Topical hyperbaric oxygen and low-energy laser treatment

NewsBot · Jun 10, 2006

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Topical hyperbaric oxygen and low-energy laser for the treatment of chronic ulcers.
Eur J Intern Med. 2006 Jul;17(4):272-5

BACKGROUND: Diabetic foot ulcers (DFU) and chronic venous ulcers (CVU) are persistent cutaneous lesions that are difficult to treat and heal. Topical hyperbaric oxygen (THO) and low-energy laser (LEL) are therapies that have been employed separately for ulcer treatment, but their concomitant use has not been investigated.

METHODS: In this unblinded, open-label non-randomized trial, we treated 374 consecutive patients with treatment-refractory chronic ulcers (218 patients with DFU and 156 individuals with CVU) with a combination of THO and LEL. THO was administered by pumping 100% oxygen into a disposable, sealed polyethylene chamber for 2 h, two to three times weekly. LEL was administered concurrently using a helium-neon laser at 4 J/cm(2) for 20 min.

RESULTS: Complete ulcer closure was obtained in 78% of patients in each group (170 patients with DFU and 127 patients with CVU). Treatment failure resulting in amputation in DFU was seen in 48 patients (22%); non-closure of ulcers within 18 months in individuals with CVU was seen in 29 (22%). The length of therapy was also similar in the two groups (3.7+/-3 versus 4.1+/-3 months in DFU and CVU cohorts, respectively). However, the number of treatments required to affect healing was greater in the CVU group than among the DFU patients (40+/-25 versus 31.4+/-20 treatments).

CONCLUSION: THO and LEL therapies are safe, effective, simple and inexpensive therapies for DFU and CVU. Confirmation must await the performance of double-blind, randomized, controlled trials currently under way
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Admin2 · Jun 10, 2006

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admin · Mar 31, 2009

This clinical trial has just been registered:

Evaluation of Topical Wound Oxygen (two2) Therapy

The purpose of this study is to evaluate the efficacy of the Topical Wound Oxygen (two2) therapy system on the healing of diabetic lower extremity ulcers.
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NewsBot · Jun 23, 2010

Topical wound oxygen therapy in the treatment of severe diabetic foot ulcers: a prospective controlled study.
Blackman E, Moore C, Hyatt J, Railton R, Frye C.
Ostomy Wound Manage. 2010 Jun;56(6):24-31.

Diabetic foot ulcers (DFU) are common, difficult-to-treat, and prone to complications. A prospective, controlled study was conducted to: 1) examine the clinical efficacy of a pressurized topical oxygen therapy (TWO2) device in outpatients (N = 28) with severe DFU referred for care to a community wound care clinic and 2) assess ulcer reoccurrence rates after 24 months. Seventeen (17) patients received TWO2 five times per week (60-minute treatment, pressure cycles between 5 and 50 mb) and 11 selected a silver-containing dressing changed at least twice per week (control). Patient demographics did not differ between treatment groups but wounds in the treatment group were more severe, perhaps as a result of selection bias. Ulcer duration was longer in the treatment (mean 6.1 months, SD 5.8) than in the control group (mean 3.2 months, SD 0.4) and mean baseline wound area was 4.1 cm2 (SD 4.3) in the treatment and 1.4 cm2 (SD 0.6) in the control group (P = 0.02). Fourteen (14) of 17 ulcers (82.4%) in the treatment group and five of 11 ulcers (45.5%) in the control group healed after a median of 56 and 93 days, respectively (P = 0.04). No adverse events were observed and there was no reoccurrence at the ulcer site after 24 months' follow-up in either group. Although the absence of randomization and blinding may have under- or overestimated the treatment effect of either group, the significant differences in treatment outcomes confirm the potential benefits of TWO2 in the management of difficult-to-heal DFUs. Clinical efficacy and cost-effectiveness studies as well as studies to elucidate the mechanisms of action of TWO2 are warranted
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NewsBot · Dec 10, 2014

This clinical trial was just registered:
Topical Oxygen Therapy for Diabetic Foot Ulcers (TOFU)

This study is to observe the effect of application of topically administered oxygen on healing rate, cost of care and rate of amputations in diabetic patients with foot ulcer(s) (DFU). The proposed study is a pragmatic (comparative effectiveness research, CER) study, in which the effectiveness of topical oxygen (100%) administered 4 days per week, for 16 weeks, for the treatment of diabetic foot ulcer (DFU) will be measure and compared with standard of care (SoC) treatment. There will be a 2 patient groups (including a comparison groups and a treatment groups) including: (1) Medicaid patients who are at Wagner grade 2 and below, will only receive standard treatment (2) Medicaid patients who are at Wagner grade 2 and below, will receive standard treatment plus Topical Oxygen Therapy. All of the Topical Oxygen Therapy will be provided in a home care setting or extended care facility.100 patients will be recruited.

This study is to assist the Ohio Department of Medicaid (ODM) and to provide efficient and effective administration of the Medicaid program.

