History Of Diabetic Foot Ulcer Research Articles

Psychological factors and diabetic foot ulceration: a scoping review of the bi-directional relationship between diabetic foot ulcer healing and mental health factors

Introduction Diabetic foot ulceration (DFU) is a major complication of diabetes and is associated with high morbidity and mortality rates. Psychological factors are believed to play a role in wound healing, but it remains uncertain if psychological interventions can help individuals with an active DFU, or a history of DFUs, to achieve complete or improved wound healing or prevent recurrence. Objective The objective of the proposed scoping review is to investigate the emotional consequences/burden of living with DFU and to examine how psychosocial factors may impact progression and management of ulcerations. Methods This review will be conducted in accordance with the Joanna Briggs Institute methodology for scoping reviews and the Preferred Reporting Items for Systematic reviews and Meta-Analysis extension for Scoping Reviews (PRISMA-ScR) will guide the reporting of results. Discussion While factors such as stress, depression, social support, and adherence to treatment have been identified as variables that may negatively affect DFU healing, there is a need for a greater understanding of how psychological and behavioural variables such as these may influence ulcer incidence, healing and recurrence in people with diabetes. This review will comprise of a broad and systematically mapped synthesis of the identified data. Findings will be used to provide a better understanding of the bi-directional relationship between DFU and psychological variables and will provide direction for the development or adaptation of a tailored psychological intervention that will aim to optimise wellbeing and improve outcomes for individuals with DFU.

Psychological factors and diabetic foot ulceration: a scoping review of the bi-directional relationship between diabetic foot ulcer healing and mental health factors

Introduction Diabetic foot ulceration (DFU) is a major complication of diabetes and is associated with high morbidity and mortality rates. Psychological factors are believed to play a role in wound healing, but it remains uncertain if psychological interventions can help individuals with an active DFU, or a history of DFUs, to achieve complete or improved wound healing or prevent recurrence. Objective The objective of the proposed scoping review is to investigate the emotional consequences/burden of living with DFU and to examine how psychosocial factors may impact progression and management of ulcerations. Methods This review will be conducted in accordance with the Joanna Briggs Institute methodology for scoping reviews and the Preferred Reporting Items for Systematic reviews and Meta-Analysis extension for Scoping Reviews (PRISMA-ScR) will guide the reporting of results. Discussion While factors such as stress, depression, social support, and adherence to treatment have been identified as variables that may negatively affect DFU healing, there is a need for a greater understanding of how psychological and behavioural variables such as these may influence ulcer incidence, healing and recurrence in people with diabetes. This review will comprise of a broad and systematically mapped synthesis of the identified data. Findings will be used to provide a better understanding of the bi-directional relationship between DFU and psychological variables and will provide direction for the development or adaptation of a tailored psychological intervention that will aim to optimise wellbeing and improve outcomes for individuals with DFU.

Podiatrist intervention could reduce the incidence of foot ulcers in patients with diabetes: a hospital survey in China.

This study aimed to evaluate the effectiveness of podiatrists in preventing diabetic foot ulcers (DFUs) in China. The study was a prospective investigation. A total of 300 patients were enrolled from May 2016 to May 2018 in Handan Central Hospital, China. All patients who participated in this study had been diagnosed with type 2 diabetes, according to the International Classification of Diseases (ICD-10). All participants underwent our survey, which included basic patient data and information about DFUs. The patients were followed for one year, during which time they received appropriate intervention from podiatrists, including lifestyle guidance, callus resection, tinea grinding and ingrown nail correction. At the end of the year all the patients were surveyed again. The data before and after the year were statistically compared. The results showed that the incidence of DFUs in patients with diabetes was significantly decreased after one year of intervention from podiatrists (20.7% versus 6.7%, p<0.001). Additionally, there was a negative correlation between the number of intervention visits and the number of DFU occurrences (Spearman correlation coefficient: -0.496, p<0.001). Furthermore, we found that 68 patients with a history of DFUs or amputation had an obviously reduced incidence of DFUs after intervention by a podiatrist (89.7% versus 27.9%, p<0.001). We also investigated other foot risk factors in all participants, such as limb neuropathy (76.3%), lower extremity vascular disease (65.7%) and foot paralysis (43.7%). The results of this study help in understanding the situation of patients with diabetes in China and to prove that standardised podiatrist intervention has an important role in inhibiting the occurrence and development of DFUs.

