Psychological interventions for treating foot ulcers, and preventing their recurrence, in people with diabetes.
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ABSTRACT:
SUBMITTER: McGloin H
PROVIDER: S-EPMC8095008 | biostudies-literature | 2021 Feb
REPOSITORIES: biostudies-literature
Publications
Psychological interventions for treating foot ulcers, and preventing their recurrence, in people with diabetes.
McGloin Helen H Devane Declan D McIntosh Caroline D CD Winkley Kirsty K Gethin Georgina G
The Cochrane database of systematic reviews 20210208
<h4>Background</h4>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 ...[more]
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Project description:BackgroundIt has been reported that ozone therapy might be helpful in treating foot ulcers in people with diabetes mellitus (DM).ObjectivesTo assess the effects of ozone therapy on the healing of foot ulcers in people with DM.Search methodsIn March 2015 we searched: The Cochrane Wounds Group Specialised Register, The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library), Ovid MEDLINE, Ovid MEDLINE (In-Process & Other Non-Indexed Citations), Ovid EMBASE, EBSCO CINAHL, Science Citation Index, Chinese Biomedical Literature Database and The Chinese Clinical Registry. There were no restrictions based on language, date or study setting.Selection criteriaWe included randomised controlled trials (RCTs) that compared ozone therapy with sham ozone therapy or any other interventions for foot ulcers in people with DM, irrespective of publication date or language.Data collection and analysisTwo reviewers independently screened all retrieved citations, selected relevant citations and extracted data. Disagreements were resolved by discussion with a third reviewer. The methodological quality of included studies and the evidence level of outcomes were assessed using the Cochrane risk of bias tool and the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach respectively. Data were expressed using risk ratio (RR) for dichotomous outcomes and mean difference (MD) for continuous outcomes with their 95% confidence interval (95% CI). Review Manager (RevMan) software was used to analyse the data.Main resultsThree studies (212 participants) were included in this review. The overall risk of bias was high for two trials and unclear for one.One trial (101 participants) compared ozone treatment with antibiotics for foot ulcers in people with DM. The study had a follow-up period of 20 days. This study showed that ozone treatment was associated with a greater reduction in ulcer area from baseline to the end of the study than treatment with antibiotics (MD -20.54 cm(2), 95% CI -20.61 to -20.47), and a shorter duration of hospitalisation (MD -8.00 days, 95% CI -14.17 to -1.83), but did not appear to affect the number of ulcers healed over 20 days (RR 1.10, 95% CI 0.87 to 1.40). No side effects were observed in either group.The other two trials (111 participants) compared ozone treatment plus usual care with usual care for foot ulcers in people with DM. The meta-analysis results did not show evidence of a difference between groups for the outcomes of reduction of ulcer area (MD -2.11 cm(2), 95% CI -5.29 to 1.07), the number of ulcers healed (RR 1.69, 95% CI 0.90 to 3.17), adverse events (RR 2.27, 95% CI 0.48 to 10.79), or amputation rate (RR 2.73, 95%CI 0.12, 64.42).Authors' conclusionsThe available evidence was three small RCTs with unclear methodology, so we are unable to draw any firm conclusions regarding the effectiveness of ozone therapy for foot ulcers in people with DM.
