Clinical performance evaluation of a newly developed sock for people with diabetes

2021 ◽  
pp. 095441192110020
Author(s):  
Berna Cüreklibatır Encan ◽  
Arzu Marmaralı ◽  
Dilek Bayraktar ◽  
Şevki Çetinkalp ◽  
Ilgın Yıldırım Şimşir
Keyword(s):  
Diabetic Foot ◽  
Plantar Pressure ◽  
Clinical Performance ◽  
Fungal Infections ◽  
Callus Formation ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Metatarsal Bones ◽  
Patients With Diabetes ◽  
Diabetic Wounds

Diabetes mellitus (DM) is a chronic disease that has become a global health problem. As the population of people with diabetes is growing worldwide, the prevalence of complications associated with DM, such as diabetic foot, also increases. Neuropathy and high plantar pressure are the two most frequent causes of foot ulceration. Since diabetic wounds tend to heal slowly, it is crucial to prevent diabetic foot ulcers before they occur. In this study, the efficacy of a sock developed for diabetes in the previous research of the authors was investigated in a clinical study with the participation of patients with diabetes over a 6-month period. At the end of the study, it was observed that none of the participants had experienced any new ulcers, bacterial or fungal infections, or callus formation during this research. Moreover, a slight decrease in pressure was observed for the first, second, and third metatarsal bones when the socks were worn on day 1. On the other hand, pressure reduction was identified for the fourth and fifth metatarsal bones in all following measurements. However, analyses revealed that duration of usage did not have a statistically significant effect on overall plantar pressure. It was also found that pressure on the fourth and fifth metatarsal bones significantly decreased. Assessment of wearing comfort revealed the satisfaction of the patients, as well. Based on the promising outcomes of this clinical evaluation, these socks developed for people with diabetes can be strongly expected to help avoid diabetic foot ulcers.

scholarly journals Preliminary Evaluation of a Cycling Cleat Designed for Diabetic Foot Ulcers

2017 ◽  
Vol 107 (6) ◽  
pp. 475-482 ◽  
Author(s):  
Ryan T. Crews ◽  
Steven R. Smith ◽  
Ramin Ghazizadeh ◽  
Sai V. Yalla ◽  
Stephanie C. Wu
Keyword(s):  
Blood Flow ◽  
Diabetic Foot ◽  
Plantar Pressure ◽  
Tissue Perfusion ◽  
Foot Ulcers ◽  
Preliminary Evaluation ◽  
Diabetic Foot Ulcers ◽  
Time Integral ◽  
Traditional Health ◽  
Before And After

Background: Offloading devices for diabetic foot ulcers (DFU) generally restrict exercise. In addition to traditional health benefits, exercise could benefit DFU by increasing blood flow and acting as thermotherapy. This study functionally evaluated a cycling cleat designed for forefoot DFU. Methods: Fifteen individuals at risk of developing a DFU used a recumbent stationary bicycle to complete one 5-minute cycling bout with the DFU cleat on their study foot and one 5-minute bout without it. Foot stress was evaluated by plantar pressure insoles during cycling. Laser Doppler perfusion monitored blood flow to the hallux. Infrared photographs measured foot temperature before and after each cycling bout. Results: The specialized cleat significantly reduced forefoot plantar pressure (9.9 kPa versus 62.6 kPa, P < .05) and pressure time integral (15.4 versus 76.4 kPa*sec, P < .05). Irrespective of footwear condition, perfusion to the hallux increased (3.97 ± 1.2 versus 6.9 ± 1.4 tissue perfusion units, P < .05) after exercise. Infrared images revealed no changes in foot temperature. Conclusions: The specialized cleat allowed participants to exercise with minimal forefoot stress. The observed increase in perfusion suggests that healing might improve if patients with active DFU were to use the cleat. Potential thermotherapy for DFU was not supported by this study. Evaluation of the device among individuals with active DFU is now warranted.

Plantar Pressures, Plantar Forces, and Their Influence on the Pathogenesis of Diabetic Foot Ulcers

2013 ◽  
Vol 103 (4) ◽  
pp. 322-332 ◽  
Author(s):  
Jérôme Patry ◽  
Richard Belley ◽  
Mario Côté ◽  
Marie-Ludivine Chateau-Degat
Keyword(s):  
Shear Stress ◽  
Mechanical Stress ◽  
Diabetic Foot ◽  
Threshold Value ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Plantar Pressures ◽  
Manual Search ◽  
Patients With Diabetes ◽  
Full Text Review