History of Diabetic Foot Ulcer is Associated With Increased Risk of Prosthetic Joint Infection and Sepsis After Total Joint Arthroplasty

BackgroundDiabetic foot ulcers (DFUs) are common sequelae of diabetes mellitus. Currently, the effect of DFUs on total joint arthroplasty (TJA) outcomes is sparsely evaluated. This study investigated whether DFU patients undergoing TJA increases risk of (1) prosthetic joint infections (PJI), (2) surgical site infections (SSI), (3) sepsis, (4) readmissions, and (5) revisions. MethodsUsing PearlDiver, a retrospective query from January 1, 2010 to October 31, 2020 was performed. DFU patients undergoing total knee arthroplasty (TKA) and total hip arthroplasty (THA) were included and 1:5 propensity score matched with controls using age, sex, body mass index, and various comorbidities (33,155 TKA patients [DFU = 5,529; control = 27,626]; 17,146 THA patients [DFU = 2,862; control = 14,284]). Outcomes included rates of PJI, SSI, sepsis, readmissions, and revisions. Multivariate logistical regressions calculated odds ratios (ORs), 95% confidence intervals, and P values (P < .001 as significance threshold). ResultsDFU increased risk of sepsis within 90 days of TKA (OR 4.59; P < .001) and THA (OR 4.87; P < .001). DFU did not increase risk of PJI at 90 days for TKA (OR 0.8; P = .1) or THA (OR 0.85; P = .34) but did by 2 years post-TKA (OR 1.51; P < .001) and THA (OR 1.55; P < .001). Risk of SSI increased in DFU cohort following TKA and THA at 90 days and 2 years and at 90-day readmissions and 2-year revisions. ConclusionDFU patients undergoing TJA demonstrated increased risk of postoperative sepsis and PJI. Furthermore, DFU patients demonstrated an increased risk of SSI, readmissions, and revisions. Providers should counsel DFU patients about postoperative risks.

Prescribing Home Digital Thermometry Coupled with Activity Dosing and Optimized Offloading to Prolong Diabetic Foot Remission: A Case Report.

People with a history of diabetic foot ulcers (DFUs) experience diminished health-related quality of life and are at a 40% annual risk of DFU recurrence. Due to a fear of DFU recurrence, people in DFU remission participate less in physical activity and moderate-intensity exercise when compared to people with diabetes who have not had wounds. There is novel evidence to suggest that too little activity during DFU remission contributes to only low magnitudes of repetitive tissue loading creating a higher susceptibility to skin trauma during inadvertent high-activity bouts. Conversely, a hasty return to too much activity could lead to rapid recurrence. There is now high-level evidence from multiple meta-analyses to indicate that home-based foot temperature monitoring, coupled with activity modification and daily inspection of the feet for impending signs of ulceration, could reduce the risk of ulcer recurrence by 50%. There is little evidence, however, to guide the decision-making regarding the appropriate quantity and frequency of physical activity during DFU remission and the acceptability from the patient perspective. This has resulted in limited uptake of this novel intervention in clinical practice. Earlier, we proposed that activity can be dosed for people in foot ulcer remission, just like insulin or medication is dosed. Here, we describe a patient-centered approach to implementing home foot temperature monitoring coupled with daily foot checks and dosage-based return to physical activity in a patient in DFU remission, including his perspective. We believe using such an approach could maximize ulcer-free days in remission, thereby improving quality of life.

Screening for the loss of protective sensation in people without a history of diabetic foot ulceration: Validation of two simple tests in India

The ability of the Ipswich touch test (IpTT) and VibratipTM to detect loss of protective sensation (LOPS) was tested against a neurothesiometer in an outpatient diabetic population without a history for ulceration. Our results support the use of the IpTT as a screening tool for LOPS, but not of VibratipTM.

