Clinical Trials

Clinical Trial – Hyperbaric Oxygen and Its Effect on Radiation Induced Long Term Side Effects

The investigators intend to determine if patients that are already undergoing Hyperbaric
Oxygen (HBO) therapy one year post treatment with radiation therapy for head and neck cancer,
experience improvement in xerostomia and/or taste alteration. The investigators will enroll a
similar demographic one year post treatment with radiation therapy that does not receive HBO
therapy. This is a quality of life study.

Clinical Trial – Intrathecal Ketamine, Dexmedetomidine and Both With Bupivacaine for Postoperative Abdominal Cancer Surgery Pain

Currently, opioids are widely used for pain relief, but they often provide sub-optimal
analgesia with occasional serious side effects. Preservative-free ketamine hydrochloride was
introduced as a spinal anesthetic more than twenty years ago and found to have advantages
over local anesthetics. Intrathecal dexmedetomidine provides an analgesic effect in
postoperative pain without severe sedation. The objectives of this study were to compare the
efficacy and safety of intrathecally administered dexmedetomidine, ketamine, or their
combination when added to bupivacaine for postoperative analgesia in major abdominal cancer
surgery.

Clinical Trial – HBOT Late Radiation Tissue Injury

Background: Radiotherapy is a common treatment for many malignancies. Radiation-related
complications developing months or years after radiation treatment are known as late
radiation tissue injury (LRTI) and are estimated to effect 5%-15% of all long-term survivors
who have received radiation.

Hyperbaric oxygen therapy (HBOT) is a well established treatment of LRTI. Most of the studies
evaluating effect of HBOT on LRTI are focused on survival, resolution of tissue damage and
improvement in LENT-SOMA scale. Very few studies have addressed effect of HBOT on pain in
LTRI. Krahn and colleagues were the first to report the analgesic effect of HBOT in 3 cases
of refractory pain in oncological patients with radiation soft tissue injury. Other studies
showed significant improvement in pain intensity in patients with breast cancer and pelvic
malignancies treated with HBOT for LTRI. In patients that had developed radiation- induced
brachial plexopathy, HBOT elicited an increase in warm pain thresholds and a reduction in
lymphoedema. A prospective case study of 16 patients with gynecological cancer found no
changes with respect to pain and depression outcomes. A trial in patients with radiation
induced proctopathy showed that 75% of patients with rectal pain had some improvement,
although none experienced a complete resolution of pain symptoms.

There are several mechanisms by which HBOT may elicit analgesic effects. There is a growing
body of evidence that HBOT’s analgesic effect related to nitric oxide metabolism and
endogenous opioid secretion. Furthermore, the inhibition of tumor necrosis factor alph
(TNF-α), the production of substance P, and the modulation of serotonergic pathways have all
demonstrated a modification in the pain response following HBOT. In animal studies HBOT
decreased allodynia and hyperalgesia in different models of neuropathic and inflammatory
pain. The long lasting antinociceptive effect of HBOT was found to be dose-dependent in
non-injured tissues.

In human studies, HBOT decreased pain and edema and improved function in patients suffering
from the complex regional pain syndrome, and improved pain scores and range of motion in
patients with idiopathic femoral head necrosis. Women suffering from interstitial cystitis
demonstrated a reduction in pelvic pain following weeks and months of HBOT treatment. In
patients suffering from idiopathic trigeminal neuralgia HBOT produced a rapid reduction in
symptoms and these effects were lasting for 6 months following treatment. HBOT was also found
to be an effective treatment for cluster headaches and migraines and alleviated muscle and
bone pains in patients with myofascial syndrome, fibromyalgia, and biphosphonate-related
osteonecrosis of the jaw.

Based on the evidence presented above and HBOT’s known analgesic effect in many conditions,
the investigators designed this study with the objective to evaluate if HBOT reduces pain,
improves depression and impacts on patients quality of life in patients suffering from late
radiation tissue injury.

Study Design: Prospective observational study (n=300). Patients that have had radiation
therapy for malignancy, developed late radiation injury and suffer from chronic pain.

