Healthcare Professionals

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Healthcare Professionals

Healthcare Professionals

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Healthcare Professionals

Clinical Evidence

Clinical Bibliography

2017 Conference Abstracts

“The use of combined modulated ultrasound and electric field stimulation for chronic wound healing”, Dr. Tom O’Connor RGN RNT Dip Nur, BSc, MSc Ad Nursing, PG Dip Ed, EdD

“Combined Ultrasound and Electric Field Stimulation cause an immediate wound healing response in chronic wounds”, Jonathan Rosenblum, DPM

“The Israeli Experience with Combined Ultrasound and Electric Field Stimulation on Chronic Wounds”, Jonathan Rosenblum, DPM

“A novel therapy of combining ultrasound and electrical field stimulation as an adjuvant treatment for recalcitrant venous leg ulcers”, Diane Eng, 2nd Place Oral Abstract award

“The Israeli, Australian and Italian Experience”, Jonathan Rosenblum, DPM

“An evaluation of the use of combined ultrasound and electrostimulation for chronic diabetic foot ulcers”, Dr. Tom O’Connor RGN RNT Dip Nur, BSc, MSc Ad Nursing, PG Dip Ed, EdD

Clinical Publications

The Science of BRH

BRH-A2 device uses Interferential Therapy (IFT) to initiate “micro-circulation” of the affected area. This results in a massage-like activity within the tissues and blood vessels of the impacted medium, increasing the blood flow for increasing the healing rate significantly.

The IFT technology is a modulated combination of therapeutic ultrasound and low frequency electrostimulation designed to reduce muscle spasm, increase extensibility of collagen fibers and create a pro‐inflammatory response.

IFT uses the significant physiological effects of low frequency electrical stimulation of nerves without the associated painful and somewhat unpleasant side effects sometimes associated with low frequency stimulation.

Side effects of low frequency at sufficient intensity and at sufficient depth include considerable discomfort on the skin due to the impedance of the skin being inversely proportional to the frequency of the stimulation. The result of applying a higher frequency is that it will pass more easily through the skin, requiring less electrical energy input to reach the deeper tissues & giving rise to less discomfort.

In this configuration, a much lower voltage signal can be used to produce the desired current, resulting in less skin sensation and a more comfortable treatment.

Clinical Effects of IFT Wound Healing Technology

The BRH device works by combining ultrasound and electrostimulation technologies that are modulated repeatedly during the treatment. The result being that during the length of the treatment the patient is receiving varying types and intensities of both electrostimulation and ultrasound.

The changes are programmed into the treatment protocol and the maximum intensities are measured by sensors during the treatment. What this means from a physiological point of view is that during the treatment period, the tissues are being affected by various submodalities. These combinations affect the cells differently and thus maximize the efficacy of both treatment modalities.

One of the main physiological benefits of this combination is pain modulation. Both modalities are known pain relievers. However by initiating electric field stimulation the BRH device is able to give more ultrasound energy to help with pain management. This combination is more than the sum of the parts because one modality allows for more and more efficacious delivery of the second.

Another physiological effect is fibroblast stimulation and collagen synthesis. Ultrasound is a known fibroblast stimulant causing more and better ordered collagen synthesis. Electric Field stimulation is known to pull taut the newly seeded collagen. The result is a cleaner more ordered tighter healed wound. This is most important in prevention of wound recurrence. By having what is essentially new tissue and not scar tissue in the healed wound, the risk of recurrence is greatly reduced.

Economics of Wound Care

Around the world the numbers of people suffering from diabetes continues to increase. Inherent qualities of diabetes leads to reduced blood circulation in the extremities. This phenomena leads to increased propensity to suffer from chronic wounds.

Diabetic ulcers are the most common cause of foot and leg amputation.

Facts (according to the American Diabetes Association)

25% of diabetic individuals will develop chronic ulcers throughout their life. Approximately 14-24% of these individual's condition will lead to amputation.
Over 9-12 Million of the U.S. adult population suffers from chronic ulceration each year which costs the healthcare system 28$ Billion annually.
Among chronic wounds the highest prevalence lays in the venous leg ulcer (VLU), diabetic foot/leg wound (DFU) and pressure ulcer (PU) categories. Estimates of annual VLU incidence in the US reach nearly 1 million people.
Treatment costs for individual venous ulcerations have been reported to range between $957.99 to $1352.00 per ulcer, with higher costs for the treatment of stalled ulcers ($9,685.00).
Expenses are not limited solely to the cost of ulcer care, but include other indirect costs associated with disability and lost work days. In addition to the effects of chronic ulceration, the condition can frequently result in lower extremity amputations, disabling and very frequently risking lives.
30–50% of amputees will undergo an additional amputation within 1-3 yrs.
The mortality rate within 3 years after the first lower extremity amputation ranges from 20 to 50%, while the 5-year mortality rate is reported to be as high as 70%

UK

In 2010-11, the NHS in England spent an estimated £639 million–£662 million, 0.6– 0.7% of its budget on diabetic foot ulceration and amputation.
Patients with type I or II diabetes have a 1-4% annual chance of foot ulceration and a lifetime risk that may be as high as 25%.
Estimates for the UK indicate that 15% of all diabetes patients develop DFUs and that 84% of lower leg amputations are caused by DFUs
A recent study in the UK showed a prevalence of patients with a wound was 3.55 per 1000 population. The majority of wounds were surgical/trauma (48%), leg/foot (28%) and pressure ulcers (21%).
Prevalence of wounds among hospital inpatients was 30.7%.
There are in excess of 100,000 active venous ulcers in the UK at any one time.
Leg ulcers consume 60% of district nurse time and 44% of their budget.
The cost of “keeping an ulcer going” is estimated to be between £2,500 and £5,000 per annum.
Considerable resources are wasted in maintaining rather than healing ulcers.
80% of leg ulcers are treated in the community.

