Neuropathic Diabetic Foot Research Articles

Microbiological characterization of neuropathic diabetic foot infection: a retrospective study at a Portuguese tertiary hospital

Diabetic foot infection imposes a significant burden and is the major cause of nontraumatic limb amputation. Adequate patient management with effective antibiotic therapy is crucial.This retrospective cohort study aimed to characterize the microbiology and resistance patterns of moderate to severe neuropathic diabetic foot infection in patients hospitalized at a tertiary referral hospital between January 2020 and June 2023. Deep tissue specimens from ulcers were collected for culture.Sixty inpatients were included (62% male, mean age 59.1 ± 11.5 years). Osteomyelitis was present in 90% of the patients. Among 102 microorganisms (average of 1.91 ± 1.25 pathogens per patient), 60.8% were gram-positive bacteria, 31.4% were gram-negative, 3.92% were anaerobic bacteria, and 3.92% were fungi. Staphylococcus aureus (19%) and Enterococcus faecium (17%) were the most common. Pseudomonas aeruginosa (8%) and bacteria of the Enterobacterales family (24%) accounted for all the isolated gram-negative bacteria. Sixteen percent of Staphylococcus aureus and 67% of coagulase-negative Staphylococci were resistant to methicillin. Resistance to ampicillin was found in 11% of Enterococci. All Pseudomonas aeruginosa isolates were sensitive to piperacillin-tazobactam, ceftazidime, or cefepime. Among the Enterobacterales, resistance rates were 35% for piperacillin-tazobactam, 38% for ceftazidime, 21% for cefepime, and 13% for carbapenems.Although the prevalence of methicillin-resistant staphylococci was lower than that in other studies, carbapenem resistance among gram-negative bacteria warrants attention. This study highlights the importance of understanding local epidemiology for effective diabetic foot infection management and resistance mitigation.

Effectiveness of different advanced wound dressings versus standard of care for the management of diabetic foot ulcers: a meta-analysis of randomized controlled trials for the development of the Italian guidelines for the treatment of diabetic foot syndrome.

to assess the effects of advanced wound dressings (AWD) commonly used in the treatment of predominantly neuropathic diabetic foot ulcers (DFU) The present meta-analysis was designed to support the development of the Italian Guidelines for the Treatment of Diabetic Foot Syndrome (DFS). A Medline and Embase search were performed up to April 1st, 2024 collecting all RCTs including diabetic patients or reporting subgroup analyses on diabetic patients with DFU comparing AWD with placebo/standard of care (SoC), with a duration of at least 12 weeks. Prespecified endpoints were: ulcer healing (principal), time-to-healing, frequency of dressings change, major and minor amputation, pain, and all-cause mortality. AWD assessed were: alginates; foam, hydrocolloids, hydrogels, hyaluronic acid, hemoglobin spray, silver-impregnated, sucrose octasulfate-impregnated, honey-impregnated, micro-organism-binding, and protease-modulating matrix dressings. Mantel-Haenzel Odds ratios and 95% confidence intervals (MH-OR, 95% CIs) were either calculated or extracted directly from the publications. Weighted mean differences (WMD) and 95% CIs were calculated for continuous variables. Fifteen studies fulfilled all inclusion criteria. Participants treated with AWD had a significantly higher ulcer healing rate and shorter time-to-healing in comparison with SoC/placebo (MH-OR 1.50 [0.80, 2.79], p = 0.20 and WMD:: - 24.38 [- 42.90, - 5.86] days, p = 0.010). No other significant effect on the above reported prespecified endpoints were observed. For the primary endpoint, the quality of evidence was rated as "moderate". In conclusion, AWD, particularly sucrose-octasulfate, hydrogels, hyaluronic acid, and honey dressings, can actively promote wound healing and shortening time-to-healing in patients with DFU.

Evaluating the Efficacy of Topical Phenytoin in the Healing of Neuropathic Diabetic Foot Ulcers: A Comparative Study.

