Increasing Blood Flow Ultrasound and Electric Current fields (IBFUSEC) improves Clinical outcome of diabetic foot ulcers.

Transcription

1 BRH system Increasing Blood Flow Ultrasound and Electric Current fields (IBFUSEC) improves Clinical outcome of diabetic foot ulcers. Pilot clinical assessments performed by 4 doctors in 3 different countries: Yariv Malimovka MD MMC, Spain Moti Yair Levy MD Timisoara, Romania Drorit Attias MD Dr. Eyal Atias Clinics, Israel Eyal Attias MD Dr. Eyal Atias Clinics, Israel Research assistant: Tal Ben Ari W. 1

2 Abstract BRH system Increasing Blood Flow Ultrasound and Electric Current fields (IBFUSEC) improves Clinical outcome of diabetic foot ulcers. Background: Diabetic ulcers are the most common cause of foot and leg amputation. 25% of diabetic individuals will develop chronic ulcers throughout their life. Approximately 14-24% of these individual's condition will lead to amputation. The BRH system uses the combination of Low Intensity Ultrasound and Low Frequency Electric current fields. Thermal and non thermal physical effects (resonance) of the combination of US and ECF increases blood flow, reduces muscle spasm and increases extensibility of collagen fibers and a pro inflammatory response. Study: This Pilot clinical assessment has been performed in Spain, Romania and Israel. 21 patients with severe diabetic ulcers were included in this study. All patients were treated prior to affiliation for at least 6 months with systemic and local treatments such as debridement, antibiotics, hyperbaric oxygenation, vacuum systems and ozone therapy. During these months their wounds did not close. In the study, patients were treated, a one hour treatment, 1-4 times a week. Systemic and local ozone therapies were performed in conjunction with the study's treatments. Wounds parameters were photographed and measured by depth and surface area. Results: The wounds of all 21 patients closed or dramatically reduced its size and or depth within 2-13 weeks. Conclusion: In this study the use of IBFUSEC-BRH system enabled rapid healing of complicated wounds which had previously failed to heal. 2

3 INTRODUCTION The 21 st century, with its benefits for humans, brings with it some major health problems. One of it is the diabetes, which results due to the prolonged average living age, the types of commonly consumed nutrition causing obesity and the lack of physical activity. Once a person is diabetic, any limb wound may develop into hard to heal wound, also referred to as diabetic ulcer or foot infection. Foot infections are the most common problems in persons with diabetes. These individuals are predisposed to foot infections because of a compromised vascular supply secondary to diabetes. Local trauma and/or pressure (often in association with lack of sensation because of neuropathy), in addition to microvascular disease, may result in various diabetic foot infections that run the spectrum from simple, superficial cellulitis to chronic osteomyelitis. Infections in patients with diabetes are difficult to treat because these individuals have impaired microvascular circulation, which limits the access of phagocytic cells to the infected area and results in a poor concentration of antibiotics in the infected tissues. In addition, diabetic individuals can not only have a combined infection involving bone and soft tissue called fetid foot, a severe and extensive, chronic soft-tissue and bone infection that causes a foul exudate, but they may also have peripheral vascular disease that involves the large vessels, as well as microvascular and capillary disease that results in peripheral vascular disease with gangrene. Except for chronic osteomyelitis, infections in patients with diabetes are caused by the same microorganisms that can infect the extremities of persons without diabetes. Gas gangrene is conspicuous because of its low incidence in patients with diabetes, but deep-skin and softtissue infections, which are due to gas-producing organisms, frequently occur in patients with these infections. In general, foot infections in persons with diabetes become more severe and take longer to cure than do equivalent infections in persons without diabetes. Staging in diabetic foot infections is applicable only in cases of chronic osteomyelitis that require surgery. 3

4 Diabetic foot ulcers occur as a result of various factors, such as mechanical changes in conformation of the bony architecture of the foot, peripheral neuropathy, and atherosclerotic peripheral arterial disease, all of which occur with higher frequency and intensity in the diabetic population. Neuropathy causes loss of protective sensation and loss of coordination of muscle groups in the foot and leg, both of which increase mechanical stresses during ambulation. Diabetic foot lesions are responsible for more hospitalizations than any other complication of diabetes. Diabetes is the leading cause of nontraumatic lower extremity amputations in the United States, with approximately 5% of diabetics developing foot ulcers each year and 1% requiring amputation. Explanations of the Machine s Mode of Operation The BRH-A1 is a non-invasive application based on Ultrasonic resonant technology that is working at constant changing ultrasound frequency and intensity combined with Low Frequency Electric current fields. The BRH-A1 device demonstrates exceptional results in enhancing blood circulation, and catalyzing the healing process of chronic wounds. The BHR device uses the combination of both low intensity Ultrasound and electrotherapy. Ultrasound may induce thermal and non thermal physical effects in tissues. Non thermal effects can be achieved with or without thermal treatments. Thermal effects of ultrasound upon tissue may include increased blood flow, reduction in muscle spasm, increased extensibility of collagen fibers and a pro inflammatory response. It is estimated that thermal effects occur with elevation of tissue temperature to C for at least 5 min. 4

5 The rationale for applying electrical stimulation to chronic non-healing wounds is that it mimics the natural current of injury and will jump start or accelerate the wound healing process. The September 2009 international pressure ulcer guidelines (EPUAP and NPUAP) rated electrical stimulation as the only treatment for pressure ulcers with highest strength of evidence. Aim of the study The aim of this study was to exhibit the results of treatments with the BRH-A1on all 100% of the population of 4 devices in different locations in the world (initial population). This study is not a statistical study using a number of chosen patients. For this study, all 100% of 4 clinic's patients were included. In addition, this study examined the successful treatment with no relation to sex, age, and gender. 5