| S-EPMC8246444 | biostudies-literature
Project description: Not available
| S-EPMC6481886 | biostudies-literature
Project description:BackgroundPressure ulcers affect approximately 10% of people in hospitals and older people are at highest risk. A correlation between inadequate nutritional intake and the development of pressure ulcers has been suggested by several studies, but the results have been inconsistent.ObjectivesTo evaluate the effects of enteral and parenteral nutrition on the prevention and treatment of pressure ulcers.Search methodsIn March 2014, for this first update, we searched The Cochrane Wounds Group Specialised Trials Register, the Cochrane Central register of Controlled Trials (The Cochrane Library), the Database of Abstracts of Reviews of Effects (DARE) (The Cochrane Library), the Health Technology Assessment Database (HTA) (The Cochrane Library), the Cochrane Methodology Register (The Cochrane Library), NHS Economic Evaluation Database (The Cochrane Library), Ovid Medline, Ovid Embase and EBSCO CINAHL. No date, language or publication status limits were applied.Selection criteriaRandomised controlled trials (RCTs) evaluating the effects of enteral or parenteral nutrition on the prevention and treatment of pressure ulcers, which measured the incidence of new ulcers, ulcer healing or changes in pressure ulcer severity. There were no restrictions on types of patient, setting, date, publication status or language.Data collection and analysisTwo review authors independently screened for inclusion, and disagreement was resolved by discussion. Two review authors independently extracted data and assessed quality using the Cochrane Collaboration tool for assessing risk of bias.Main resultsWe included 23 RCTs, many were small (between 9 and 4023 participants, median 88) and at high risk of bias.Eleven trials compared a combination of nutritional supplements, consisting of a minimum of energy and protein in different dosages, for the prevention of pressure ulcers. A meta-analysis of eight trials (6062 participants) that compared the effects of mixed nutritional supplements with standard hospital diet found no clear evidence of an effect of supplementation on pressure ulcer development (pooled RR 0.86; 95% CI 0.73 to 1.00; P value 0.05; I(2) = 13%, random effects). This outcome is at unclear or high risk of bias.Fourteen trials evaluated the effects of nutritional supplements on the healing of existing pressure ulcers: seven trials examined mixed nutritional supplements, three the effects of proteins, two trials examined zinc, and two studies examined ascorbic acid. The included trials were heterogeneous with regard to participants, interventions, comparisons and outcomes and meta-analysis was not appropriate. There was no clear evidence of an improvement in pressure ulcer healing from the nutritional supplements evaluated in any of these individual studies.Authors' conclusionsThere is currently no clear evidence of a benefit associated with nutritional interventions for either the prevention or treatment of pressure ulcers. Further trials of high methodological quality are necessary.
| S-EPMC9736772 | biostudies-literature
Project description:BackgroundThe frequency of skin ulceration makes an important contributor to the morbidity burden in people with sickle cell disease. Many treatment options are available to the healthcare professional, although it is uncertain which treatments have been assessed for effectiveness in people with sickle cell disease. This is an update of a previously published Cochrane Review.ObjectivesTo assess the clinical effectiveness and harms of interventions for treating leg ulcers in people with sickle cell disease.Search methodsWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Haemoglobinopathies Trials Register. We searched LILACS (1982 to January 2020), ISI Web of Knowledge (1985 to January 2020), and the Clinical Trials Search Portal of the World Health Organization (January 2020). We checked the reference lists of all the trials identified. We also contacted those groups or individuals who may have completed relevant randomised trials in this area. Date of the last search of the Cochrane Cystic Fibrosis and Genetic Disorders Group's Haemoglobinopathies Trials Register: 13 January 2020; date of the last search of the Cochrane Wounds Group Trials Register: 17 February 2017.Selection criteriaRandomised controlled trials of interventions for treating leg ulcers in people with sickle cell disease compared to placebo or an alternative treatment.Data collection and analysisTwo authors independently selected studies for inclusion. All three authors independently assessed the risk of bias of the included studies and extracted data. We used GRADE to assess the quality of the evidence.Main resultsSix studies met the inclusion criteria (198 participants with 250 ulcers). Each trial investigated a different intervention and within this review we have grouped these as systemic pharmaceutical interventions (L-cartinine, arginine butyrate, isoxsuprine) and topical pharmaceutical interventions (Solcoseryl® cream, arginine-glycine-aspartic acid (RGD) peptide dressing and topical antibiotics). No trials on non-pharmaceutical interventions were included in the review. All trials had an overall unclear or high risk of bias, and drug companies sponsored four of them. We were unable to pool findings due to the heterogeneity in outcome definitions, and inconsistency between the units of randomisation and analysis. Three interventions reported on the change in ulcer size (arginine butyrate, RGD peptide, L-cartinine). Of these, only arginine butyrate showed a reduction of ulcer size compared with a control group, mean reduction -5.10 cm² (95% CI -9.65 to -0.55), but we are uncertain whether this reduces ulcer size compared to standard care alone as the certainty of the evidence has been assessed as very low. Three trials reported on complete leg ulcer closure (isoxsuprine, arginine butyrate, RGD peptide matrix; very low quality of evidence). None reported a clinical benefit. No trial reported on: the time to complete ulcer healing; ulcer-free survival following treatment for sickle cell leg ulcers; quality of life measures; incidence of amputation or harms.Authors' conclusionsGiven the very low quality of the evidence identified in this updated Cochrane Review we are uncertain whether any of the assessed pharmaceutical interventions reduce ulcer size or result in leg ulcer closure in treated participants compared to controls. However, this intervention was assessed as having a high risk of bias due to inadequacies in the single trial report. Other included studies were also assessed as having an unclear or high risk of bias. The harm profile of the all interventions remains inconclusive.