Evaluation of the Effectiveness of Remote Foot Temperature Monitoring for Prevention of Amputation in a Large Integrated Health Care System

OBJECTIVEWe evaluated the effectiveness of remote foot temperature monitoring (RTM) in the Veterans Affairs health care system.RESEARCH DESIGN AND METHODSWe conducted a retrospective cohort study that included 924 eligible patients enrolled in RTM between 2019 and 2021 who were matched up to 3:1 to 2,757 nonenrolled comparison patients. We used conditional Cox regression to estimate adjusted cause-specific hazard ratios (aHRs) and corresponding 95% CIs for lower-extremity amputation (LEA) as the primary outcome and all-cause hospitalization and death as secondary outcomes.RESULTSRTM was not associated with LEA incidence (aHR 0.92, 95% CI 0.62–1.37) or all-cause hospitalization (aHR 0.97, 95% CI 0.82–1.14) but was inversely associated (reduced risk) with death (aHR 0.63, 95% CI 0.49–0.82).CONCLUSIONSThis study does not provide support that RTM reduces the risk of LEA or all-cause hospitalization in individuals with a history of diabetic foot ulcer. Randomized controlled trials can overcome important limitations.

A vicious cycle: employment challenges associated with diabetes foot ulcers in an economically marginalized Southwest US sample.

To describe patients' reported employment challenges associated with diabetic foot ulcers (DFUs). Fifteen patients from under-resourced communities in Southern Arizona, with a history of DFUs and/or amputations, were recruited from a tertiary referral center from June 2020 to February 2021. Participants consented to an audio-recorded semi-structured phone interview. Interviews were transcribed and thematically analyzed using the Dedoose data analysis platform. Participants shared a common theme around the cyclic challenges of DFU prevention/management and employment. Those employed in manual labor-intensive jobs or jobs requiring them to be on their feet for long durations of time believed working conditions contributed to the development of their DFUs. Patients reported work incapacity due to declines in mobility and the need to offload for DFU management. Many expressed frustration and emotional distress related to these challenges noting that DFUs resulted in lower remuneration as medical expenses increased. Consequently, loss of income and/or medical insurance often hindered participants' ability to manage DFUs and subsequent complications. These data illuminate the vicious cycle of DFU and employment challenges that must be addressed through patient-centered prevention strategies. Healthcare providers should consider a person's contextual factors such as employment type to tailor treatment approaches. Employers should establish inclusive policies that support patients with DFUs returning to work through flexible working hours and adapted work tasks as needed. Policymakers can also mitigate employment challenges by implementing social programs that provide resources for employees who are unable to return to work in their former capacity.

Thoughts and experiences regarding leg amputation among patients with diabetic foot ulcers: A phenomenological study.

Despite lower-limb amputation being common among patients with diabetic foot ulcers, few studies have qualitatively investigated the patients' perspectives. Therefore, this study aimed to explore the thoughts and experiences of patients with diabetic foot ulcers regarding lower-limb amputation in Hong Kong. A phenomenological study using individual, semi-structured interviews was conducted with 18 participants with foot ulcers recruited in Hong Kong between July and September 2022. The interviews were audio-recorded, transcribed verbatim, and analysed using an interpretative phenomenological approach and a constant comparison strategy. The results highlighted four substantial themes: (a) coping or being alone and taciturn, (b) altered appearance impacting one's sense of maintaining social relations, (c) thoughts about self-efficacy and encountering a new normal, and (d) the possibility of a reduced gap in physical consequences between the old and new self. This study provided different perspectives of patients with a history of diabetic foot ulcers, even in cases where lower-limb amputation has not yet been performed. The results demonstrate that lower-limb amputation is considered a forbidden topic. This makes it culturally difficult for Chinese patients to discuss the matter with healthcare authorities and family members. Healthcare workers should be aware of how they communicate regarding lower-limb amputation.

The High Re-Ulceration Rate in Lower Extremity Amputation Intervention in Type 2 Diabetic Vietnamese Patients After 24-Month Follow-Up at Cho Ray Hospital, Vietnam.