This study aims to observe the outcomes of topical phenytoin treatment in healing neuropathic diabetic foot ulcers with mild infection and compare these outcomes with those obtained from conventional dressing methods. A retrospective observational study was conducted by reviewing the medical records of patients with neuropathic diabetic foot ulcers treated at a tertiary care center from 2015 to 2020. Two groups were identified: (1) patients treated with topical phenytoin (for ulcers measuring less than 5 cm, a dosage of 100 mg was used; for ulcers measuring between 5 cm and 9 cm, a dosage of 150 mg was used; for ulcers measuring between 10 cm and 15 cm, a dosage of 200 mg was used; and for ulcers measuring greater than 15 cm, a dosage of 300 mg was used. The tablets were crushed and dispersed before administration) and (2) those were treated with conventional dressings (the conventional method includes wound wash with 0.9 normal saline and betadine solution with application of sterile gauze dressing). Data on wound healing rate, time to achieve complete healing, and recurrence rates were collected. The study included 120 patients, with 60 receiving topical phenytoin and 60 receiving conventional dressings. Preliminary findings indicated that the topical phenytoin group experienced a 27 (45%) reduction in ulcer size by week four, compared to a 15 (25%) reduction in the conventional group. The median time to complete healing was significantly shorter in the phenytoin group (eight weeks) compared to the conventional dressing group (12 weeks; p < 0.05). Additionally, granulation tissue appeared earlier in the phenytoin group, with an average onset of 10 days, compared to 18 days in the conventional group (p < 0.01). The incidence of ulcer recurrence was lower in the phenytoin group (6, 10%) compared to the conventional group (18, 30%; p < 0.05). Topical phenytoin demonstrated a promising enhancement in the healing of mildly infected neuropathic diabetic foot ulcers compared to conventional dressings. Further studies are recommended to substantiate these findings and explore the mechanisms underlying the observed benefits.

Offloading systems for the treatment of neuropathic foot ulcers in patients with diabetes mellitus: a meta-analysis of randomized controlled trials for the development of the Italian guidelines for the treatment of diabetic foot syndrome.

To compare the effectiveness of commonly used offloading devices for the treatment of neuropathic foot ulcers in patients with diabetes mellitus. This meta-analysis (MA) has been performed for giving an answer to clinical questions on this topic of the Italian guideline on diabetic foot syndrome. The present MA includes randomized controlled studies (duration > 12weeks) comparing, in patients with diabetes mellitus and non-infected neuropathic foot ulcer: any offloading device vs either no offloading device or conventional footwear; removable versus non-removable offloading devices; surgical procedure vs other offloading approaches. The primary endpoint was ulcer healing. A total of 184 studies were identified, and 18 were considered eligible for the analysis. We found that: any plantar off-loading, when compared to the absence of plantar offloading device, is associated with a higher ulcer healing (MH-OR: 3.13 [1.08, 9.11], p = 0.04, I2 = 0%); total contact cast or nonremovable knee-high walker, compared to other offloading devices, had a higher ulcer healing rate (MH-OR: 2.64 [1.43, 4.89], p = 0.002, I2 = 51%); surgical offloading for active ulcers in combination with post-surgery offloading achieves higher ulcer healing rate when compared to offloading devices alone (MH-OR: 6.77 [1.64, 27.93], p = 0.008, I2 = 0%). Any plantar offloading, compared to the absence of plantar offloading device, is associated with a higher ulcer healing rate. Total contact cast or nonremovable knee-high walker, compared to other offloading devices, is preferable. Surgical offloading for active ulcers, in combination with post-surgery offloading devices, achieves a higher ulcer healing rate when compared to other offloading devices alone. Further studies with a larger cohort of patients with diabetic neuropathic foot ulcers and extended follow-up periods are necessary.

Comparison Between Conservative and Operative Management of Diabetic Foot Having Bone Involvement

Objective: To compare the efficacy of conservative and operative management of diabetic foot having bone involvement. Study Design: Quasi-experimental study. Place and Duration of study: Combined Military Hospital, Rawalpindi Pakistan, from May to Dec 2022. Methodology: The study included all the patients with neuropathic diabetic foot ulcers worsened by bone involvement/osteomyelitis. All the included patients were divided randomly into two equal groups, A and B (Conservative and Operative Management Groups, respectively). They were followed up for the study period to assess the healing of the wound. All the participants of the study were given antibiotics. Outcome measures were the proportion of patients achieving primary wound healing, hospitalization time, and wound healing time. Results: In our study, we included 302 patients, amongst which 206(68.20%) were male subjects and 96(31.80%) were female subjects. The mean age was 33.89±7.57 years. The proportion of patients achieving primary wound healing in the Conservative Management-Group was 121(80.13%), and in the Operative Management-Group, it was 132(87.42%) (p=0.086). However, the difference between the duration of hospitalization and the time of wound healing was statistically insignificant (p-values of 0.199 and 0.538, respectively). Conclusion: Conservative management with antibiotics alone may be a good alternative to operative management, avoiding surgical complications and costs.