Background: Clinical recommendations for the prevention and healing of diabetic foot ulcers (DFUs) are somewhat clear. However, assessment and quantification of the mechanical stress responsible for DFU remain complex. Different pressure variables have been described in the literature to better understand plantar tissue stress exposure. This article reviews the role of pressure and shear forces in the pathogenesis of plantar DFU. Methods: We performed systematic searches of the PubMed and Embase databases, completed by a manual search of the selected studies. From 535 potentially relevant references, 70 studies were included in the full-text review. Results: Variables of plantar mechanical stress relate to vertical pressure, shear stress, and temporality of loading. At this time, in-shoe peak plantar pressure (PPP) is the only reliable variable that can be used to prevent DFU. Although it is a poor predictor of in-shoe PPP, barefoot PPP seems complementary and may be more suitable when evaluating patients with diabetes mellitus and peripheral neuropathy who seem noncompliant with footwear. An in-shoe PPP threshold value of 200 kPa has been suggested to prevent DFU. Other variables, such as peak pressure gradient and peak maximal subsurface shear stress and its depth, seem to be of additional utility. Conclusions: To better assess the at-risk foot and to prevent ulceration, the practitioner should integrate quantitative models of dynamic foot plantar pressures, such as in-shoe and barefoot PPPs, with the regular clinical screening examination. Prospective studies are needed to evaluate causality between other variables of mechanical stress and DFUs. (J Am Podiatr Med Assoc 103(4): 322–332, 2013)

Maggot debridement therapy to treat hard-to-heal diabetic foot ulcers: a single-centre study

2021 ◽  
Vol 30 (Sup12) ◽  
pp. S30-S36
Author(s):  
Harikrishna KR Nair ◽  
Nazni Wasi Ahmad ◽  
AA Ismail ◽  
Ali A Alabed ◽  
Benjamin Oh Zheming ◽  
...  
Keyword(s):  
Diabetic Foot ◽  
Case Series ◽  
Cost Effective ◽  
Lucilia Cuprina ◽  
Study Endpoint ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Necrotic Tissue ◽  
Maggot Debridement Therapy ◽  
Diabetic Wounds

Objective: Maggot debridement therapy (MDT) has seen a resurgence in recent years in the treatment of hard-to-heal wounds, as a result of rising antibiotic resistance. The sterilised larvae of Lucilia cuprina have been used in MDT in Malaysia since 2003, with encouraging results for the treatment of hard-to-heal diabetic wounds. We report a case series of 30 patients selected from our clinic by convenient sampling with diabetic lower limb ulcers treated with MDT. The average age of patients receiving MDT was >50 years. Of the 30 patients in the study, nine were female and 21 were male. All patients had underlying diabetes, two patients had leg ulcers and 28 patients had diabetic foot ulcers. Sterilised Lucilia cuprina larvae were applied via a standard method of 10 maggots per square centimetre and dressed with sterile gauze. The study endpoint was defined as ≤5% coverage with slough or necrotic tissue following three successive applications of MDT. In this study, maximum debridement of wounds was achieved in 96.6% (29 patients) of our patients, with ≤5% coverage with slough or necrotic tissue, in addition to a reduction in wound-related pain, as assessed by a visual analogue scale. No adverse events were reported. The findings of this study support the use of MDT as a safe, efficacious, and cost-effective method of managing diabetic wounds.

scholarly journals Biofilms in Diabetic Foot Ulcers: Significance and Clinical Relevance

2020 ◽  
Vol 8 (10) ◽  
pp. 1580
Author(s):  
Cassandra Pouget ◽  
Catherine Dunyach-Remy ◽  
Alix Pantel ◽  
Sophie Schuldiner ◽  
Albert Sotto ◽  
...  
Keyword(s):  
Diabetic Foot ◽  
Biofilm Formation ◽  
Chronic Infection ◽  
Current Knowledge ◽  
Bacterial Species ◽  
Limb Amputation ◽  
Foot Ulcers ◽  
Main Role ◽  
Diabetic Foot Ulcers ◽  
Patients With Diabetes

Foot infections are the main disabling complication in patients with diabetes mellitus. These infections can lead to lower-limb amputation, increasing mortality and decreasing the quality of life. Biofilm formation is an important pathophysiology step in diabetic foot ulcers (DFU)—it plays a main role in the disease progression and chronicity of the lesion, the development of antibiotic resistance, and makes wound healing difficult to treat. The main problem is the difficulty in distinguishing between infection and colonization in DFU. The bacteria present in DFU are organized into functionally equivalent pathogroups that allow for close interactions between the bacteria within the biofilm. Consequently, some bacterial species that alone would be considered non-pathogenic, or incapable of maintaining a chronic infection, could co-aggregate symbiotically in a pathogenic biofilm and act synergistically to cause a chronic infection. In this review, we discuss current knowledge on biofilm formation, its presence in DFU, how the diabetic environment affects biofilm formation and its regulation, and the clinical implications.