Diabetic foot ulcers (DFU) are a prevalent and severe disease with vascular and/or neurological complications, and if not diagnosed and treated promptly, it may rapidly deteriorate. Despite amputation or nonamputation treatment, there is still a high rate of re-ulceration. Previous studies have shown that the recurrence rate varies from 43% to 59% after 2 years. Currently, there is still a high rate of lower extremity amputation intervention, particularly above-the-ankle amputation, at Cho Ray Hospital in Vietnam, reaching 50%. The effectiveness of this intervention in the long term based on re-ulceration has not been evaluated in Vietnamese diabetic patients (DPs). This study aims to describe the long-term outcomes of amputation intervention in Type 2 DPs after 24 months and identify factors related to DFU recurrence in order to improve DFU management in low-middle-income countries like Vietnam. From January to June 2022, archived clinical and direct visit or phone follow-up data were collected and analyzed from diabetic foot ulcer patients with low extremity amputation who were treated at Cho Ray hospital from 2018 to 2020. The high re-ulceration rate in the 24th month was 29.8% (17/57), and the factor related to this outcome was "late diagnosis and care" (32.4 days vs 26.9 days with P = .03). Other potential factors (higher rates but no significant statistical difference with P > .05) included failure of HbA1c control greater than 9% (82.5% vs 67.5%), the severity of foot ulcers with TEXAS 3B (82% vs 60%), the number of years having diabetes (8.7 years vs 6.7 years), loss of monofilament sensation (82.5% vs 70.6%), and a history of diabetic foot ulcer (17.6% vs 10%). The re-ulceration after 24 months might depend on various clinical factors. Therefore, early diagnosis and care for diabetic foot ulcers could help reduce amputation rates and the risk of re-ulceration.

A Retrospective Cohort Study on Diabetic Foot Disease: Ascertainment of Ulcer Locations by Age Group.

Background and aimsDiabetic foot ulcer location is a known independent predictor for cure with a better healing gradient proximal to distal. Although advanced age is one of the main factors associated with greater diabetic foot ulcer severity, there are no studies evaluating diabetic foot ulcer location specifically in the elderly population in an outpatient setting. This study evaluated diabetic foot ulcer location and age-group interactions in diabetic foot presentation.MethodsA retrospective cohort study including adult patients with diabetic foot ulcers observed on their first visit to our center's Diabetic Foot Unit in 2018, divided into younger adults (YA) (18 to 64 years) and older adults (OA) (≥65 years).ResultsA total of 435 patients were included in the study with 159 (36.6%) in the YA, and 276 (63.4%) in the OA group.Neuro-ischemic diabetic foot ulcers were more frequent in the OA group (71.4% vs 43.4%, p<0.001). The number of patients with a history of diabetic foot ulcers was lower in the OA group (18.1% vs 25.2%, p=0.03). A smaller proportion of forefoot diabetic foot ulcers (74.9% vs 86.2%, p=0.007) and plantar location diabetic foot ulcers (9.4% vs 24.5%, p<0.001) occurred in the OA group.By univariate logistic regression analysis, we found two associations with older age: proximal (odds ratio (OR) 2.09 (1.23-3.53), p=0.006), and non-plantar (OR 3.13 (1.82-5.37), p<0.001) diabetic foot ulcer location. After adjusting for potential confounders in a multivariate analysis, older age lost the association to more proximal (OR 1.72 (0.94-3.15), p=0.081) and non-plantar (OR 1.78 (0.83-3.77), p=0.133) diabetic foot ulcer location.ConclusionsThere are essential age differences in diabetic foot ulcer presentation. The OA group more frequently presents neuro-ischemic diabetic foot ulcers with more proximal and non-plantar locations.

Evaluation of foot ulcer incidence in diabetic patients at a diabetic foot ulcer prevention clinic over a 10-year period.