Neuropathic diabetic foot ulcers in the elderly: clinical outcomes and healing

There is little evidence on healing outcomes of neuropathic foot ulcers in elderly patients. Aims: To determine the healing rates of neuropathic diabetic foot ulcers at 12 and 24 weeks achieved by standard care provided at an established multidisciplinary diabetes foot clinic in patients aged 65 years and above. Data on the incidence of falls and hypoglycaemia were also collected due to their perceived clinical risk in the group studied. Methods: This was a retrospective observational study looking at clinical outcomes of neuropathic foot ulcers. Patients aged 65 years or more presenting with a non-infected neuropathic ulcer at the time of their initial review were identified and classified into two groups: Group E patients were aged above 80 years and Group Y patients 65-80 years. Results: A total of 97 patients, presenting with 106 ulcer episodes, were identified. Mean HbA1c was 60 mmol/mol in Group Y and 55 mmol/mol in Group E. Healing rates of all ulcers at 12 and 24 weeks in the elderly group lagged behind rates in the younger group (67.6% at 12 weeks and 73% at 24 weeks in Group E vs. 78.2% at both intervals in Group Y). The elderly group had more falls, 11% vs. 2% in Group Y. In all, 50% of the falls in Group E were attributed to their prescribed pressure relief (off-loading) devices. Conclusions: With standard foot care given in a multi- disciplinary foot service, neuropathic diabetic foot ulcers can heal in the elderly despite their age-related skin changes. The rate of healing of neuropathic ulcers noted in our study provides a benchmark for healing outcomes and enables comparison with other age groups and centres. Our study identifies a risk of falls associated with off-loading devices and highlights the need for structured falls risk and mobility assessments in this group.

The effect of autologous plasminogen on the rate of healing of chronic skin ulcers in patients with diabetes mellitus and the level of proteins - markers of hypoxia and angiogenesis

chronic diabetic wounds are a complication of diabetes mellitus that develop as a result of the toxic effects of hyperglycemia, which leads to metabolic disorders with the development of immunosuppression, angiopathy, and neuropathy. A considerable amount of experimental data has been accumulated, which indicates that the participation of the plasminogen-plasmin system in wound healing is not only to clear wounds of fibrin clots, but also to fine-tune the activity of cells that ensure an adequate course of all stages of healing. This study was conducted to investigate the effect of autologous plasminogen on the rate of chronic wound healing in patients with diabetic foot syndrome. The study involved 45 patients with purulent necrotic form of diabetic foot. The efficacy of topical application of standard medications was compared with the application of autologous plasminogen. The wound area was measured once every two days until complete healing. To study the molecular mechanisms of plasminogen effect on wound healing, the level of marker proteins of key physiological processes associated with healing, namely hypoxia and angiogenesis, was determined. The levels of protein regulators of angiogenesis (vascular endothelial cell growth factor (VEGF), hypoxia-inducible factor-1α (HIF-1α) and angiostatins) in the skin tissue of wounds at the beginning and end of treatment with autologous plasminogen in patients with chronic diabetic wounds with neuropathic diabetic foot were evaluated. The levels of VEGF, HIF-1α and angiostatins were determined by Western blotting. We have found that wound tissue in patients with chronic diabetic wounds before treatment is characterized by a reduced level of VEGF, which represents the inability of these wounds to regenerate. At the same time, an increased level of HIF-1α and angiostatins is detected. After treatment with autologous plasminogen applications, a significant increase in VEGF expression was observed against the background of a progressive decrease in HIF-1α and angiostatin activity. The results indicate that increased production of angiogenic inhibitors may counteract angiogenesis and contribute to the failure of chronic wound healing. The use of plasminogen applications reduces the level of angiostatins in wound biopsies, which allowed to increase the level of proangiogenic factors. Treatment with plasminogen demonstrated an improvement in the condition of the wound surface and the transition of healing to the proliferative phase due to the initiation of the inflammatory process in wounds. The results of planimetric measurement of the wound area indicate a 5-fold reduction in the time required for complete wound healing in the group receiving plasminogen applications compared to this parameter in the comparison group.