| S-EPMC8407242 | biostudies-literature
Project description: Not available
| S-EPMC8665376 | biostudies-literature
Project description: Not available
| S-EPMC10666471 | biostudies-literature
Project description: Not available
| S-EPMC8627701 | biostudies-literature
Project description:BackgroundOffloading interventions are commonly used in clinical practice to heal foot ulcers. The aim of this updated systematic review is to investigate the effectiveness of offloading interventions to heal diabetic foot ulcers.MethodsWe updated our previous systematic review search of PubMed, EMBASE, and Cochrane databases to also include original studies published between July 29, 2014 and August 13, 2018 relating to four offloading intervention categories in populations with diabetic foot ulcers: (a) offloading devices, (b) footwear, (c) other offloading techniques, and (d) surgical offloading techniques. Outcomes included ulcer healing, plantar pressure, ambulatory activity, adherence, adverse events, patient-reported measures, and cost-effectiveness. Included controlled studies were assessed for methodological quality and had key data extracted into evidence and risk of bias tables. Included non-controlled studies were summarised on a narrative basis.ResultsWe identified 41 studies from our updated search for a total of 165 included studies. Six included studies were meta-analyses, 26 randomised controlled trials (RCTs), 13 other controlled studies, and 120 non-controlled studies. Five meta-analyses and 12 RCTs provided high-quality evidence for non-removable knee-high offloading devices being more effective than removable offloading devices and therapeutic footwear for healing plantar forefoot and midfoot ulcers. Total contact casts (TCCs) and non-removable knee-high walkers were shown to be equally effective. Moderate-quality evidence exists for removable knee-high and ankle-high offloading devices being equally effective in healing, but knee-high devices have a larger effect on reducing plantar pressure and ambulatory activity. Low-quality evidence exists for the use of felted foam and surgical offloading to promote healing of plantar forefoot and midfoot ulcers. Very limited evidence exists for the efficacy of any offloading intervention for healing plantar heel ulcers, non-plantar ulcers, and neuropathic ulcers with infection or ischemia.ConclusionStrong evidence supports the use of non-removable knee-high offloading devices (either TCC or non-removable walker) as the first-choice offloading intervention for healing plantar neuropathic forefoot and midfoot ulcers. Removable offloading devices, either knee-high or ankle-high, are preferred as second choice over other offloading interventions. The evidence bases to support any other offloading intervention is still weak and more high-quality controlled studies are needed in these areas.