The Physical Characteristics of Materials Used in the Manufacture of Orthoses for Patients with Diabetes

2007 ◽  
Vol 28 (10) ◽  
pp. 1057-1063 ◽  
Author(s):  
Joanne Paton ◽  
Ray B. Jones ◽  
Elizabeth Stenhouse ◽  
Graham Bruce
Keyword(s):  
Physical Properties ◽  
Diabetic Foot ◽  
Performance Indicator ◽  
Practical Method ◽  
Relevant Information ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Patients With Diabetes ◽  
Properties Of Materials ◽  
Materials Used

Background: Neuropathic diabetic foot ulceration may be prevented if the mechanical stress transmitted to the plantar tissues can be modified. Orthotic therapy is one practical method commonly used to maintain tissue integrity. Orthotic design must consider the materials chosen for use in fabrication and profile of the device because both aspects influence the performance and durability of the device. Published research evaluating the physical properties of materials commonly used in the manufacture of orthoses for patients with diabetes is limited. This study investigated the physical properties of materials used to fabricate orthoses designed for the prevention of neuropathic diabetic foot ulcers. Methods: Fifteen commonly used orthotic materials were selected for testing: four specifications of 6.4-mm Poron® (Rogers Corp., Gent, Belgium), 3.2-mm Poron®, three densities of 12-mm Ethylene Vinyl Acetate (EVA), 12-mm low-density plastazote, two depths (6.4-mm, 3.2-mm) of Cleron™ (Algeo Ltd., Liverpool, UK), Professional Protective Technology (PPT), and MaxaCane (Algeo Ltd, Liverpool, UK). The density, resilience, stiffness, static coefficient of friction, durability, and compression set of each material were tested, ranked, and allocated a performance indicator score. Results: The most clinically desirable dampening materials tested were Poron® 96 (6-mm) and Poron® 4000 (6-mm). High density EVA (Algeo Ltd., Liverpool, UK) and Lunacell Nora® EVA (Freudenberg, Weinhein, Germany) possessed the properties most suitable to achieve motion control. The data present a simple and useful comparison and classification of the selected materials. Conclusions: Although this information should not be used as a single indicator for assessing the suitability of an orthotic material, the results provide clinically relevant information relating to the physical properties of orthotic materials commonly used in the prevention of neuropathic diabetic foot ulcers.

scholarly journals Toward Machine-Learning-Based Decision Support in Diabetes Care: A Risk Stratification Study on Diabetic Foot Ulcer and Amputation

2021 ◽  
Vol 7 ◽  
Author(s):  
Zeinab Schäfer ◽  
Andreas Mathisen ◽  
Katrine Svendsen ◽  
Susanne Engberg ◽  
Trine Rolighed Thomsen ◽  
...  
Keyword(s):  
Machine Learning ◽  
Risk Factors ◽  
Diabetic Foot ◽  
National Registry ◽  
Registry Data ◽  
Data Sources ◽  
Machine Learning Techniques ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Patients With Diabetes

Diabetes mellitus is associated with serious complications, with foot ulcers and amputation of limbs among the most debilitating consequences of late diagnosis and treatment of foot ulcers. Thus, prediction and on-time treatment of diabetic foot ulcers (DFU) are of great importance for improving and maintaining patients' quality of life and avoiding the consequent socio-economical burden of amputation. In this study, we use Danish national registry data to understand the risk factors of developing diabetic foot ulcers and amputation among patients with diabetes. We analyze the data of 246,705 patients with diabetes to assess some of the main risk factors for developing DFU/amputation. We study the socioeconomic information and past medical history of the patients. Factors, such as low family disposable income, cardiovascular disorders, peripheral artery, neuropathy, and chronic renal complications are among the important risk factors. Mental disorders and depression, albeit not as pronounced, still pose higher risks in comparison to the group of people without these complications. We further use machine learning techniques to assess the practical usefulness of such risk factors for predicting foot ulcers and amputation. Finally, we outline the limitations of working with registry data sources and explain potentials for combining additional public and private data sources in future applications of artificial intelligence (AI) to improve the prediction of diabetic foot ulcers and amputation.

scholarly journals Impact of diabetic (diabetes mellitus) patients immune factors on the skin cell viability in vitro

2020 ◽  
Vol 17 (3) ◽  
pp. 263-274
Author(s):  
M. A. Mashkova ◽  
T. V. Mokhort ◽  
V. A. Goranov
Keyword(s):  
Diabetes Mellitus ◽  
Diabetic Foot ◽  
Culture System ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Skin Culture ◽  
Patients With Diabetes ◽  
Immune Factors ◽  
3D Skin

