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.
Clinical Trials
Clinical Trial – Study Comparing a Nerve Block With Spinal Opiate to Provide Pain Relief for Hip Replacement Surgery
Pain control after hip replacement surgery is important to ensure patient comfort, allow
mobilisation, and aid recovery. The investigators propose a simple and pragmatic study
comparing two different anaesthetic techniques in the provision of pain relief after hip
surgery. Patients will be randomised to receive either spinal anaesthesia containing morphine
or spinal anaesthesia without morphine and an ultrasound guided fascia iliaca nerve block.
Although morphine is an effective pain killer, its side effects include itch, urinary
retention, nausea and potentially fatal breathing problems. If the nerve block can be shown
to provide comparable pain relief to spinal morphine, then morphine could be removed from the
spinal injection. This could reduce side effects and improve patient safety. The
investigators wish to investigate whether ultrasound guided fascia iliaca plane block
provides analgesia which is comparable to that of intrathecal opioid for primary hip
arthroplasty in the first 24 hours after hip replacement surgery
Clinical Trial – Hyperbaric Oxygen Therapy (HBO2T) for Post-Concussive Symptoms (PSC) After Mild Traumatic Brain Injury (mTBI)
The goal of this research is to serve as a demonstration project to determine the
tolerability of individuals with persistent post-concussive symptoms from combat-related mild
TBI (traumatic brain injury), identify dose-finding for HBO2 (Hyperbaric Oxygen) therapy, and
determine the efficacy of HBO2 therapy.
Clinical Trial – Intravenous Ondansetron to Attenuate the Hypotensive, Bradycardic Response to Spinal Anesthesia in Healthy Parturients
The investigators hypothesize that given prophylactically, intravenous ondansetron will
attenuate the drop in blood pressure and heart rate frequently seen after spinal anesthesia.
Eighty-six American Society of Anesthesiologists (ASA) physical status I or II in
preoperative patient assessment, parturients age of 18 to 45 years scheduled to undergo
elective caesarean section will be enrolled.
Patients will be randomized to 2 groups: the ondansetron group, receiving 8 mg intravenous
ondansetron diluted in 10 mL of saline; or the placebo group, who were administered 10 mL of
saline given 5 minutes prior to performing the spinal anesthetic. Investigational Pharmacy
will randomize and dispense study drug.
Baseline measurements of vital signs will be taken. Otherwise standard management will then
be used:
– Patients must be NPO for 8 hours
– Pulse oximetry, EKG monitoring, noninvasive blood pressure at a minimum of every 3
minutes, more frequently if decided by the provider.
– Standard lumbar puncture in a sitting position the L3-L4 or L4-L5
– Whitacre pencil-point, 25 gauge
– Injectate: 2 mL of 0.75% hyperbaric bupivacaine, 100 mcg preservative free morphine, 20
mcg fentanyl
– Immediately after completing the subarachnoid injection, patients will be laid supine
with left lateral uterine displacement
The sensory level of anesthesia will be assessed in the standard fashion every five minutes
using ice. The motor component will tested using the Bromage scale for spinal anesthesia (0,
no paralysis; 1, inability to lift the thigh [only knee/feet]; 2, inability to flex the knee
[only feet]; 3, inability to move any joint in the legs).
Clinical Trial – Comparison of Different Doses of Clonidine to Fentanyl as an Adjuvant to Bupivacaine 0.5% for Spinal Anesthesia
The purpose of this study is to evaluate the safety, quality and duration of block with the
addition of Clonidine in different doses to 0.5% heavy bupivacaine, and to compare it with
addition of Fentanyl to 0.5% heavy bupivacaine in sub- arachnoid block.
Clinical Trial – The Analgesic Effect of Intrathecal Hydromorphone Injection on Spinal Anesthesia
The purpose of this study is to evaluate the adequate dose of intrathecal hydromorphone
injection for postoperative pain relief after knee arthroscopic surgery.
Clinical Trial – Tissue Perfusion and Blood Flow Monitoring Technology
The purpose of this study is to investigate the safety and efficacy of an optical device
designed and developed to quantitatively monitor blood flow velocity of wound sites. The
hypothesis is that the blood flow velocity of the wound site will provide critical
information on the efficacy of hyperbaric oxygen therapy.
Clinical Trial – Hyperbaric Oxygen – a New Treatment Modality in Patients With Radiation Damaged Salivary Gland Tissue
Randomized clinical trial regarding the effect of hyperbaric oxygen on late radiation tissue
injury to salivary gland tissue.
Clinical Trial – Hyperbaric Oxygen Therapy in Chronic Traumatic Brain Injury or Post-Traumatic Stress Disorder
This is an observational research study whose purposes are to see:
1. if 40 Hyperbaric Oxygen Therapy sessions at 1.5 atmospheres (HBOT 1.5) or more (60, or
80 HBOT’s) help, worsen, or have no effect on subjects with chronic TBI/PCS (Traumatic
Brain Injury/Post-Concussion Syndrome) and/or PTSD (Post-Traumatic Stress Disorder).
2. if improvements or worsening of symptoms can be recorded with computerized and written
tests for memory and thinking, and with questionnaires about the subject’s quality of
life and health.
3. determine the long-term outcome of the treatment.
4. confirm, in large numbers of study participants at multiple sites nationwide, the strong
positive results obtained in pilot studies
Clinical Trial – Hyperbaric Oxygen Therapy for Comatose Patients With Acute Carbon Monoxide Poisoning
Carbon monoxide poisoning still places a burden on the healthcare system worldwide. While
oxygen therapy is the cornerstone treatment, the role and practical modalities of hyperbaric
oxygen therapy (HBO) remain controversial. This study aimed at comparing two sessions of HBO
at 2 absolute atmosphere and one session of HBO at 2 absolute atmosphere followed by 4 hours
of normobaric oxygen therapy in comatose adult victims of acute domestic carbon monoxide
poisoning.