This is an observational and descriptive study that will seek to generate a hypothesis. Due to the small sample size this study will primarily be a feasibility study that will attempt to measure and evaluate differences in the relative costs of the intervention of topical oxygen therapy on this population and subsequently compare outcomes in areas such as overall health improvements and cost effectiveness. The patient population will consist of Medicaid beneficiaries with DFU at Wagner grades 2 and below who are enrolled in the United Health Care Community Plan of Ohio (UHC).
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NewsBot · Oct 13, 2016

Topical Oxygen Therapy Results in Complete Wound Healing in Diabetic Foot Ulcers.
Yu J et al
Wound Repair Regen. 2016 Oct 12. doi: 10.1111/wrr.12490

Diabetic foot ulcers (DFUs) are a significant problem in an aging population. 15% of diabetics develop a DFU over their lifetime, which can lead to potential amputation. The 5-year survival rate after amputation is 31%, which is greater than the lifetime risk of mortality from cancer. Topical oxygen is a promising technique for the adjunctive therapy of chronic wounds including DFUs, but few controlled studies exist to support its clinical adoption. The aim of this study was to compare a portable topical oxygen delivery system in patients with non-healing DFUs to standard best practice. 20 patients were randomized into a topical oxygen group (n=10), and a non- placebo control group with regular dressings and standard care (n=10), and attended the diabetic foot clinic once weekly for 8 weeks. Ulcer surface area over time was analysed using standardized digital imaging software. DFUs were present without healing for a mean duration of 76 weeks prior to the study. We found a significant difference in healing rate between patients receiving topical oxygen and those receiving standard care. Topical oxygen therefore represents a potentially exciting new technology to shorten healing time in patients with non-healing DFUs. More prospective randomized and powered studies are needed to determine the benefits of topical oxygen, but our current results are very promising
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NewsBot · Jan 5, 2018

Topical oxygen therapy & micro/nanobubbles: a new modality for tissue oxygen delivery
Lohrasb R Sayadi, et al
International Wound Journal: 5 January 2018

Up to 15 billion dollars of US health care expenditure each year is consumed by treatment of poorly healing wounds whose etiologies are often associated with aberrancies in tissue oxygenation. To address this issue, several modes of tissue oxygen delivery systems exist, including Hyperbaric Oxygen Therapy (HBOT) and Topical Oxygen Therapy (TOT), but their efficacies have yet to be fully substantiated. Micro/nanobubbles (MNBs), which range anywhere from 100 μm to <1 μm in diameter and are relatively stable for hours, offer a new mode of oxygen delivery to wounds. The aim of this article is to systematically review literature examining the use of TOT for wound healing and use of MNBs for tissue oxygenation using the MEDLINE database. The search yielded 87 articles (12 MNB articles and 75 TOT articles), of which 52 met the inclusion criteria for this literature review (12 MNB articles and 40 TOT articles). Additionally, we present an analysis on the efficacy of our MNB generating technology and propose its use as a wound healing agent.
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NewsBot · Jan 11, 2020

Application of Topical Oxygen Therapy in Healing Dynamics of Diabetic Foot Ulcers - A Systematic Review.
Nataraj M et al
Rev Diabet Stud. 2019;15:74-82

BACKGROUND:
Individuals with diabetes may develop diabetic foot ulcers due to diabetic peripheral neuropathy. Multiple factors influence the ulcer healing process; oxygen helps in facilitating the different stages of wound healing.

OBJECTIVE:
The objective of this systematic review was to analyze the different levels of evidence available in the application of topical oxygen therapy, warm oxygen therapy, or other modes of topical oxygen delivery in the healing dynamics of diabetic foot ulcers.

METHODS:
Databases searched included Pubmed/Medline, Science Direct, Web of Science, Scopus, Cochrane, and CINAHL. The eligibility criteria of studies included participants ≥18 years with chronic non-healing diabetic foot ulcer (duration ≥3 months) receiving warm oxygen or topical oxygen therapy (TOT), and other modes of topical oxygen administration, which were compared with standard care group. Randomized and non-randomized studies were included. The primary outcome measure assessed was the rate of wound healing or wound closure.

RESULTS:
The review included 5 studies which used different modes of topical oxygen administration. The healing trajectory of the wounds was completely achieved in low-grade ulcers (grade 1), whereas all high-grade ulcers (grades 2, 3, and above) showed either 100% or 50% healing with a reduction in ulcer size and ulcer tissue depth.

CONCLUSION:
Topical oxygen therapy facilitates wound healing dynamics among individuals with chronic diabetic foot ulcers.
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NewsBot · Mar 18, 2020

Topical Oxygen Therapy Shifts Microbiome Dynamics in Chronic Diabetic Foot Ulcers.
Hunter P et al
Wounds. 2020 Mar;32(3):81-85.

INTRODUCTION:
Bacterial biofilm in wounds prevents healing by acting as a physical barrier to wound closure and hyperactivating local inflammatory processes, thus making its removal a high priority. The authors previously have shown that adding topical oxygen to standard wound care increased healing of Texas Grade II and III diabetic foot ulcers (DFUs), which they hypothesized was a result of alterations of the wound microbiome/biofilm.

OBJECTIVE:
This study aims to determine the mechanism of action of topical oxygen in DFUs by examining the diversity of bacterial genera present in DFUs treated with topical oxygen.

MATERIALS AND METHODS:
Six patients with chronic DFUs had their wounds swabbed weekly over an 8-week period of continuous topical oxygen treatment, and microbiome diversity was assessed by metagenomic 16S rDNA sequencing using a next-generation sequencing platform.

RESULTS:
The wound microbiome shifted toward a diverse flora dominated by aerobes and facultative anaerobes with oxygen therapy in 5 healed wounds. In contrast, anaerobic flora persisted in a single nonhealing ulcer in the present study cohort.

CONCLUSIONS:
Although the sample size was small, this study suggests topical oxygen therapy may have the ability to encourage the growth of aerobic members of the wound microbiome and be an effective alternative to antibiotics in this area.
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