Clinical Trial – HBOT in Fibromyalgia

Fibromyalgia (FM) is a chronic pain condition affecting several millions of Canadians.
Although the etiology and pathophysiology are poorly understood, there is a well-recognized
association between muscular pain in fibromyalgia and muscular hypoperfusion, hypoxia,
abnormal muscle metabolism and oxidative stress. Currently there is no cure for FM.
Pharmacological and non-pharmacological strategies are directed to control symptoms such as
pain, fatigue, non-restorative sleep and depression.

Hyperbaric oxygen therapy (HBOT) is an intermittent inhalation of 100% oxygen in a hyperbaric
chamber at a pressure higher than 1 absolute atmosphere. Physiological effect of HBOT is
based on a dramatic increase in the amount of dissolved oxygen carried by the blood which
enables oxygenation of ischemic areas with compromised circulation. It also activates
oxidant-antioxidant system, stimulates angio- and neurogenesis, modulates inflammatory
response, induces brain neuroplasticity and possesses analgesic effect.

While some interventions offer benefit for some patients, additional treatment alternatives
are needed for patients with FM in whom currently available options are either ineffective or
poorly tolerated. Given its physiological effect, HBOT could be considered as a potential
therapy for treatment of underlying muscular hypoxia, optimizing oxidant- antioxidant system
and controlling FM symptoms. The results from this study could therefore provide new
information supporting the basic science underling the pathophysiology of this disease and
stimulate novel therapies for patients suffering with FM.

Clinical Trial – MRI Brain Changes Induced by Hyperbaric Oxygen Therapy in Brain Injury Patients

In our institute there is ongoing treatment of brain injury patients with Hyperbaric oxygen
therapy. These patients undergo neuro-cognitive function tests in addition to brain imaging
studies before and after treatment.

The aim of this study was to evaluate the perfusion and microstructure changes seen in MRI in
addition to the cognitive tests before and after the treatment.

Clinical Trial – Evaluation of Result and Influence Factors on Composite Graft in Fingertip Amputation

Fingertips facilitate smooth motor activity, precise sensation, and the delicate movement of
the hands and have an aesthetic function. Fingertip injuries are defined as injuries
occurring distal to the insertion of the flexor and extensor tendons. These injuries are one
of the most common trauma injuries presented in acute care settings, accounting for
approximately 4.8 million emergency department visits per year in the United States.(1)
Fingertip amputations may not constitute the majority among these fingertip injuries but can
have a complex spectrum of injury. In these cases, the reconstruction methodologies focus on
preserving the digital length, ensuring adequate soft tissue coverage, preserving the nail
structure, achieving a well-contoured and painless fingertip, and restoring durable and
sensate skin.

There are so many factor that influence the result of composite graft in distal finger tip
amputation. Investigators will collected the data including the size of amputee , shape,
level of amputation, mechanism of amputation, if hyperbaric oxygen therapy, operation
procedures.

Clinical Trial – Efficacy of the Combination of Isosorbide Dinitrate Spray and Chitosan in Diabetic Foot Ulcers

The prevalence of diabetic foot ulceration in the diabetic population is 4-10%; the condition
is more frequent in elder patients. It is estimated that about 5% of all patients with
diabetes present a history of foot ulceration, while the lifetime risk of diabetic patients
developing this complication is 15%. The majority (60-80%) of foot ulcers will heal, while
10-15% of them will remain active, and 5-24% of them will finally lead to limb amputation
within a period of 6-18 months after the first evaluation , 2 out of 3 patients with a limb
amputation could also be involved in a new amputation in the next year; higher or in the
other leg , Eighty-five percent of lower-limb amputations in patients with diabetes are
preceded by foot ulceration. The management of chronic diabetic foot ulcers (DFU) suggests
multi-disciplinary approaches including control of diabetes, orthotic shoe wear, off-loading
device, wound care and surgery in selected cases. However, treatment of DFU remains
challenging because of unsatisfactory results from surgical and non-surgical treatments. Many
adjunctive therapies are designed to improve the care of DFU including negative pressure
wound therapy , ultrasound, recombinant human platelet-derived growth factor-BB (rPDGF-BB)
Hyperbaric oxygen and acellular matrix product among others.

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