Growth factors and their receptors in neuropathic diabetic foot ulcers of different durations

BACKGROUND. Growth factors play a leading role in wound healing. Their deficiency in diabetic foot syndrome has been demonstrated in experimental studies, most of them performed on acute wounds. At the same time, currently the effectiveness of local therapy with growth factors of this category of patients, as well as indications and contraindications to it are contradictory and are a subject for discussion. There is no data on the content of growth factors in diabetic foot ulcers of various durations. Meanwhile, the results obtained will help to expand the understanding of the pathogenetic mechanisms of the course and outcomes of diabetic foot ulcers at different stages of healing.AIM: To evaluate the level of growth factors and their receptors in non-healing neuropathic diabetic foot ulcers of different duration.MATERIALS AND METHODS. 89 samples of neuropathic diabetic foot ulcers were examined. Immunohistochemical analysis of biopsies was performed using antibodies to the following growth factors and their receptors: vascular endothelial growth factor (VEGF), insulin-like growth factor (IGF), epidermal growth factor (EGF). Depending on the duration of the wound, the biopsies were divided into 3 groups: group 1 — ≤ 90 days, group 2 — 91-365 days, group 3 — &gt; 365 days.RESULTS. In the samples of wounds, the duration of which did not exceed 90 days, the expression of growth factors and receptors to them was significantly higher than in wounds of longer duration (p=0.0001). There was no significant difference in quantitative indicators of the expression of growth factors and their receptors between wounds lasting from 91 to 365 days and more than 365 days. According to the data of correlation analysis, the expression of VEGF, IGF, EGF and their receptors has a significant negative dependence on the duration of the wound (p= 0.0001).CONCLUSION. In diabetic foot ulcers lasting less than 90 days, the expression of growth factors such as VEGF, IGF, EGF and their receptors is significantly higher than in wounds of longer duration. The dependence of the expression of growth factors on the duration of the ulcer was revealed. The data obtained may explain the differences in the outcomes of chronic wounds and the absence in some cases of the effect of local therapy with growth factors.

RISK OF NON-HEALING IN ISCHEMIC VERSUS NEUROPATHIC DIABETIC FOOT ULCERS IN RELATION TO GRADE, STAGE OF INFECTION AND TREATMENT PROTOCOL: A FOLLOW-UP STUDY

Background &amp; Objectives: Diabetic foot ulcer (DFU) is a potentially crippling consequence of diabetic foot disease. Aim of this study was to determine the risk of non-healing in ischemic as compared to neuropathic diabetic foot ulcers in relation to its grade and stage of infection. Methods: This prospective non-interventional study was conducted from July 2019 to February 2020 in Diabetes Management Center, Services Hospital Lahore Pakistan. Patients presenting with DFU were assessed for neurological and vascular status in the lower limbs. Ulcer grading was determined by Wagner's and Texas classification. Patients were followed up to 2-6 months for healing status of the diabetic foot ulcer.Results: Of 132 patients, 97 (73%) patients presented with neuropathic ulcer and 35 (27%) were having ischemic ulcers. Most participants were aged between 40-59 years. Based on Wagner's ulcer classification, it was observed that patient with score 2 had three times more likely to have their ulcer healed compared to those with score 1 and 3 [OR =3.09(95% CI:0.62-15.38, P=0.17)]. Kaplan-Meier survival curves showed that healing pattern among ischemic ulcer is considerably better compared to neuropathic foot ulcers. The evidence of equal survival hypothesis using Log-rank (Mantel Cox) test was statistically significant (p&lt;0.001). No statistically significant difference in healing pattern through time was found across Wagner's scoring categories.Conclusion: Peripheral neuropathy was the commonest pathology underlying DFU presenting at our tertiary level diabetes clinic. Early detection of neuropathy and timely foot care may help prevent ulceration with its often-grave consequences.

