Diabetes

Clinical Trial – Hyperbaric Oxygen Therapy and Angiogenesis in Diabetic Patients With Foot Ulcers

Diabetic foot ulcers are a major cause of morbidity and mortality, accounting for
approximately two-thirds of all non-traumatic amputations performed in the United States. The
cost of foot ulcers in diabetic patients averages almost $28,000 for the two years after
diagnosis of the ulcer. Hyperbaric oxygen (HBO) serves as primary or adjunctive therapy for a
diverse range of medical conditions. HBO also has been used as an adjunct to antibiotics,
debridement, and revascularization in the therapy of chronic, nonhealing wounds associated
with diabetes or non-diabetic vascular insufficiency.

The aim of the study is to assess whether hyperoxia induced angiogenesis in diabetic patients
with foot ulcers.

Clinical Trial – Hyperbaric Oxygen, Oxidative Stress, NO Bioavailability and Tissue Oxygenation

Hyperbaric oxygen therapy (HBOT) increases tissue oxygenation and serves as an adjunct
therapy for diabetic wounds. However, some patients have insufficient increase or even
paradoxical decrease in tissue O2 due to vasoconstriction. The aim of the present study was
to investigate the pathophysiology responsible for the different consequences of HBOT and to
evaluate the effect of N-acetylcysteine (NAC) on these changes.

Methods: Prospective, randomized, cross-over trial including fifty diabetic patients with
non-healing ulcers. All patients had two HBOT (100%oxygen, 2ATA) with NAC at the first or the
second evaluation. At the beginning and at the end of each evaluation, ulcer oxygenation and
plasma levels of malondialdehyde (MDA), total anti-oxidant status (TAOS) and nitric oxide
(NO) were measured. Patients with ulcer oxygenation above 200mmHg, were subjected to complete
HBOT protocol.

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