At the moment, a lot of scientific research focused on the role of immune mechanisms in diabetic foot ulcers development and impaired healing. A 3D skin culture system as a relevant skin model may prove valuable in investigating these mechanisms and may be a useful tool to study interactions between different cell types such as keratinocytes, fibroblasts, and immune cells. The aim of our research was to study keratinocytes and fibroblasts viability in co-culture with immune factors of patients with diabetes mellitus type 2 (DM2) and patients with diabetes and chronic foot ulcers in a 3D skin culture system. In this study, the multilayer 3D immunocompetent model of human skin comprising keratinocytes, fibroblasts, and mononuclears in an agarose-fibronectin gel was used. The human immortalized keratinocyte cell line, HaCaT, and primary fibroblast cell culture isolated from skin samples of healthy man in abdominal surgery were used for the 3D system. For the experiment 20 % serum of 9 patients with chronic diabetic foot ulcers (without active inflammation signs), 9 diabetic type 2 patients and 9 healthy people, and mononuclears of the same groups of patients were used. 9 experimental series with 3 repeats were carried out. Mononuclears of patients with DM2 and DM2 and diabetic foot syndrome (DFS) had a greater inhibitory effect on fibroblasts, significantly inhibiting their proliferation to a level of 83.78 [79.03; 89.53] % vs 70.18 [66.38; 72.10] % vs 95.40 [91.75; 99.05] %, H = 21.259, p <0.001 – DM2, DFS, and the control group, respectively. There was no significant difference in the cytoinhibitory effect of mononuclears on keratinocytes between different groups: 96.40 [92.82; 100.50] % vs 93.61 [86.80; 97.10] % vs 92.87 [85.15; 95.25] %, H = 4.459, p = 0.108 – control, DM2 and DFS group, respectively. Adding serum to the culture system influenced significantly the viability of neither keratynocytes – 99.40 [95.35; 102.05]  % vs 98.60 [90.55; 100.40] % vs 94.79 [91.65; 98.16] %, H = 3.030, p = 0.220 nor of fibroblasts – 95.61 [92.39; 100.19] % vs 95.80 [88.99; 102.15] % vs 96.20 [99.69; 88.70] %, H = 0.353, p = 0.838, control, DM2 and DFS group, respectively. It was determined that the fibroblasts vialability significantly decreases after introducing mononuclears of patients with DM and patients with DM and chronic diabetic foot ulcers to the co-culture system. Adding serum of these patient groups to the culture system doesn’t influence significantly the viability of skin cells.

Bacterial Prevalence and Antibiotic Resistance in Clinical Isolates of Diabetic Foot Ulcers in the Northeast of Tamaulipas, Mexico

2017 ◽  
Vol 16 (2) ◽  
pp. 129-134 ◽  
Author(s):  
Mario Sánchez-Sánchez ◽  
Wendy Lizeth Cruz-Pulido ◽  
Eduardo Bladinieres-Cámara ◽  
Rodrigo Alcalá-Durán ◽  
Gildardo Rivera-Sánchez ◽  
...  
Keyword(s):  
Diabetic Foot ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Gram Positive ◽  
Phenotypic Resistance ◽  
Gram Positive Bacteria ◽  
Patients With Diabetes ◽  
Muscle Biopsies ◽  
Extremity Amputation ◽  
Gram Positive Cocci

Diabetic foot ulcers (DFUs) are a serious and common problem in patients with diabetes mellitus and constitute one of the major causes of lower extremity amputation. The microbiological profile of DFUs depends on the acute or chronic character of the wound. Aerobic gram-positive cocci are the predominant organisms isolated from DFUs. Diabetic foot biopsies from patients admitted to the Angiology and Vascular Surgery Hospital of the Northeast, in Reynosa, Tamaulipas from December 2011 to April 2016 were analyzed. The samples were processed using standard microbiology techniques. Antimicrobial susceptibility testing was carried out according to the protocol established by the Clinical & Laboratory Standards Institute (CLSI). We obtained 246 bacterial isolates, based on the results of phenotypic resistance. The least effective antibiotics for gram-positive bacteria were penicillin and dicloxacillin; for gram-negative bacteria, cefalotin and penicillin were the least effective. Levofloxacin, cefalotin, and amikacin were the most effective antibiotics for gram-positive and negative bacteria, respectively. Enterobacter genus was significantly associated with muscle biopsies ( P = .011) and samples without growth were significantly associated with specimens of pyogenic origin ( P = .000). In 215 DFU samples, we found that Staphylococcus aureus was the most commonly isolated pathogen followed by Enterobacter sp. This is consistent with previous reports. Enterobacter species may play an important role in the colonization/infection of certain tissues; however, further studies are needed in this regard.

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