METABOLIC (TCPO2) AND HEMODYNAMIC DISCORDANCE IN PERIPHERAL VASCULAR EVALUATION OF POSTOPERATIVE STUMP NECROSIS. ABOUT TWO CASES AND LITERATURE REVIEW

Objective: Amputation levels are discussed based on hemodynamic approach. Transcutaneous oximetry (TcPO2) is a metabolic test of the local perfusion of peripheral tissues. we report two cases of discordance between hemodynamic and metabolic tests in the evaluation of the level of amputation on stump necrosis. Design and method: study of two cases of amputation level decision using ABI, arterial doppler ultrasound and TcPO2 Results: 1st case: patient A D 52 years old, type 2 diabetic for 11 years, admitted 12 days after amputation of the left forefoot following a complication of the infectious and neuropathic diabetic foot. The clinical examination found an infected necrosis of the amputation stump, the ABI is at 1.22. The arterial Doppler ultrasound objective an atheromatous overload and a good arterial flow. The TcPO2 is 69 mmHg next to the stump, contrasting with a TcPO2 of 27 mmHg on the right. The decision was a necrectomy associated with an antibiotic therapy adapted to the antibiogram. The evolution was favorable. 2nd case: patient S B 71 years old, hypertensive for 20 years, paraplegic for 20 years following a spinal trauma. Hospitalized for management of acute ischemia of the lower limbs on paroxysmal AF. Doppler ultrasound performed in the context of the emergency was in favor of the total occlusion of the regular poplar and leg arteries. Rejected from revascularization, evolution under anticoagulant was marked by the appearance of dry gangrene of both feet. The preoperative evaluation was in favor of a TcPO2 of 41 mmHg on the left and 75 mmHg on the right. An amputation of the two forefeet was performed. The postoperative evolution was characterized by a necrosis of the left stump requiring a complementary gesture with good consequences. Conclusions: The two cases clearly demonstrate the discrepancy between the classic evaluation (anatomical and hemodynamic) and the metabolic evaluation (TcPO2) The TcPO2 provides valuable assistance in deciding the level of amputation regardless of the diabetic, hypertensive, elderly patient profile….and regardless of the vascular profile; normal, PAD, post acute ischemia The TcPO2 is essential before each amputation procedure independently of the hemodynamic evaluation.

Sex-Related Differences and Factors Associated with Peri-Procedural and 1 Year Mortality in Chronic Limb-Threatening Ischemia Patients from the CLIMATE Italian Registry.

Identifying sex-related differences/variables associated with 30 day/1 year mortality in patients with chronic limb-threatening ischemia (CLTI). Multicenter/retrospective/observational study. A database was sent to all the Italian vascular surgeries to collect all the patients operated on for CLTI in 2019. Acute lower-limb ischemia and neuropathic-diabetic foot are not included. One year. Data on demographics/comorbidities, treatments/outcomes, and 30 day/1 year mortality were investigated. Information on 2399 cases (69.8% men) from 36/143 (25.2%) centers. Median (IQR) age: 73 (66-80) and 79 (71-85) years for men/women, respectively (p < 0.0001). Women were more likely to be over 75 (63.2% vs. 40.1%, p = 0.0001). More men smokers (73.7% vs. 42.2%, p < 0.0001), are on hemodialysis (10.1% vs. 6.7%, p = 0.006), affected by diabetes (61.9% vs. 52.8%, p < 0.0001), dyslipidemia (69.3% vs. 61.3%, p < 0.0001), hypertension (91.8% vs. 88.5%, p = 0.011), coronaropathy (43.9% vs. 29.4%, p < 0.0001), bronchopneumopathy (37.1% vs. 25.6%, p < 0.0001), underwent more open/hybrid surgeries (37.9% vs. 28.8%, p < 0.0001), and minor amputations (22% vs. 13.7%, p < 0.0001). More women underwent endovascular revascularizations (61.6% vs. 55.2%, p = 0.004), major amputations (9.6% vs. 6.9%, p = 0.024), and obtained limb-salvage if with limited gangrene (50.8% vs. 44.9%, p = 0.017). Age > 75 (HR = 3.63, p = 0.003) is associated with 30 day mortality. Age > 75 (HR = 2.14, p < 0.0001), nephropathy (HR = 1.54, p < 0.0001), coronaropathy (HR = 1.26, p = 0.036), and infection/necrosis of the foot (dry, HR = 1.42, p = 0.040; wet, HR = 2.04, p < 0.0001) are associated with 1 year mortality. No sex-linked difference in mortality statistics. Women exhibit fewer comorbidities but are struck by CLTI when over 75, a factor associated with short- and mid-term mortality, explaining why mortality does not statistically differ between the sexes.

