Effectiveness of topical oxygen therapy in wound healing for patients with diabetic foot ulcer (original) (raw)
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OBJECTIVE Topical oxygen has been used for the treatment of chronic wounds for more than 50 years. Its effectiveness remains disputed due to the limited number of robust high-quality investigations. The aim of this study was to assess the efficacy of multimodality cyclical pressure Topical Wound Oxygen (TWO2) home care therapy in healing refractory diabetic foot ulcers (DFUs) that had failed to heal with standard of care (SOC) alone. RESEARCH DESIGN AND METHODS Patients with diabetes and chronic DFUs were randomized (double-blind) to either active TWO2 therapy or sham control therapydboth in addition to optimal SOC. The primary outcome was the percentage of ulcers in each group achieving 100% healing at 12 weeks. A group sequential design was used for the study with three predetermined analyses and hard stopping rules once 73, 146, and ultimately 220 patients completed the 12-week treatment phase. RESULTS At the first analysis point, the active TWO2 arm was found to be superior to the sham arm, with a closure rate of 41.7% compared with 13.5%. This difference in outcome produced an odds ratio (OR) of 4.57 (97.8% CI 1.19, 17.57), P 5 0.010. After adjustment for University of Texas Classification (UTC) ulcer grade, the OR increased to 6.00 (97.8% CI 1.44, 24.93), P 5 0.004. Cox proportional hazards modeling, also after adjustment for UTC grade, demonstrated >4.5 times the likelihood to heal DFUs over 12 weeks compared with the sham arm with a hazard ratio of 4.66 (97.8% CI 1.36, 15.98), P 5 0.004. At 12 months postenrollment, 56% of active arm ulcers were closed compared with 27% of the sham arm ulcers (P 5 0.013). CONCLUSIONS This sham-controlled, double-blind randomized controlled trial demonstrates that, at both 12 weeks and 12 months, adjunctive cyclical pressurized TWO2 therapy was superior in healing chronic DFUs compared with optimal SOC alone. Clinical trial reg. no. NCT02326337, clinicaltrials .gov. This article contains Supplementary Data online at https://care.diabetesjournals.org/lookup/suppl/
Advances in Wound Care
Objective: To conduct a systematic review and meta-analysis of recently published randomized controlled trials (RCTs) that employed the use of topical oxygen therapy (TOT) as an adjunct therapy in the treatment of Wagner 1 and 2 diabetic foot ulcers. Approach: Following a literature search of eligible studies from 2010 onward, four RCTs were included. Studies were analyzed for patient and wound characteristics, outcomes, risk of bias, and quality of the evidence assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology. A random-effects meta-analysis for complete wound healing was carried out due to statistical heterogeneity of included studies. Results: Risk of bias judgment (RoB2 analysis) resulted in one low-risk trial and three trials with some risk. One study was determined to be the origin of the statistical heterogeneity. Pooled results showed statistical significance with a risk ratio (RR) of 1.59 (95% confidence interval [CI]: 1.07-2.37; p = 0.021). Sensitivity analysis, based on imputed values for missing outcomes, demonstrated that both the RR and 95% CIs changed little. The GRADE ratings for each domain were as follows: (a) risk of bias: moderate (3); (b) imprecision: moderate (2), high (1); (c) inconsistency: low (2), high (1); (d) indirectness: moderate (2), high (1); and (e) publication bias: moderate (1), high (2). Overall, the evidence was moderate. Innovation: Our study shows that TOT is a viable diabetic foot ulcer therapy. Conclusions: These data support the use of TOT for the treatment of chronic Wagner 1 or 2 diabetic foot ulcers in the absence of infection and ischemia.
PubMed, 2013
Hypoxia is a major factor in delayed wound healing. The aim of this prospective, randomized, clinical trial was to compare outcomes of treatment in persons with chronic diabetic foot ulcers (DFUs) randomly assigned to transdermal continuous oxygen therapy (TCOT) for 4 weeks as an adjunct to standard care (debridement, offloading, and moisture). Nine patients (age 58.6±7.1, range 38-73 years) received TCOT (treatment group) and eight patients (age 59.9±12.6, range 35-76 years) received standard care alone (control group). Most patients (12) were male, and all had a Wagner I or II foot ulcer for an average of 14 (control group) or 20 months (treatment group). Weekly wound measurements and wound tissue biopsies were obtained and wound fluid collected. Levels of pro-inflammatory cytokines and proteases in wound fluid samples were analyzed using Luminex-based multiplex assays. Tissue-resident macrophages were quantified by immunohistochemistry. At week 4, average wound size reduction was 87% (range 55.7% to 100%) in the treatment group compared to 46% (15% to 99%) in the control group (P <0.05). Changes in cytokine levels (IL-6, IL-8) and proteinases (MMP-1,-2,-9, TIMP-1) at weeks 2 to 4 in wound fluid correlated with clinical findings. CD68+ macrophage counts showed statistically significant reduction in response to TCOT compared to the control group (P <0.01). The results of this study show that TCOT may facilitate healing of DFUs by reversing the inflammatory process through reduction in pro-inflammatory cytokines and tissue-degrading proteases. Additional research to elucidate the effects of this treatment on complete healing and increase understanding about the role of wound fluid analysis is needed.
