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Therapeutic efficacy of ozone in patients with diabetic foot. Eur J Pharmacol. 2005 Sep 27
Martinez-Sanchez G, Al-Dalain SM, Menendez S, Re L, Giuliani A, Candelario-Jalil E, Alvarez H, Fernandez-Montequin JI, Leon OS.
Center of Studies for Research and Biological Evaluation (CEIEB-IFAL), University of Havana, Havana 10400, Cuba.
Oxidative stress is suggested to have an important role in the development of complications in diabetes. Because ozone therapy can activate the antioxidant system, influencing the level of glycemia and some markers of endothelial cell damage, the aim of this study was to investigate the therapeutic efficacy of ozone in the treatment of patients with type 2 diabetes and diabetic feet and to compare ozone with antibiotic therapy. A randomized controlled clinical trial was performed with 101 patients divided into two groups: one (n=52) treated with ozone (local and rectal insufflation of the gas) and the other (n=49) treated with topical and systemic antibiotics. The efficacy of the treatments was evaluated by comparing the glycemic index, the area and perimeter of the lesions and biochemical markers of oxidative stress and endothelial damage in both groups after 20 days of treatment. Ozone treatment improved glycemic control, prevented oxidative stress, normalized levels of organic peroxides, and activated superoxide dismutase. The pharmacodynamic effect of ozone in the treatment of patients with neuroinfectious diabetic foot can be ascribed to the possibility of it being a superoxide scavenger. Superoxide is considered a link between the four metabolic routes associated with diabetes pathology and its complications. Furthermore, the healing of the lesions improved, resulting in fewer amputations than in control group. There were no side effects. These results show that medical ozone treatment could be an alternative therapy in the treatment of diabetes and its complications.
The Hyperbaric Chamber at Prince of Wales Hospital at Randwick has had excellent results with ulcer treatments over the past 10 years + using Oxygen Therapy. The patient is in the chamber for about 3 hours per session.
Treatment for White Tail Spider bites where severe ulceration has occurred.
Rapid healing of fractures
There are disadvantages
Possible rupture of ear drum very minor occurance
Hyperbaric Oxygen and Innocent White Tailed Spider
I too have seen some good results from Hyperbaric Therapy, but is it the oxygen or the fact that they are resting and recieving intense care and committed etc. to spending 3 hours 3 times or more per week for upto 6 weeks in a decompression chamber?
No one has done the randomised control trial yet!
Re: the white tail spider. It has been shown to be an innocent bystander in the causation of these necrotising ulcers. The ABC Catalyst show reports on its innocence, all ulcers in this study traced back to something else: a range of conditions from Golden Staf infections, infected ulcers even one case of skin cancer...and all misidentified by doctors as White Tailed Spider bites.
I have had at least five patient who were bitten by the White Tail Spider and they all had ulcerations around the bite site. They were sent to P of W for Tx.
There is one theory that this spider has the ability to take on the venom of the spiders it devours.
The hyperbacric chamber at Prince of Wales Hospital (Randwick Sydney) is used for diver recovery, Pseudoarthitis, crush fractures, ulcer management, sports injuries (See today's Sunday Telegraph Balmain Footballer had several sessions page 55. He also had 11 needles) and in special cased they can conduct major surgery inside the chamber. The chamber can seat up to six patients. It's bloody big and it was run by qualified Hyperbaric Doctor (Dr Michael Bennett) and specially trained nursing staff.
100% Oxygen therapy does not need any more randomised trial. I have 1996 publications from USA and Australia on Hyperbaric Medicine
Current acute applications for HBOT are
Acute smoke inhalation, Decompression Sickness, Osteomyelitis, Air or Gas Embolism, Exceptional Blood Loss, Gas gangrene, Cyanide posioning, Anaerobic infections
Don, There may be trials re: decompression sickness, smoke inhalation etc. but none that I am aware of for wound healing. Yes there is alot published, but mainly case studies. There are some studies using the VACS which "pulls"
blood and oxygen to a wound.
And the white tailed spider is incapable of causing a necrotising ulcer, as the previous links stated.
Re Ozone therapy, I use to use it 18 years ago primarily in the treatment of venous leg ulcers before it was realised that compression therapy worked much better.
We used a box that covered the wound and was connected into an Ozone generating machine that plugged into the wall
__________________ Stephen Tucker
Manager, Specialist Clinics
Is Ozone theraputic? I was under the impression that Ozone (03) inhibited wound healing.
Ref; Toxicol Lett. 2005 Aug 26;
Modulation of cutaneous wound healing by ozone: Differences between young and aged mice.
Lim Y, Phung AD, Corbacho AM, Aung HH, Maioli E, Reznick AZ, Cross CE, Davis PA, Valacchi G.
Department of Internal Medicine, School of Medicine, UC Davis, Davis CA, USA.
