Clinical Trial – Hyperbaric Oxygen Therapy in Patients With Chronic Stable Ischemic Heart Disease: An Option for Therapeutic Angiogenesis?

Hyperbaric oxygen therapy (HBOT) is proposed as a possible in vivo angiogenic stimulator for
improving microvascular myocardial perfusion and anginal symptoms as assessed by myocardial
perfusion imaging and angina questionnaire in patients with chronic stable ischemic heart
disease, when no other means to relief symptoms and/or ischemia are available.

Clinical Trial – Hyperbaric Oxygen Stimulation for Patients With Brain Malignancies After Radiation Therapy.

Radiotherapy is the mainstay of treatment for brain malignancies and is associated with
significant neurotoxicity. Due to continuous increase in patient’s survival, the long term
risk for radiation-induced brain inflammation and necrosis inducing secondary cognitive
impairments are increasing concerns. Currently there is no effective treatment for preventing
long term radiation-induced brain damage.

Hyperbaric oxygen therapy (HBOT) is the administration of high oxygen concentrations within a
pressurized chamber to increase the cellular/mitochondrial delivery of oxygen. Oxygen
stimulation by HBOT has become the definitive therapy for radiation-induced damage to soft
tissues and bone due to its ability to stimulate healing processes by supplying the
energy/oxygen needed while down-regulating genes involved in inflammation. Oxygen stimulation
by HBOT is currently indicated for patients with overt radiation-induced neurotoxicity and
was proven to reduce further development of radiation damage while stimulating "idling"
neurons to return to function. Since HBOT is considered safe, we hypothesize that its
application following radiation, before the manifestation of neurological side effects, may
help avert development of early/delayed onset radiation-induced neurotoxicity.

In the proposed study, for the first time, HBOT will be applied early after radiation to
prevent the expected decrease in patients neurocognitive functions (NCF) and improve their
quality of life (QOL). The study is designed to provide statistically significant assessment,
in a prospective randomized clinical trial, of the effect of oxygen stimulation applied soon
after brain radiotherapy, for patients with primary and secondary brain tumors, on patients
QOL and NCF. In addition, advanced imaging methodologies will be applied to study the
feasibility of quantifying oxygen stimulation effects on the tumor and surrounding brain
tissue.

Clinical Trial – The Regeneration Effects of Derma-PACE Shockwave in Chronic Diabetic Ulcers

Management of chronic diabetic foot skin ulcers require multidisciplinary approaches
including diabetic control, wound care, antibiotic, shoe wear off-loading, and surgery in
selected cases. The results are inconsistent and irregular, and most studies reported
unsatisfactory results. Many adjunctive therapies are implemented in the care of chronic
diabetic foot ulcers including hyperbaric oxygen therapy (HBO), ultrasound, recombinant human
platelet-derived growth factor-BB (rPDGF-BB), vacuum assisted wound closure (VAWC) and
acellular matrix. HBO is the most commonly utilized at the investigators institution. Mixed
results of HBO in chronic diabetic foot ulcers are reported. Several studies reported that
the beneficial effects of HBO, but none showed universal success. Therefore, the development
of a new effective method of treatment for chronic diabetic ulcers is extremely valuable.
Extracorporeal shockwave therapy (ESWT) acts as mechanotransduction that produces the
therapeutic benefits through complex biological pathways including neovascularization and
tissue regeneration. ESWT also showed bacteriostatic effects in experiments. Some studies
reported the effectiveness of ESWT in acute and chronic soft tissue wounds. Others reported
effectiveness of ESWT in chronic ulcers with 50% completely healed with 6 sessions of
treatment. With this background, it appears that ESWT may be effective in the treatment of
chronic diabetic foot ulcers. The purpose of this study is to evaluate the efficacy of ESWT
in chronic foot ulcers, and to compared with that treated with HBO, and to study the
molecular and blood flow perfusion before and after ESWT.