scholarly journals Efficacy of hyperbaric oxygen therapy for diabetic foot ulcer, a systematic review and meta-analysis of controlled clinical trials

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Rakesh Sharma ◽  
Suresh K. Sharma ◽  
Shiv Kumar Mudgal ◽  
Prasuna Jelly ◽  
Kalpana Thakur

AbstractStudies have suggested that hyperbaric oxygen therapy (HBOT) is effective in the healing of diabetic foot ulcer (DFU); however, there is a lack of consensus. Therefore, to assess the efficacy of HBOT on diabetic foot ulcer among diabetic patients, controlled clinical trials were searched through PubMed, EMBASE, Clinical key, Ovid Discovery, ERMED, Clinical Trials.gov databases for randomized controlled trials (RCTs) and other sources until 15 September 2020. Studies that evaluated the effect of HBOT on diabetic foot ulcer, complete healing, amputation, adverse events, ulcer reduction area, and mortality rate were included. Of 1984 study records screened, 14 studies (768 participants) including twelve RCTs, and two CCTs were included as per inclusion criteria. The results with pooled analysis have shown that HBOT was significantly effective in complete healing of diabetic foot ulcer (OR = 0.29; 95% CI 0.14–0.61; I2 = 62%) and reduction of major amputation (RR = 0.60; 95% CI 0.39–0.92; I2 = 24%). Although, it was not effective for minor amputations (RR = 0.82; 95% CI 0.34–1.97; I2 = 79%); however, less adverse events were reported in standard treatment group (RR = 1.68; 95% CI 1.07–2.65; I2 = 0%). Nevertheless, reduction in mean percentage of ulcer area and mortality rate did not differ in HBOT and control groups. This review provides an evidence that hyperbaric oxygen therapy is effective as an adjunct treatment measure for the diabetes foot ulcers. These findings could be generalized cautiously by considering methodological flaws within all studies.

BMJ Open ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. e031708 ◽  
Author(s):  
Julie Vinkel ◽  
Niels Frederich Rose Holm ◽  
Janus C Jakobsen ◽  
Ole Hyldegaard

IntroductionDiabetic foot ulcer represents a major health problem globally. Preliminary studies have indicated that systemic treatment of diabetic foot ulcer patients with hyperbaric oxygen therapy have beneficial effects on wound healing, risk of amputation, glycaemic control, atherosclerosis, inflammatory markers and other clinical and laboratory parameters. This protocol for a systematic review aims at identifying the beneficial and harmful effects of adding hyperbaric oxygen therapy to standard wound care for diabetic foot ulcers.Methods and analysisThis protocol was performed following the recommendations of the Cochrane Collaboration and the eight-step assessment procedure suggested by Jakobsen and colleagues. We plan to include all relevant randomised clinical trials assessing the effects of hyperbaric oxygen therapy in the treatment of diabetic foot ulcer versus any control group with any intervention defined as standard wound care or similar, together with sham interventions. Our primary outcome will be: all-cause mortality, serious adverse events and quality of life. Our secondary outcomes will be: healing of index wound, major amputation and wound infection. Any eligible trial will be assessed and classified as either high risk of bias or low risk of bias, and our conclusions will be based on trials with low risk of bias. The analyses of the extracted data will be performed using Review Manager 5 and Trial Sequential Analysis. For both our primary and secondary outcomes, we will create a ‘Summary of Findings’ table and use GRADE (Grading of Recommendations Assessment, Development and Evaluation) assessment to assess the quality of the evidence.Ethics and disseminationWe use publicly accessible documents as evidence, there is no participant involvement at an individual level and an institutional ethics approval is not required. The results of the review will be sought published in a peer-reviewed journals, also in the event of insignificant results or null results, and thereby it will be disseminated to clinicians and public available.PROSPERO registration numberCRD42019139256.


Diabetes Care ◽  
1996 ◽  
Vol 19 (12) ◽  
pp. 1338-1343 ◽  
Author(s):  
E. Faglia ◽  
F. Favales ◽  
A. Aldeghi ◽  
P. Calia ◽  
A. Quarantiello ◽  
...  

Diabetes Care ◽  
2013 ◽  
Vol 36 (7) ◽  
pp. 1961-1966 ◽  
Author(s):  
D. J. Margolis ◽  
J. Gupta ◽  
O. Hoffstad ◽  
M. Papdopoulos ◽  
H. A. Glick ◽  
...  

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