Cutaneous tissues are frequently exposed to prooxidative environments, including UV radiation and air pollutants. Among the latter, ozone (O(3)) is of particular concern because of its high and dominating presence in photochemical smog. It is well known that O(3) depletes small molecular weight antioxidants, oxidizes proteins, induces lipid peroxidation and activates cellular responses in various tissues. Using an in vivo model (SKH-1 hairless mice), the interaction between O(3) exposure (0.5ppmx6h/day) and age was examined in relation to cutaneous wound healing. Compared to younger (8 weeks) mice, older (18 months) mice exposed to O(3) (day 0 to day 9 after wounding) exhibited delayed wound closure, increased lipid peroxidation (measured as 4-HNE protein adducts) and protein oxidation (measured as carbonyls concentration) and decreased levels of P-IkappaBalpha and TGFbeta protein. These findings support the hypothesis that oxidant pollutant exposure and age interact so as to disrupt normal wound healing processes.
Background: 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.
Methods: 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.
Results: 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 completed the study per protocol (PP) (16 in the ozone group, 18 in the placebo group), a significantly higher rate of complete wound closure was observed in the ozone group (81% vs. 44%, P=0.03). Among PP patients with wound size ≤5 cm(2), the rate of total wound closure was 100% versus 50% in the sham treatment group (P=0.006). A nonsignificant, 55.5% relative increase in healed wound area was detected in the ozone group versus the placebo group (4.2±4.9 cm(2) vs. 2.7±1.5 cm(2), P=0.23).
Conclusions: Among PP patients, ozone treatment in addition to conventional treatment was superior to conventional treatment alone in promoting the complete healing of diabetic foot ulcers.
Adequate tissue oxygenation is an essential factor in diabetic foot management. Hyperbaric oxygen (HBO) therapy has been successfully used as adjunctive treatment to improve the healing of diabetic foot ulcers. However, the clinical uses of HBO therapy are limited due to the low availability of HBO chambers, poor patient compliance, and high oxidative potential. Normobaric hyperoxic (NBO) therapy may be a potentially attractive alternative to HBO therapy because of its high availability, good patient compliance, and few technical requirements. Several studies on NBO therapy to attenuate infarct volume after stroke have provided compelling evidence. However, there have been no reports regarding the effect of NBO therapy in the field of wound healing. The purpose of this study was to evaluate the effect of NBO therapy on tissue oxygenation of diabetic feet. This study included 100 patients with diabetic foot ulcers (64 males and 36 females). Transcutaneous partial oxygen tension (TcPO2) values of diabetic feet were measured before, during, and after NBO therapy. The mean TcPO2 values before, during, and after therapy were 46.6 ± 21.5, 88.9 ± 48.0, and 49.9 ± 23.8 mmHg (p < 0.001), respectively. The lower the initial TcPO2 level, the more TcPO2 increased. The results reveal that NBO therapy significantly increases tissue oxygenation level of diabetic feet.
Re: Efficacy of ozone in patients with diabetic foot ulcers
Increased growth factors play a role in wound healing promoted by noninvasive oxygen-ozone therapy in diabetic patients with foot ulcers.
Zhang J, Guan M, Xie C, Luo X, Zhang Q, Xue Y. Oxid Med Cell Longev. 2014;2014:273475.
Management of diabetic foot ulcers (DFUs) is a great challenge for clinicians. Although the oxygen-ozone treatment improves the diabetic outcome, there are few clinical trials to verify the efficacy and illuminate the underlying mechanisms of oxygen-ozone treatment on DFUs. In the present study, a total of 50 type 2 diabetic patients complicated with DFUs, Wagner stage 2~4, were randomized into control group treated by standard therapy only and ozone group treated by standard therapy plus oxygen-ozone treatment. The therapeutic effects were graded into 4 levels from grade 0 (no change) to grade 3 (wound healing). The wound sizes were measured at baseline and day 20, respectively. Tissue biopsies were performed at baseline and day 11. The expressions of vascular endothelial growth factor (VEGF), transforming growth factor-β (TGF-β), and platelet-derived growth factor (PDGF) proteins in the pathologic specimens were determined by immunohistochemical examinations. The effective rate of ozone group was significantly higher than that of control group (92% versus 64%, P < 0.05). The wound size reduction was significantly more in ozone group than in control group (P < 0.001). After treatment, the expressions of VEGF, TGF-β, and PDGF proteins at day 11 were significantly higher in ozone group than in control group. Ozone therapy promotes the wound healing of DFUs via potential induction of VEGF, TGF-β, and PDGF at early stage of the treatment.
It has been reported that ozone therapy might be helpful in treating foot ulcers in people with diabetes mellitus (DM).
To assess the effects of ozone therapy on the healing of foot ulcers in people with DM.
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.
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.
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 cm2, 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 cm2, 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).
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.