Hyperbaric Oxygen Therapy Facilitates Healing of Chronic Foot Ulcers in Patients With Diabetes

Löndahl, Magnus; Katzman, Per; Nilsson, Anders; Hammarlund, Christer

doi:10.2337/dc09-1754

Cited by 354 publications

(438 citation statements)

References 23 publications

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“…One study included 16 patients (8 patients per arm), and the other analyzed data from 94 patients (49 in HBOT and 45 in sham) (12). Both studies reported beneficial effects on healing but no reduction in amputation rates.…”

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confidence: 99%

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Hyperbaric Oxygen Therapy Does Not Reduce Indications for Amputation in Patients With Diabetes With Nonhealing Ulcers of the Lower Limb: A Prospective, Double-Blind, Randomized Controlled Clinical Trial

et al. 2016

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OBJECTIVEHyperbaric oxygen therapy (HBOT) is used for the treatment of chronic diabetic foot ulcers (DFUs). The controlled evidence for the efficacy of this treatment is limited. The goal of this study was to assess the efficacy of HBOT in reducing the need for major amputation and improving wound healing in patients with diabetes and chronic DFUs. RESEARCH DESIGN AND METHODSPatients with diabetes and foot lesions (Wagner grade 2-4) of at least 4 weeks' duration participated in this study. In addition to comprehensive wound care, participants were randomly assigned to receive 30 daily sessions of 90 min of HBOT (breathing oxygen at 244 kPa) or sham (breathing air at 125 kPa). Patients, physicians, and researchers were blinded to group assignment. At 12 weeks postrandomization, the primary outcome was freedom from meeting the criteria for amputation as assessed by a vascular surgeon. Secondary outcomes were measures of wound healing. RESULTSOne hundred fifty-seven patients were assessed for eligibility, with 107 randomly assigned and 103 available for end point adjudication. Criteria for major amputation were met in 13 of 54 patients in the sham group and 11 of 49 in the HBOT group (odds ratio 0.91 [95% CI 0.37, 2.28], P = 0.846). Twelve (22%) patients in the sham group and 10 (20%) in the HBOT group were healed (0.90 [0.35, 2.31], P = 0.823). All other indices of wound healing were also not statistically significantly different between groups. CONCLUSIONSHBOT does not offer an additional advantage to comprehensive wound care in reducing the indication for amputation or facilitating wound healing in patients with chronic DFUs.

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confidence: 99%

“…Two double-blind placebo controlled trials have been reported (11,12). One study included 16 patients (8 patients per arm), and the other analyzed data from 94 patients (49 in HBOT and 45 in sham) (12).…”

mentioning

confidence: 99%

Hyperbaric Oxygen Therapy Does Not Reduce Indications for Amputation in Patients With Diabetes With Nonhealing Ulcers of the Lower Limb: A Prospective, Double-Blind, Randomized Controlled Clinical Trial

et al. 2016

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“…48 Second, platelet-derived growth factor receptor appearance is also induced. [55][56][57] Third, a persistent increase in nitric oxide in wound fluid was demonstrated in wound fluid of diabetic ulcers that was associated with increased granulation tissue formation and wound closure in patients receiving HBO therapy. 58 Finally, increased release of stem, or progenitor, cells from bone marrow through a nitric oxide-dependent mechanism was also demonstrated in patients receiving HBO therapy.…”

Section: Correction Of Hypoxia (Role Of Hyperbaric Oxygenation Of Woumentioning

confidence: 99%

“…54 L€ ondahl et al showed complete healing in 52% of patients in an HBO group, compared with 29% with placebo. 55 Multiple consensus statements recommend HBO therapy as a reasonable modality to salvage diabetic limbs. In April 1999, the Consensus Development Conference on Diabetic Foot Wound Care sponsored by the American Diabetes Association 56 concluded that ''it is reasonable to use this modality [HBO] to treat severe and limb or life threatening wounds that have not responded to other treatments, particularly if ischemia that cannot be corrected by vascular procedures is present.''…”

Section: Correction Of Hypoxia (Role Of Hyperbaric Oxygenation Of Woumentioning

confidence: 99%

“…[35][36][37][38] Originally, the technique was 29,30,53,55,56,69,76 developed for use in neonatology, 39 but it is now commonly used in pediatric intensive care units, 40 plastic surgery, 41 vascular surgery, 42 anesthesiology, 43 orthopedics, 44 and hyperbaric medicine. 45 Tissue oxygenation and perfusion data are collected to identify the presence of tissue hypoxia, responders to hyperoxia, and adequacy of perfusion.…”

Section: Measurement Of Wound Hypoxiamentioning

confidence: 99%

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Correction of Hypoxia, a Critical Element for Wound Bed Preparation Guidelines: TIMEO2 Principle of Wound Bed Preparation

Shah

2011

The Journal of the American College of Certified Wound Speciali

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Wound bed preparation is an organized approach to create an optimal environment for wound healing by the use of the most cost-effective therapeutic options. It has become an essential part of wound management and seeks to use the latest findings from molecular and cellular research to maximize the benefits of today's advanced wound care products. The international advisory panel on wound bed preparation met in 2002 to develop a systemic approach to wound management. These principles of this approach are referred to by the mnemonic TIME, which stands for the management of nonviable or deficient tissue (T), infection or inflammation (I), prolonged moisture imbalance (M), and nonadvancing or undermined epidermal edge (E). One critical element of pathophysiology, understanding of the hypoxic nature of the wound and correction of hypoxia as a critical element of wound bed preparation, is not covered. This article proposes to add correction of hypoxia to the TIME principle (TIMEO 2 principle) based on the evidence. The evidence that will support the reason and the need for modification of the wound bed preparation protocol is discussed.

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Diabetic Foot Ulcers

Armstrong

Tan

Boulton

et al. 2023

JAMA

295

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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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Hyperbaric Oxygen Therapy Facilitates Healing of Chronic Foot Ulcers in Patients With Diabetes

Cited by 354 publications

References 23 publications

Hyperbaric Oxygen Therapy Does Not Reduce Indications for Amputation in Patients With Diabetes With Nonhealing Ulcers of the Lower Limb: A Prospective, Double-Blind, Randomized Controlled Clinical Trial

Hyperbaric Oxygen Therapy Does Not Reduce Indications for Amputation in Patients With Diabetes With Nonhealing Ulcers of the Lower Limb: A Prospective, Double-Blind, Randomized Controlled Clinical Trial

Correction of Hypoxia, a Critical Element for Wound Bed Preparation Guidelines: TIMEO2 Principle of Wound Bed Preparation

Diabetic Foot Ulcers

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