that the topical administration of SSD may represent an effective alternative to conventional antibiotics for the successful treatment of DFUs infected by biofilm-growing S. aureus and P. aeruginosa.


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