The Effect of Vibration on the Acceleration of Wound Healing of Diabetic Neuropathic Foot Ulcer: A Prospective Experimental Study on Human Patients.

Diabetic foot ulcers are a common complication that occurs in approximately 15 percent of patients with diabetes mellitus. Over 60% of diabetic foot ulcers are caused by underlying neuropathy. Former studies on diabetic animals with foot wounds found that vibration platforms significantly accelerate wound healing by catalyzing epithelization, promoting angiogenesis, and enhancing muscle bulk. This result suggests that there is evidence that vibrations may accelerate diabetic neuropathic ulcer healing in human patients. However, to the best of our knowledge, the effect of vibration on the enhancements of diabetic foot ulcer healing in human patients is rarely investigated. Hence, in this work, we conducted an experimental study with human subjects to investigate whether vibration therapy, as a complement to the standard wound treatment, can accelerate the wound healing rate of diabetic neuropathic foot ulcers. In this prospective experimental study, 80 participants diagnosed with Wagner grades I−III diabetic neuropathic foot ulcers were randomly distributed to experimental (n = 40) and control groups (n = 40). Patients in the intervention group received standard wound treatment and vibration wound therapy (VWT), whereas patients in the control group retrieved only standard wound treatment. The results (p = 0.024, α = 0.05) show notable differences in the median healing rate between the intervention group (25 days, 95% CI: 20.3−29.7) and control group (33 days, 95% CI: 25.6−40.4), with the effect-size r, Cohen’s d, Glass’s Δ, and Hedges’ g, respectively, being 0.810, 2.764, 2.311, and 2.772. Moreover, the nitric oxide (NO) level, wound closure area, and wound healing score after intervention significantly differed between the two groups (p < 0.05), putting the intervention group on a higher level than the control group. Furthermore, positive associations were found between the NO level and wound healing closure rates. These findings suggested that VWT enhances diabetic neuropathic foot ulcer healing in terms of healing rate, wound closure area, healing score, and elevated NO level. Considering that no clinically adverse effects were found in the patients induced with vibration intervention, VWT can be regarded as a complementary therapy to the existing ones to accelerate the healing of DFUs.

The Effect of Customized Insole Pads on Plantar Pressure Distribution in a Diabetic Foot with Neuropathy: Material and Design Study Using Finite Element Analysis Approach

To reduce the trial and error in a real clinical scenario, the finite element analysis (FEA) can be effectively used to simulate various effective pad designs and a material selection to reduce and redistribute peak plantar pressure in a diabetic foot with neuropathy. The aim of this study was to investigate the effect of pad design and material stiffness on the reduction in plantar pressure in a diabetic foot with neuropathy using FEA. Three-dimensional foot models with a customized insole (CMI) were created to study the peak contact pressure. Ethylene vinyl acetate, Nora® Lunalastike, and thermoplastic polyurethane were assigned to the top, middle, and base layers of the CMI, respectively. Two types of pads were proposed: a heel pad and a heel–forefoot pad. Four different materials with different stiffnesses were assigned as pad materials including a void pad. The FEA revealed that pads with soft materials reduced peak plantar pressure more effectively than stiffer pads. The use of a softer heel–forefoot pad reduced the peak plantar pressure at the midfoot and forefoot compared with other pads. The findings suggest that the material and design selection for the fabrication of CMIs with pads are important factors in reducing plantar pressure and may be useful in the management of a neuropathic diabetic foot.

Re-Epithelialization of Neuropathic Diabetic Foot Wounds with the Use of Cryopreserved Allografts of Human Epidermal Keratinocyte Cultures (Epifast).