Wounds and dressings will perpetually appear near the top of the cost list in the regular PACT figures for virtually all GPs.
Wounds in Australia are highly significant health issue: some estimates suggest that over 200,000 Australians have problem wounds at any one time.
Approximately 60-70% of all leg ulcers originate from venous disease and occurrence is expected to rise as the population ages.
Twenty to 50% of these patients will have amputation of the remaining (contralateral) leg in 1–3 years, and 50% will require amputation in 5 years.
Chronic wounds, including venous ulcers, diabetic foot ulcers, and pressure sores, are a significant health problem in the United States, affecting approximately 1% of adults

The BRH Difference

The BRH device needs to be differentiated from other devices which claim to be at least parts of their treatment. First on the Ultrasound side, the modulation of the intensities and frequencies is unique. Second the Electric stimulation while varying during the treatment is all concentrated on the surface. It is not to be confused with TENS or EMS which penetrate across the skin. The idea behind the BRH EFS is to create a superficial electric field restoring the skins natural electric current. By doing this the cells can be altered and be affected differently.

The combination of these two technologies as well as their unique presentations allow for a truly unique device. The result is a quicker healing wound with fewer complications, less pain and significantly less recurrence.

The combination of low frequency ultrasound and modulated electrostimulation affect wound healing by removing the barriers to healing as well as stimulating the production of collagen to promote new cell growth.

FAQs

What types of wounds can benefit from this treatment?

Diabetic Foot Ulcers, Venous Leg Ulcers, Ischemic Ulcers, and Pressure Ulcers

Is there a size limit for the wounds treated with your method?

We have not seen any wound which cannot be treated.

Is the BRH Wound Healing System clinically proven?

The BRH System is clinically proven in several clinical settings. Three publications have been published in peer-reviewed journals.

What types of changes will I expect to see?

Changes in skin color and tissue appearance both within the wound and in the tissue around the wound.

Having seen the articles explaining the effects of ultrasound or electric stimulation alone on wound care, how does the combination of the modalities affect healing?

The protocol implemented by the BRH system heightens the physical effects of each modality by the unique combination. First, the effect of the electric fields changes the cellular and interstitial profile enabling enhanced penetration and effect of the ultrasound wave. Because of the altered cellular status, the effect of the acoustic wave is heightened. The centralization of the acoustic wave expands circumferentially through the tissues changing the character of the tissues and on an electric field this changes the impedance. The varying electric fields generated by the BRH system accounts for this variation and accommodates itself within its program to enable a consistent electrical field in the skin. The ultrasound causes a release of and a migration of various sets of cells and intermediaries that are important for wound closure. The changing direction of the electric field helps to spread these beneficial cells across the wound area.

Does the BRH system kill bacteria?

The BRH system is relatively bacteriostatic, and it is especially effective in treating biofilm. The direct mechanical effect on the polysaccharide structure as well as the interference with the bacteria’s quorum sensing is highly effective in returning the bacteria to their planktonic form where they are further susceptible to the mechanical as well as traditional treatments. In addition, the combined effect aids this destruction to penetrate deeper into the tissue, killing the bacteria that often recolonize a cleansed wound.

Are there any benefits to using the BRH System in addition to healing the wound?

Yes. From our extensive experience treating hundreds of wounds, we have seen that pain is reduced significantly usually by the 3rd or 4th treatment. We have also seen that periwound tissue quality is improved as neoangiogenesis occurs not only in the wound but around it. Localized edema is also slightly reduced.

What is the standard protocol and how was this determined?

The protocol has been determined after hundreds of treatments. Originally, we determined the treatment time at 30 minutes. However, once we gathered enough clinical data, we reevaluated the correlation between the program cycle and the resulting effect of the tissue and we ascertained that same effects could be achieved in 15 minutes.

Do patients get healed completely after all? Does the treatment help if this is a recurring wound?

Some of the patients healed completely. Study results showing accelerated initial tissue regrowth in more than 50% of the cases within 30 days of treatment. We have also seen significant reduction in pain, sometimes after the first treatment.

Can the BRH treatment be used with other treatments?

Yes. The BRH is part of a complete healing plan, and is another tool to improve your success in treating hard-to-heal chronic wounds.

When will I start to see improvement?

This is variable per patient. From most physicians experience with the BRH some change will be felt or seen within the first two weeks of treatment.

During the healing process, is there any contributory treatments for the patients? Like drugs or ointments?

We cannot recommend parallel or adjunctive treatments. Decisions regarding additional treatment modalities in parallel are the sole decision of the treating physician.

What equipment will I need to perform a treatment?

We provide sets of disposables together with the device. Each patient requires a new set of disposables consisting of: sterile covers for the ultrasound transducer and cable, and a set of electrodes.

Do I have to perform the treatment by myself?

No. The BRH treatment can be performed by any trained operator. (The operator does not need to be medically trained)

Is the system difficult to operate?

The system is intuitive with very simple software operation. The training process is straightforward.

Do we need any kind of gel or solution for improved conductivity? Or is it just a regular ultrasound gel?

Regular gel.

Are there any contraindications?