Dermatologic Therapy
Diabetes mellitus is one of the most common metabolic diseases in which one of the most serious complications is the diabetic foot ulcer (DFU). The aim of the study was to compare the efficacy of two physical therapeutic methods: topical oxygen therapy and topical ozone therapy in the treatment of DFU with the calculation of the financial costs for both applied physical methods. The study included 85 patients, 47 male (55.2%) and 38 female (44.7%) in age range between 40 and 90 years (mean age: 67.82 ± 12.42 years) with hard to heal diabetic foot ulcers. The mean diabetic foot ulcer duration was 3.6 ± 1.23 years. Patients were randomized into two study groups not significantly different in terms of age, body mass index (BMI) value, and baseline ulcer surface area value, who underwent topical oxygen therapy (group I) and topical ozone therapy (group II), respectively. Both the groups underwent a total of 30 daily treatments lasting 30 minutes, in 2 sessions of 15 treatments with a 14...
Efficacy of ozone-oxygen therapy for the treatment of diabetic foot ulcers
Diabetes technology & therapeutics, 2011
Diabetic foot ulcers are associated with significant morbidity. Conventional treatment modalities are often of limited success in promoting complete wound closure. The aim of the present study was to examine the efficacy of noninvasive ozone-oxygen therapy in the treatment of diabetic foot ulcers. Diabetes patients with a Wagner classification stage 2 or 3 ulcer or a stage 4 ulcer after debridement of at least 8 weeks in duration were included in this double-blind, randomized, placebo-controlled clinical trial. Patients received conventional treatment in combination with either ozone-oxygen treatment or sham treatments for 12 weeks, and after an additional 12 weeks, wound status was re-examined. In total, 61 patients (62% male, 62.6±9.8 years old) participated in the study; 32 were randomized to ozone treatment, and 29 to placebo. The proportion of subjects with full wound closure did not differ significantly by treatment assignment (41% vs. 33%, P=0.34). Among the 34 subjects who c...
Journal of wound, ostomy, and continence nursing : official publication of The Wound, Ostomy and Continence Nurses Society
The purpose of this study was to compare the effect of standard wound care with adjunctive hyperbaric oxygen therapy (HBOT) to standard wound care alone on wound healing, markers of inflammation, glycemic control, amputation rate, survival rate of tissue, and health-related quality of life in patients with diabetic foot ulcers (DFUs). Prospective, randomized, open-label, controlled study. The sample comprised 38 patients with nonhealing DFUs who were deemed poor candidates for vascular surgery. Subjects were randomly allocated to an experimental group (standard care plus HBOT, n = 20) or a control group (standard care alone, n = 18). The study setting was a medical center in Kaohsiung City, Taiwan. Hyperbaric oxygen therapy was administered in a hyperbaric chamber under 2.5 absolute atmospheric pressure for 120 minutes; subjects were treated 5 days a week for 4 consecutive weeks. Both groups received standard wound care including debridement of necrotic tissue, topical therapy for W...
Diabetes mellitus (DM) is a metabolic disease in which the body has difficulty producing insulin which leads to high blood glucose levels. Consequently, people suffering from DM can have damage organs, blood vessels, and nerves which resulting in getting diabetic foot ulcer (DFU). Other therapeutic interventions are offered if the DFU does not heal with normal standard wound care. One of which is hyperbaric oxygen therapy (HBOT) that will increase the oxygen supply to wounds. However, the effectiveness of this therapy is not clearly known till present. Thus, the review of this paper aimed to report on the results of analysis of research that focuses on the effect HBOT on diabetic foot ulcer healing. Relevant literature was searched in Google Scholar and PubMed used keywords "hyperbaric oxygen therapy" "diabetic foot ulcer" "wound healing", and "chronic ulcer". Five articles that met the inclusion criteria based on the results of the analysis. Although there was some indication of a beneficial effect of wound healing process, it is currently unknown which patients are likely to benefit from HBOT and which patients are not. KEYWORD: hyperbaric oxygen therapy, diabetic foot ulcer, wound healing
Effect of Different Therapeutic Modalities on Healing Rate of Diabetic Foot Ulcers
2008
Background and purpose: About 15% of diabetic patients experience a foot ulcer in their life. Foot ulcers are a major predictor of future lower extremity amputation in patients with diabetes, as about 14 to 24% of patients with foot ulcer require amputation. The purpose of this study was to determine which therapeutic method out from hyperbaric oxygen therapy; laser and ultrasound, in addition to medical treatment obtain the best improvement in healing rate of foot ulcers in diabetic patients. Subjects and methods: Forty-five non-insulin dependent diabetic patients of both sexes complicated with foot ulcer grade II. Their age ranged from 42 to56 years. They were selected from Nasser Institute and randomly assigned into 3 equal groups. Group (1) received laser therapy, group (2) received hyperbaric oxygen therapy and group (3) received the pulsed ultrasound therapy in addition to medical treatment. Measurement of ulcer surface area and volume for all patients in the three groups was done before treatment and after two months at the end of the study. Results: There was a significant difference between group (1) & (2) and group (1) & (3). Where there was no significant difference between group (2) & (3). Conclusion: It is recommended to use hyperbaric oxygen therapy in addition to medical treatment to accelerate healing rate of foot ulcers in diabetic patients.