The present study aimed to evaluate diabetes patients over a 10-year period that visited our outpatient clinic for prevention of diabetic foot ulcers and then investigate the incidence and aetiology of diabetic foot ulcers. The Department of Diabetes and Metabolic Diseases of a university hospital was in charge of the clinic that provided diabetes patients with individual education via the use of visualisation techniques. In this prospective cohort study, a total of 942 diabetes patients who visited the clinic were evaluated for neuropathy, angiopathy and medical history between November 2006 and March 2017. Using the patients' medical records, diabetic foot ulcer development was evaluated between the day of the first visit and December 31, 2018, with 20 out of 942 participants developing these ulcers. Over a period of 12, 60 and 120 months, the diabetic foot ulcer cumulative incidence was 0.2%, 2.4% and 5.8%, respectively. A history of diabetic foot ulcers and the male sex were shown by a Cox regression analysis to be correlated with diabetic foot ulcer development (Hazard Ratio [HR] 11.55, 95%CI 4.600-29.004, p < 0.001; and HR 3.55, 95%CI 1.031-12.196, p=0.045, respectively). However, only five out of 20 participants with ulceration returned to the clinic for re-examination. In conclusion, a 12-month evaluation showed there was a low incidence of diabetic foot ulcers. These results might suggest that patients with a diabetic foot ulcer history need to undergo at least an annual follow-up in order to further reduce diabetic foot ulcer incidence, although studies involving control groups needs to be conducted, in presenting these as evidence.

Psychometric properties of the Indonesia version religious health fatalism questionnaire in diabetic foot ulcer outpatients.

Background:Religious health fatalism belief that health outcome is only determined by God without seeking treatment. Tools are needed to measure fatalism among patients with chronic disease, especially diabetic foot ulcer (DFU) patients. The aim of this study was to conduct psychometric test of religious health fatalism questionnaire (RHFQ) including translation, validation, reliability, and cut-off point among DFU out-patients.Design and methods:This study employed cross sectional design, using self-report questionnaire. Data were collected from diabetes clinic in five hospitals, Indonesia. The inclusion criteria were patients who had history of DFU more than 2 years. Total sample in this study was 184 patients. This study was conducted from April to June 2021. Permission to use the RHFQ was permitted by the original author. We conducted translation and adaptation questionnaire to Bahasa. We employed reliability test with internal consistency, construct validity, and convergent validity. Construct validity was evaluated using exploratory factor analysis (EFA). Cut-off point RHS was analyzed using receiver operating characteristic (ROC). ROC was evaluated using correlation score between total score RHFQ and CDRISC-25 Indonesia version. Previous study mentioned that resilience is a predictor of religious. The Cronbach’s alpha for RHFQ Indonesia version was adequate.Results:EFA showed adequate with Kaiser–Meyer-Olkin (KMO) value of 0.72 and the Bartlett’s test of sphericity was significant. According to ROC curve analysis, the cut-off point at a score 67.5 indicated the best sensitivity and specificity.Conclusions:RHFQ Indonesia version had reliability and validity for screening religious health fatalism among DFU outpatients.

Comparing the standard surgical dressing with dehydrated amnion and platelet-derived growth factor dressings in the healing rate of diabetic foot ulcer: A randomized clinical trial

AimsThe management of diabetic foot ulcers is a challenging issue due to the pathophysiological background, delay in healing, and prevalence of diabetes. The purpose of this study was to compare the therapeutic effects of the three methods of diabetic wound care: surgical debridement and dressing, dressing with dehydrated amnion powder, and dressing with platelet-derived growth factor gel. MethodsIn this multi-arm parallel-group randomized trial, 243 patients with a minimum 4-week medical history of diabetic foot ulcers with Wagner’s grades 1 and 2, no infection, and adequate tissue blood flow were randomly assigned to one of three 81-person groups: surgical debridement (the standard method), dehydrated amnion dressing, or platelet-derived growth factor dressing. The follow-up period lasted 12 weeks. The percentage area reduction (PAR) was measured as the final target. SPSS version 25 was used to perform statistical analysis on the data. ResultsAll three study groups were comparable in terms of the type of ulcer, the area of ulcer, Wagner’s grade, the period, and the ulcer’s size. The PAR in the surgical debridement, platelet-derived growth factor, and dehydrated amnion groups were 7.4%, 14.8%, and 49.3% in week 4; 20.1%, 35.8%, and 79% in week 6; 43.7%, 56.8%, 86.4% in week 8; and 50%, 61.7%, and 87.6% in weeks 10 and 12, respectively. The observed differences were statistically significant (p < 0.05) over the entire period. ConclusionThe study concluded that dehydrated amnion dressing, when compared to platelet-derived growth factor dressing and surgical debridement, resulted in better-improved healing in diabetic foot ulcer patients.