| S-EPMC8370012 | biostudies-literature
Project description:ObjectiveHigh plantar pressures are implicated in the development of diabetes-related foot ulcers. Whether plantar pressures remain high in patients with chronic diabetes-related foot ulcers over time is uncertain. The primary aim of this study was to compare plantar pressures at baseline and three and six months later in participants with chronic diabetes-related foot ulcers (cases) to participants without foot ulcers (controls).MethodsStandardised protocols were used to measure mean peak plantar pressure and pressure-time integral at 10 plantar foot sites (the hallux, toes, metatarsals 1 to 5, mid-foot, medial heel and lateral heel) during barefoot walking. Measurements were performed at three study visits: baseline, three and six months. Linear mixed effects random-intercept models were utilised to assess whether plantar pressures differed between cases and controls after adjusting for age, sex, body mass index, neuropathy status and follow-up time. Standardised mean differences (Cohen's d) were used to measure effect size.ResultsTwenty-one cases and 69 controls started the study and 16 cases and 63 controls completed the study. Cases had a higher mean peak plantar pressure at several foot sites including the toes (p = 0.005, Cohen's d = 0.36) and mid-foot (p = 0.01, d = 0.36) and a higher pressure-time integral at the hallux (p<0.001, d = 0.42), metatarsal 1 (p = 0.02, d = 0.33) and mid-foot (p = 0.04, d = 0.64) compared to controls throughout follow-up. A reduction in pressure-time integral at multiple plantar sites over time was detected in all participants (p<0.05, respectively).ConclusionsPlantar pressures assessed during gait are higher in diabetes patients with chronic foot ulcers than controls at several plantar sites throughout prolonged follow-up. Long term offloading is needed in diabetes patients with diabetes-related foot ulcers to facilitate ulcer healing.
| S-EPMC5578502 | biostudies-literature
Project description:BACKGROUND:Pediatric medical conditions have the potential to result in challenging psychological symptoms (eg, anxiety, depression, and posttraumatic stress symptoms [PTSS]) and impaired health-related quality of life in youth. Thus, effective and accessible interventions are needed to prevent and treat psychological sequelae associated with pediatric medical conditions. Electronic health (eHealth) interventions may help to meet this need, with the capacity to reach more children and families than in-person interventions. Many of these interventions are in their infancy, and we do not yet know what key components contribute to successful eHealth interventions. OBJECTIVE:The primary objective of this study was to conduct a systematic review to summarize current evidence on the efficacy of eHealth interventions designed to prevent or treat psychological sequelae in youth with medical conditions. METHODS:MEDLINE (PubMed) and PsycINFO databases were searched for studies published between January 1, 1998, and March 1, 2019, using predefined search terms. A total of 2 authors independently reviewed titles and abstracts of search results to determine which studies were eligible for full-text review. Reference lists of studies meeting eligibility criteria were reviewed. If the title of a reference suggested that it might be relevant for this review, the full manuscript was reviewed for inclusion. Inclusion criteria required that eligible studies (1) had conducted empirical research on the efficacy of a Web-based intervention for youth with a medical condition, (2) had included a randomized trial as part of the study method, (3) had assessed the outcomes of psychological sequelae (ie, PTSS, anxiety, depression, internalizing symptoms, or quality of life) in youth (aged 0-18 years), their caregivers, or both, (4) had included assessments at 2 or more time points, and (5) were available in English language. RESULTS:A total of 1512 studies were reviewed for inclusion based on their title and abstracts; 39 articles qualified for full-text review. Moreover, 22 studies met inclusion criteria for the systematic review. Of the 22 included studies, 13 reported results indicating that eHealth interventions significantly improved at least one component of psychological sequelae in participants. Common characteristics among interventions that showed an effect included content on problem solving, education, communication, and behavior management. Studies most commonly reported on child and caregiver depression, followed by child PTSS and caregiver anxiety. CONCLUSIONS:Previous research is mixed but suggests that eHealth interventions may be helpful in alleviating or preventing problematic psychological sequelae in youth with medical conditions and their caregivers. Additional research is needed to advance understanding of the most powerful intervention components and to determine when and how to best disseminate eHealth interventions, with the goal of extending the current reach of psychological interventions.
| S-EPMC6878107 | biostudies-literature