Efficacy of Topical Wound Oxygen Therapy in Healing Chronic Diabetic Foot Ulcers: Systematic Review and Meta-Analysis

Carter, Marissa J.; Frykberg, Robert G.; Oropallo, Alisha; Sen, Chandan K.; Armstrong, David G.; Nair, Harikrishna K.R.; Serena, Thomas E

doi:10.1089/wound.2022.0041

Cited by 22 publications

(35 citation statements)

References 32 publications

(26 reference statements)

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“…Hyperbaric oxygen therapy may be an adjunctive therapy in diabetic foot ulcers with concomitant peripheral artery disease when standard of care alone has not attained healing, based on the results of several randomized clinical trials that are not consistent in their outcomes . Topical oxygen as an adjunct therapy in diabetic foot ulcers may be considered when standard of care alone has failed (<50% of ulcer healed at 4 weeks), based on recent meta-analyses of randomized clinical trials and systematic reviews . Pooled results from the most recent meta-analysis showed improved healing with topical oxygen therapy over sham controls (43.0% vs 28.0%; RR, 1.59; 95% CI, 1.07-2.37; P = .02) …”

Section: Managementmentioning

confidence: 99%

“…Topical oxygen as an adjunct therapy in diabetic foot ulcers may be considered when standard of care alone has failed (<50% of ulcer healed at 4 weeks), based on recent meta-analyses of randomized clinical trials and systematic reviews . Pooled results from the most recent meta-analysis showed improved healing with topical oxygen therapy over sham controls (43.0% vs 28.0%; RR, 1.59; 95% CI, 1.07-2.37; P = .02) …”

Section: Managementmentioning

confidence: 99%

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Diabetic Foot Ulcers

Armstrong

Tan

Boulton

et al. 2023

JAMA

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206

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ImportanceApproximately 18.6 million people worldwide are affected by a diabetic foot ulcer each year, including 1.6 million people in the United States. These ulcers precede 80% of lower extremity amputations among people diagnosed with diabetes and are associated with an increased risk of death.ObservationsNeurological, vascular, and biomechanical factors contribute to diabetic foot ulceration. Approximately 50% to 60% of ulcers become infected, and about 20% of moderate to severe infections lead to lower extremity amputations. The 5-year mortality rate for individuals with a diabetic foot ulcer is approximately 30%, exceeding 70% for those with a major amputation. The mortality rate for people with diabetic foot ulcers is 231 deaths per 1000 person-years, compared with 182 deaths per 1000 person-years in people with diabetes without foot ulcers. People who are Black, Hispanic, or Native American and people with low socioeconomic status have higher rates of diabetic foot ulcer and subsequent amputation compared with White people. Classifying ulcers based on the degree of tissue loss, ischemia, and infection can help identify risk of limb-threatening disease. Several interventions reduce risk of ulcers compared with usual care, such as pressure-relieving footwear (13.3% vs 25.4%; relative risk, 0.49; 95% CI, 0.28-0.84), foot skin measurements with off-loading when hot spots (ie, greater than 2 °C difference between the affected foot and the unaffected foot) are found (18.7% vs 30.8%; relative risk, 0.51; 95% CI, 0.31-0.84), and treatment of preulcer signs. Surgical debridement, reducing pressure from weight bearing on the ulcer, and treating lower extremity ischemia and foot infection are first-line therapies for diabetic foot ulcers. Randomized clinical trials support treatments to accelerate wound healing and culture-directed oral antibiotics for localized osteomyelitis. Multidisciplinary care, typically consisting of podiatrists, infectious disease specialists, and vascular surgeons, in close collaboration with primary care clinicians, is associated with lower major amputation rates relative to usual care (3.2% vs 4.4%; odds ratio, 0.40; 95% CI, 0.32-0.51). Approximately 30% to 40% of diabetic foot ulcers heal at 12 weeks, and recurrence after healing is estimated to be 42% at 1 year and 65% at 5 years.Conclusions and RelevanceDiabetic foot ulcers affect approximately 18.6 million people worldwide each year and are associated with increased rates of amputation and death. Surgical debridement, reducing pressure from weight bearing, treating lower extremity ischemia and foot infection, and early referral for multidisciplinary care are first-line therapies for diabetic foot ulcers.