Is a Left-to-Right >2.2°C Difference a Valid Measurement to Predict Diabetic Foot Ulceration in People with Diabetes and a History of Diabetic Foot Ulceration?

Monitoring foot skin temperatures at home have been shown to be effective at preventing the occurrence of diabetic foot ulcers. In this study, the construct validity of using >2.2°C difference between contralateral areas on the foot as a warning sign of imminent ulceration is explored. Thirty participants with diabetes at high risk of ulceration (loss of protective sensation and previous ulceration and/or amputation) monitored their foot temperatures at six sites, four times a day for six days using a handheld infrared thermometer. Walking activity, time of day, and environmental temperature were also monitored and correlated with foot temperatures. We found that contralateral mean skin temperature difference was 0.78°C at baseline. At single sites, left-to-right temperature differences exceeding the threshold were found in 9.6% of measurements (n = 365), which reduced to 0.4% when individually corrected and confirmed the next day. No correlation was found between contralateral temperature differences and activity, time of day, and environmental temperature. We conclude that using a >2.2°C difference is invalid as a single measurement in people at high risk of ulceration, but the construct validity is appropriate if both individual corrections and next day confirmation are applied.

Is There an Association between Sleep Disorders and Diabetic Foot? A Scoping Review.

Diabetic foot is associated with a low quality of life since physical disabilities, mood disturbances and psychological disorders are frequent. One of the most important biological processes to ensure quality of life is sleep. Sleep disorders can impair glycemic control in patients with diabetes mellitus or even cause long-term type 2 diabetes mellitus. The aim of this study is to carry out a scoping review about the association between sleep cycle disorders and diabetic foot. PubMed, Scopus, CINAHL, PEDro, Cochrane Library, SCIELO and EMBASE databases were chosen for the search and the following terms were used: “diabetic foot”,“sleep*”,“rest-activity”,“mood” and“behavior”. All the studies should include outcome variables about sleep and diabetic foot. Finally, 12 articles were selected, all of whichwere observational. The most frequent variables were those regarding diabetic foot ulcer aspects and diabetic neuropathy on one side, and obstructive sleep apnea, sleep duration and sleep quality on the other side. The results suggest that there is a possible association between obstructive sleep apnea and the presence or history of diabetic foot ulcers. No direct associations between sleep quality or sleep duration and diabetic foot or diabetic foot ulcer variables have been found.

267-OR: Assessing Patient Knowledge about Diabetic Foot Ulcer Offloading

Introduction: Standard of care for diabetic foot ulcers (DFU) includes wound debridement, dressing changes, diabetes control, and offloading. Despite this, half of all patients fail to heal when standard of care is met. Offloading DFU is critical to promote wound healing, yet patient adherence is undesirably low and contributes to failed wound healing. We evaluated patient knowledge of DFU offloading through a voluntary telephone survey. Methods: Participants were recruited from a tertiary care center podiatry department and completed a 21-item telephone survey. All subjects had a history of diabetes and were included regardless of DFU history. Descriptive statistics and chi square were calculated to evaluate survey responses. Results: Currently 92 of 167 subjects (55.1%) completed the telephone survey. All subjects regardless of DFU history correctly identified DFU increases risk of amputation (DFU95.7%; n=88/92). All subjects regardless of DFU history identified “offloading” and “pressure relief” as important factors to improve DFU healing (97.8%; n=90/92; 98.9%; n=91/92, respectively). Only a minority (43.5%; n=40/92) of participants were able to correctly identify the best offloading strategy, regardless of DFU history (DFU history 48.5%; n=16/33 vs. No DFU history 40.7%; n=24/59; p=0.5155). Discussion: We hypothesized people with a history of a DFU would understand the concept of offloading better, but yet patients who had a history of a DFU were as likely to misunderstand the term “offloading” compared to patients who have no history of a previous DFU. Our findings importantly identify a gap in patient education surrounding an essential component of DFU standard of care. Disclosure R. A. Burmeister: None. C. Holmes: None. C. Jarocki: None. T. Strom: None. G. M. Torrence: Research Support; Self; Kent Imaging. B. M. Schmidt: None.