The application of tissue-engineering technology to wound healing has become an option for the treatment of diabetic foot ulcers (DFU). A comparative, prospective study was conducted to assess the efficacy of a cryopreserved allograft of human epidermal keratinocytes (Epifast) to enhance wound healing in granulating DFU. Eighty patients were assigned to receive Epifast (n = 40) or Standard Care (SC) treatment (n = 40). The Epifast group displayed a shorter duration of the epithelialization phase (3.5 ± 4 vs. 6.4 ± 3.6 weeks, p &lt; 0.05) and upon the entire wound healing process than the SC group (10 ± 5.7 vs. 14.5 ± 8.9 weeks, p &lt; 0.05), reaching wound closure at 16 and 30 weeks, respectively. The Kaplan-Meier analysis revealed that Epifast group patients were 50% more likely than the SC to heal wounds faster (Cox-hazards ratio of 0.5, 95% CI = 0.3-0.8, p &lt; 0.0001; Likelihood Ratio of 7.8. p &lt; 0.05). Patients in the control group displayed a slower healing as the Saint Elian (SEWSS) severity grade increased (group differences of 0.6, 3.8, and 4.3 weeks for grades I, II, and III, respectively). DFW treated with Epifast displayed a shorter time to complete re-epithelialization than wounds treated with standard care.

A Pilot Study Comparing a Micronized Adipose Tissue Niche versus Standard Wound Care for Treatment of Neuropathic Diabetic Foot Ulcers.

Numerous studies have demonstrated the various properties of micronized adipose tissue (MAT), including angiogenic, anti-inflammatory, and regenerative activities, which can be helpful in wound healing. This exploratory clinical trial aimed to report the efficacy and safety of MAT niche for treating diabetic foot ulcers. Twenty subjects were randomly divided into MAT niche treatment (n = 10) and control groups (n = 10). All patients were followed up weekly for 16 weeks. We evaluated the efficacy of the MAT niche treatment by assessing the (1) reduction in wound area after 4 weeks and (2) percentage of patients who achieved complete wound closure after 16 weeks. All possible adverse events were recorded. The wound area was reduced by 4.3 ± 1.0 cm2 in the treatment group and by 2.0 ± 1.1 cm2 in the control group (p = 0.043). Complete wound healing was achieved after 16 weeks in eight out of 10 patients (80%) in the treatment group and three out of six (50%) in the control group (p = 0.299). No serious adverse events related to MAT niche treatment were observed. Although the present study’s findings do not support the use of this therapy to treat foot ulcers of patients with diabetes owing to the small number of patients included and the absence of statistical significance, the results of this pilot preliminary study are promising in that MAT niche autografts may offer the possibility of a simple and effective treatment for diabetic ulcers. Further follow-up studies with a larger number of patients are required to validate our findings.

Psychological Aspects of Patients with Diabetic Neuropathic Foot

Psychological Aspects of Patients with Diabetic Neuropathic Foot

The Outcome of Surgical Treatment for the Neuropathic Diabetic Foot Lesions-A Single-Center Study.

The prevalence of diabetic foot complications is continuously increasing as diabetes has become one of the most important “epidemics” of our time. The main objective of this study was to describe the appropriate surgical intervention for the complicated neuropathic diabetic foot; the secondary goal was to find the risk factors associated with minor/major amputation and good or adverse surgical outcomes. This is an observational, retrospective study conducted between 1 January 2018 and 31 December 2019, which included 251 patients from the General Surgery Department at the Dr I. Cantacuzino Clinical Hospital in Bucharest with type II diabetes mellitus and neuropathic diabetic foot complications. The surgical conditions identified at admission were the following: osteitis (38.6%), infected foot ulcer (27.5%), gangrene (20.7%), infected Charcot foot (3.6%), non-healing wound (3.6%), necrosis (3.2%), and granulated wound (2.8%). We found that a minor surgical procedure (transmetatarsal amputation of the toe and debridement) was performed in 85.8% of cases, and only 14.2% needed major amputations. Osteitis was mainly associated with minor surgery (p = 0.001), while the gangrene and the infected Charcot foot were predictable for major amputation, with OR = 2.230, 95% CI (1.024–4.857) and OR = 5.316, 95% CI (1.354–20.877), respectively. Admission anemia and diabetic nephropathy were predictive of a major therapeutical approach, with p = 0.011, OR = 2.975, 95% CI (1.244–8.116) and p = 0.001, OR = 3.565, 95% CI (1.623–7.832), respectively. All the major amputations had a good outcome, while only several minor surgeries were interpreted as the adverse outcome (n = 24). Osteitis (45.8%) and admission anemia (79.2%) were more frequently associated with adverse outcomes, with p = 0.447 and p = 0.054, respectively. The complicated neuropathic diabetic foot requires a surgical procedure mainly associated with a good outcome.