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Section: Managementmentioning

confidence: 99%

Section: Managementmentioning

confidence: 99%

Diabetic Foot Ulcers

Armstrong

Tan

Boulton

et al. 2023

JAMA

Self Cite

206

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“…There have been a number of developments in the treatment of ulcerations over the years (90). These include negative-pressure therapy, growth factors, bioengineered tissue, acellular matrix tissue, stem cell therapy, hyperbaric oxygen therapy, and, most recently, topical oxygen therapy (91)(92)(93). While there is literature to support many modalities currently used to treat diabetic foot wounds, robust randomized controlled trials (RCTs) are often lacking.…”

Section: Treatmentmentioning

confidence: 99%

“…Topical oxygen therapy has been studied rather vigorously in recent years, with several high-quality RCTs and at least five systematic reviews and metaanalyses all supporting its efficacy in healing chronic DFUs at 12 weeks (19,20,(30)(31)(32)(33)(34)91,92,(101)(102)(103)(104)(105). Three types of topical oxygen devices are available, including continuous-delivery, low-constant-pressure, and cyclicalpressure modalities.…”

Section: Treatmentmentioning

confidence: 99%

12. Retinopathy, Neuropathy, and Foot Care:Standards of Care in Diabetes—2023

ElSayed¹,

Aleppo²,

Aroda³

et al. 2022

Diabetes Care

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The American Diabetes Association (ADA) “Standards of Care in Diabetes” includes the ADA’s current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, a multidisciplinary expert committee, are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA’s clinical practice recommendations and a full list of Professional Practice Committee members, please refer to Introduction and Methodology. Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.

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“…The metabolic imbalance occurring in diabetic patients, in conjunction with diabetes-associated vascular conditions, causes a delayed and impaired healing process in skin injuries, generally resulting in chronic and complicated wounds [ 72 , 73 ]. As they undergo hypoxia, which alters the healing process through immune and cellular events, the fabrication of oxygen-releasing platforms emerges as a promising strategy for the local management of diabetic wounds [ 74 , 75 ]. Therefore, to improve the restorative potential of the herein-proposed hydrogels, oxygen-entrapping PLA microspheres were fabricated and incorporated into the base materials.…”

Section: Discussionmentioning

confidence: 99%

H2O2-PLA-(Alg)2Ca Hydrogel Enriched in Matrigel® Promotes Diabetic Wound Healing

et al. 2023

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Hydrogel-based dressings exhibit suitable features for successful wound healing, including flexibility, high water-vapor permeability and moisture retention, and exudate absorption capacity. Moreover, enriching the hydrogel matrix with additional therapeutic components has the potential to generate synergistic results. Thus, the present study centered on diabetic wound healing using a Matrigel-enriched alginate hydrogel embedded with polylactic acid (PLA) microspheres containing hydrogen peroxide (H2O2). The synthesis and physicochemical characterization of the samples, performed to evidence their compositional and microstructural features, swelling, and oxygen-entrapping capacity, were reported. For investigating the three-fold goal of the designed dressings (i.e., releasing oxygen at the wound site and maintaining a moist environment for faster healing, ensuring the absorption of a significant amount of exudate, and providing biocompatibility), in vivo biological tests on wounds of diabetic mice were approached. Evaluating multiple aspects during the healing process, the obtained composite material proved its efficiency for wound dressing applications by accelerating wound healing and promoting angiogenesis in diabetic skin injuries.

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Efficacy of Topical Wound Oxygen Therapy in Healing Chronic Diabetic Foot Ulcers: Systematic Review and Meta-Analysis

Cited by 22 publications

References 32 publications

Diabetic Foot Ulcers

Diabetic Foot Ulcers

12. Retinopathy, Neuropathy, and Foot Care:Standards of Care in Diabetes—2023

H2O2-PLA-(Alg)2Ca Hydrogel Enriched in Matrigel® Promotes Diabetic Wound Healing

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