Dataset Information

Ozone therapy for treating foot ulcers in people with diabetes.

ABSTRACT:

Background

It has been reported that ozone therapy might be helpful in treating foot ulcers in people with diabetes mellitus (DM).

Objectives

To assess the effects of ozone therapy on the healing of foot ulcers in people with DM.

Search methods

In 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 criteria

We 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 analysis

Two 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 results

Three 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' conclusions

The 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.

SUBMITTER: Liu J

PROVIDER: S-EPMC8246444 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

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.

Project description:BackgroundDiabetes related foot ulcers can have physical, social, emotional, and financial impacts on the daily life and wellbeing of many people living with diabetes. Effective treatment of diabetes related foot ulcers requires a multi-faceted, multi-disciplinary approach involving a podiatrist, other healthcare professionals, and the person with diabetes however, limited research has been conducted on the lived experience of podiatric treatment for diabetes related foot ulcers to understand how people are engaged in their ulcer management. Therefore, this study aimed to explore the lived experience of receiving podiatric treatment for diabetes related foot ulcers in a tertiary care outpatient setting.MethodsTen participants were interviewed. All were male, with mean age of 69 (SD 15) years and currently undergoing podiatric treatment for a diabetes related foot ulcer in a tertiary care setting. Participants with diabetes related foot ulcers were purposively recruited from the outpatient podiatry clinic at a tertiary hospital in a metropolitan region of South Australia. Semi-structured interviews were conducted to gain insight into the lived experience of people receiving podiatric treatment for their foot ulcer and understand how this experience impacts their regular lifestyle. Data were analysed using a thematic analysis method.ResultsFour themes were identified that add an understanding of the lived experience of participants: 'Trusting the podiatrists with the right expertise', 'Personalised care', 'Happy with the service, but not always with prescribed care', and 'It's a long journey'. Participants described professional behaviour including high organisation and hygiene practices and demonstrated expertise as key factors influencing their trust of a podiatrist's care. Information tailored to individual needs was helpful for participants. Offloading devices and ulcer dressings were often burdensome. Podiatric treatment for foot ulcers was a lengthy and onerous experience for all participants.ConclusionsThe findings of this study suggest podiatrists can use practical strategies of maintaining consistency in who provides podiatry care for the person, demonstration of high organisational and hygiene standards, and using innovation to adapt information and equipment to suit an individual's lifestyle to support positive experiences of podiatric ulcer care. There is a need for further research to understand how a person's experience of podiatric ulcer care differs amongst genders, cultural groups, and healthcare settings to facilitate positive care experiences and reduce treatment burden for all people with diabetes requiring podiatric ulcer treatment.