Effects of novel diabetic therapeutic footwear on preventing ulcer recurrence in patients with a history of diabetic foot ulceration: study protocol for an open-label, randomized, controlled trial

BackgroundRecurrence after the healing of a foot ulcer is very common among patients with diabetes mellitus. Novel diabetic therapeutic footwear consisted of merino wool, vibration chip, and orthopedic insoles is designed to influence multifaceted mechanisms of foot ulcer occurrence. The aim of this study is to examine the effect of the optimally designed therapeutic footwear on preventing ulcer recurrence in patients with a history of diabetic foot ulcers (DFU).Methods/designThe trial is designed as a two arms, parallel-group, open-label randomized controlled intervention study. The Log-rank Test was used for calculating sample size based on the latest national multicenter survey data of DFU in China. Three hundred and twenty participants will be recruited from the Diabetic Foot Care Center, West China Hospital, Sichuan University. Adults with diabetic peripheral neuropathy, healed foot ulceration in the 3 months prior to randomization, and aged ≥18 years, will be recruited. Participants will be randomized to receive novel diabetic therapeutic footwear (n = 160) or their own footwear (n = 160). The primary outcome will be the incidence of ulcer recurrence. The secondary outcome will be measurements of barefoot dynamic plantar pressures, the influence of footwear adherence on ulcer recurrence, and the incidence of cardiovascular events. Assessment visits and data collection will be obtained at baseline, 1, 3, 6, 9, and 12 months. The intention-to-treat principle will be applied. A cox regression model will be used to calculate the hazard ratio for the incidence of ulcer recurrence. The change of barefoot dynamic plantar pressures will be assessed using repeated measures ANOVA. The study protocol has been approved by the Ethics Committee of The Biomedical Research Ethics Committee of West China Hospital, Sichuan University (Reference No. 2019(96)).DiscussionThis clinical trial will give information on the ability of novel diabetic footwear on preventing ulcer recurrence in patients with a history of diabetic foot ulceration. If the optimally designed therapeutic footwear does work well, the findings will contribute to the development of innovative treatment devices for preventing foot ulcer recurrence in high-risk patients.Trial registrationChinese Clinical Trial Registry ChiCTR1900025538. Registered on 31 August 2019.

Psychological interventions for treating foot ulcers, and preventing their recurrence, in people with diabetes.