A Feasibility and Safety Study of a Novel Human Decellularized Dermal Matrix to Accelerate Healing of Neuropathic Diabetic Foot Ulcers in People With Type 1 and Type 2 Diabetes

ObjectivesThe purpose of this study was to determine the feasibility and safety of a novel decellularized dermal matrix (DDM) for the treatment of chronic diabetic foot ulcers (DFUs). MethodsAn interventional, single-arm, prospective study of DDM for DFU treatment was conducted in 2 Canadian centres from July 1, 2016, to May 30, 2017. Individuals ≥18 years of age with an active DFU of ≥2 weeks and ulcer area ≥1 cm2 before debridement and who consented to participate were enrolled in this clinical trial. ResultsA total of 11 patients were enrolled, with 9 patients (82%) having achieved 100% closure between 2 and 8 weeks. The mean and median times to wound closure for these patients were 3.3 and 2.5 weeks, respectively. The mean and median reductions in wound area at 4 weeks posttreatment were 87% and 100%, respectively. The proportion of patients having achieved complete healing at 12 weeks was 82%. All patients received only 1 DDM application to achieve these results. There were no adverse events related to use of the product. No cases of recurrence during a 1-year follow-up after completion of the study were reported for patients who achieved wound closure. ConclusionsThese findings provide evidence that this DDM may be safe and effective for the treatment of chronic, hard-to-heal neuropathic DFUs. Specifically, DDM demonstrated the potential to accelerate healing of DFUs when compared with reported times of 8 to 12 weeks required to achieve closure using the current standard of care.

Efficacy and Safety of Topical Solution of Diperoxochloric Acid for Neuropathic Diabetic Foot Ulcer: Results from a Phase 3, Multicentre, Randomized, Active-controlled, Parallel-group Study.

Diabetic foot ulcer (DFU), if untreated, accounts for lower-limb amputations affecting patients' quality-of-life. Diperoxochloric acid (DPOCL) is known to heal DFU by its antibacterial and fibroblast stimulating activity. This was a phase 3, multicentre, randomized, double-blind, active-controlled, parallel-group study conducted to evaluate the efficacy and safety of topic solution of DPOCL compared with isotonic sodium chloride solution (ISCL). Adult patients with type 1 or 2 diabetes with random blood glucose levels of <250 mg/dL, with ≤ than three full-thickness foot ulcers were enrolled. Primary efficacy endpoint was complete wound closure and secondary was wound surface area. Adverse events were analyzed as safety endpoint. Of 311 enrolled patients, 289 were randomized 1:1 to DPOCL (139) and ISCL (150) treatment (10-weeks [8-Visits]). Percentage of patients with complete wound closure at visit-8, were significantly higher (P = .0156) in DPOCL arm (76% [105/139]) compared to ISCL (62% [93/150]) arm. At end-of-study, mean wound surface area in DPOCL arm (0.639 cm2) was significantly lower (P = .0209) compared to ISCL (0.818 cm2) arm. One death was reported in control arm which was not considered as treatment-related. No important safety finding were observed. Results indicate that, DPOCL can be considered as effective and safe treatment option for DFU compared to ISCL, although future confirmatory studies are warranted.

Pie diabetico y estilo de vida: Reporte de Caso

Diabetes is still the leading cause of non-traumatic amputation in most Western countries, epidemiological reports indicate that more than a million amputations are performed in people with diabetes each year, this is equivalent to an amputation for diabetes somewhere in the world every 30 seconds, most of these amputations are preceded by ulcers. We present a case of a 39-year-old male patient suffering from diabetes mellitus and uncontrolled hypertension, with late complications, chronic kidney disease, anemia, retinopathy, and ischemic and neuropathic diabetic foot, with indication for amputation. Healthy lifestyles are used, controlling glycemia, hypertension, without requiring medication and reducing proteinuria. There were no adverse effects. With favorable evolution since then. Conclution: A healthy lifestyle is an intervention that the earlier it is used, the greater its benefits, without the risk of adverse effects or unnecessary costs, but even in late stages it has shown benefits in glycemic, hypertensive and renal control.