Diabetic foot ulceration (DFU) can be defined as a full-thickness wound below the ankle and is a major complication of diabetes mellitus. Despite best practice, many wounds fail to heal, and when they do, the risk of recurrence of DFU remains high. Beliefs about personal control, or influence, on ulceration are associated with better engagement with self-care in DFU. Psychological interventions aim to reduce levels of psychological distress and empower people to engage in self-care, and there is some evidence to suggest that they can impact positively on the rate of wound healing. To evaluate the effects of psychological interventions on healing and recurrence of DFU. In September 2019, we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE (including In-Process & Other Non-Indexed Citations), Ovid Embase, Ovid PsycINFO and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and reviewed reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting. We included randomised controlled trials (RCTs) and quasi-RCTs that evaluated psychological interventions compared with standard care, education or another psychological intervention. Our primary outcomes were the proportion of wounds completely healed; time to complete wound healing; time to recurrence and number of recurrences. Four review authors independently screened titles and abstracts of the studies identified by the search strategy for eligibility. Three authors independently screened all potentially relevant studies using the inclusion criteria and carried out data extraction, assessment of risk of bias and GRADE assessment of the certainty of the evidence. We identified seven trials that met the inclusion criteria with a total of 290 participants: six RCTs and one quasi-RCT. The studies were conducted in Australia, the USA, the UK, Indonesia, Norway and South Africa. Three trials used a counselling-style intervention and one assessed an intervention designed to enhance an understanding of well-being. One RCT used a biofeedback relaxation training intervention and one used a psychosocial intervention based on cognitive behavioural therapy. A quasi-RCT assessed motivation and tailored the intervention accordingly. Due to the heterogeneity of the trials identified, pooling of data was judged inappropriate, and we therefore present a narrative synthesis. Comparisons were (1) psychological intervention compared with standard care and (2) psychological intervention compared with another psychological intervention. We are uncertain whether there is a difference between psychological intervention and standard care for people with diabetic foot ulceration in the proportion of wounds completely healed (two trials, data not pooled, first trial RR 6.25, 95% CI 0.35 to 112.5; 16 participants, second trial RR 0.59, 95% CI 0.26 to 1.39; 60 participants), in foot ulcer recurrence after one year (two trials, data not pooled, first trial RR 0.67, 95% CI 0.32 to 1.41; 41 participants, second trial RR 0.63, 95% CI 0.05 to 7.90; 13 participants) or in health-related quality of life (one trial, MD 5.52, 95% CI -5.80 to 16.84; 56 participants). This is based on very low-certainty evidence which we downgraded for very serious study limitations, risk of bias and imprecision. We are uncertain whether there is a difference in the proportion of wounds completely healed in people with diabetic foot ulceration depending on whether they receive a psychological intervention compared with another psychological intervention (one trial, RR 2.33, 95% CI 0.92 to 5.93; 16 participants). This is based on very low-certainty evidence from one study which we downgraded for very serious study limitations, risk of bias and imprecision. Time to complete wound healing was reported in two studies but not in a way that was suitable for inclusion in this review. One trial reported self-efficacy and two trials reported quality of life, but only one reported quality of life in a manner that enabled us to extract data for this review. No studies explored the other primary outcome (time to recurrence) or secondary outcomes (amputations (major or distal) or cost). We are unable to determine whether psychological interventions are of any benefit to people with an active diabetic foot ulcer or a history of diabetic foot ulcers to achieve complete wound healing or prevent recurrence. This is because there are few trials of psychological interventions in this area. Of the trials we included, few measured all of our outcomes of interest and, where they did so, we judged the evidence, using GRADE criteria, to be of very low certainty.

Evaluation of type 1 diabetic patients: A single center experience

We evaluated patients diagnosed with type 1 DM who were followed at our clinic by conducting a retrospective chart review. Medical records of a total of 147 patients with type 1 DM (70 females, 77 males) with a mean (±SD) age of 31.2±9.7 years were reviewed retrospectively. The study patients had a mean duration of follow-up of 13.9±9.5 years, mean duration of follow-up of 4±2.6 years at our clinic and a mean HbA1c value of 8.3±2.1%. Microvascular complications were recorded in medical files for 128 patients. There were 48 (37.5%) patients with at least one microvascular complication. Medical records showed that out of 128 patients, 23 (18%) had diabetic neuropathy alone, 4(3%) had diabetic retinopathy alone and 5 (4%) had diabetic nephropathy alone. Ten patients (8%) had both diabetic nephropathy and diabetic retinopathy and 6 (4.7%) patients had all three microvascular complications. No significant difference was observed between patients with or without microvascular complications in terms of HbA1c (HbA1c 8.3% versus 8.1%; p=0.85). A history of diabetic foot ulcer was present in 4 patients in the study sample (4/147=2.7% of all patients).Twenty-two (15%) patients were on insulin pump therapy during follow-up. Insulin pump users had a significantly lower HbA1c value (7.9%) compared to those not using insulin pump (8.5%) (p=0.02). At our clinic, special efforts are being made to ensure type 1 diabetic individuals have regular outpatient examinations. Despite all these measures, our patients are still far from reaching their target HbA1c values, suggesting that we have to do much more help patients achieve their glycemic goals.