6 Study conditions and criteria This Pilot clinical assessments is, Multi-national Pilot clinical assesments. The study has been performed in Spain, Romania and Israel. The first location was Spain. Study performed by Dr. Malimovka Yariv MD Mobile: ) at the Mediterranean Medical Center, MMC, in Alicante, Spain. The second location was Romania. Study performed by Dr.Moti Yair Levy MD Mobile: ) at the Timisoara clinic, Bucharest, Romania. The third location was Israel. Study performed by Dr Drorit Attias MD, MSc Mobile: ) and Dr Eyal Attias MD Mobile: , General Surgery) at the Dr Eyal Attias Clinics, Jerusalem and Netania clinics, Israel. This study included all 100% of 4 clinic's patients that were treated with the BRH-A1. All subjects had undergone treatments to the affected area. The data was extracted from the computer memory of BRH-A1 units from all 4 clinics: 2 in Israel, 1 in Spain and 1 in Romania. Inclusion criteria: Patients performing 4 treatments and more Wounds were not healed for at least 6 months. 6

7 Age between 18 and 65 years Overall treatment duration extend up to 100 days Patients had undergone several previous treatments, and at the time of initiation of the BRH-A1 treatments other treatments were unhelpful any more. Exclusion criteria: None (all 100% of treated patients by the 4 devices) Method and process of study In accordance with the inclusion and exclusion criteria mentioned, 100% of subjects underwent an accurate clinical assessment and objective examination of their health state, making sure each patient is able to commit to treatments schedule and appear for at least the mandatory 4 treatments. Collection and documentation of the data A subject found suitable for treatment underwent the following process: 1. Patients who undergo BRH-A1 treatments were routinely asked several health related questions before each session using the BRH-A1sotware. The data was recorded. 2. The subject s wound measurements were taken with a standard measuring ruler. 7

8 3. Once defined, the borders of the treated wound area were marked, using a measuring ruler located close to the wound in the photo (for ratio). 4. The photos are taken after each treatment session. 5. After the photo is taken, the wound size can be accurately defined, using the BRH-A1 internal measuring software. The treated area's measurements were measured at each treatment session. Study Method and Process Treatments have been performed 1-4 times a week. The treated area was disinfected previous to each treatment. At the initiation of each treatment, the patient s health status data is recorded. At the end of each treatment session the treated wound s photos were taken. Data collection and documentation The data and photos are saved in the BRH-A1 internal memory, and can always be viewed and extracted by a simple USB memory key. The data and photos can t be changed nor altered. And any data and photos, extracted from the device, is an original. 8

9 Data Analysis The BRH-A1 has an ISCS (internal size calculation software) calculating the size of each photographed wound, so each wound size reduction can be automatically calculated for the full data record and analysis. In addition, the full health data recorded prior to each treatment session is saved and the changes in the health status during the whole treatment period are fully registered. Spain MMC Patients: Patient number: AS Area of Treatment: Left Foot medial aspect Number of Treatments: 11 Ulcer closed, no purulence 9

10 Patient number: AS Area of Treatment: Right Foot lateral aspect Number of Treatments: 8 Ulcer size reduced, minimal purulence Patient number: AS Area of Treatment: Right Foot medial aspect Number of Treatments: 4 Ulcer closed, no purulence 10

11 Patient number: AS Area of Treatment: Right Foot Number of Treatments: 7 Improvement in quality of skin Patient number: AS Area of Treatment: Left Foot medial aspect Number of Treatments: 6 Ulcer size reduced, minimal purulence 11

12 Patient number: AS Area of Treatment: both Ankles Number of Treatments: 4 each Skin improvement, blood circulation improvement, sensation regained Patient number: AS Area of Treatment: Right Foot medial aspect Number of Treatments: 5 Ulcer size reduced, improvement in odor 12

13 Patient number: AS03Y04-8 Area of Treatment: Right Foot medial aspect Number of Treatments: 3 Skin improvement, blood circulation improvement, sensation regained Patient number: AS Area of Treatment: Left Foot medial aspect Number of Treatments: 4 Ulcer closed, no purulence, sensation improvement 13

14 Patient number: AS Area of Treatment: Left Foot medial aspect Number of Treatments: 9 Ulcer closed, no purulence 14

15 Patient number: ASAAA-11 Area of Treatment: Left Foot Number of Treatments: 4 Ulcer closed, no purulence 15

16 Romania Timisoara patients: Patient number: BRDM1-12 Area of Treatment: right foot between toes; Wound has been open for 10 weeks Number of Treatments: 4 Ulcers size reduced, no purulence 16

17 Patient number: BRGD2-13 Area of Treatment: left calf medial aspect; Wound has been open for 18 weeks Number of Treatments: 9 Ulcer size reduced, no purulence Patient number: BRGA3-14 Area of Treatment: right heel; Wound has been open for 12 weeks Number of Treatments: 16 Ulcer depth reduced, less purulence 17

18 Patient number: BRNF4-15 Area of Treatment: right foot; Wound has been open for 25 weeks Number of Treatments: 16 Ulcer size and depth reduced, less purulence Patient number: BRPE5-16 Area of Treatment: left calf medial aspect; Wound has been open for 17 weeks Number of Treatments: 6 Ulcer size reduced, no purulence 18

19 Netania Israel Dr. Eyal Atias clinic Patients: Patient number: AM Area of Treatment: Left Foot Number of Treatments: 4 Ulcer closed, no pus provisions Patient number: MC Area of Treatment: Left Foot - side Number of Treatments: 13 Ulcer size reduced, no pus provisions 19

20 Jerusalem Israel Dr. Eyal Atias clinic Patients: Patient number: MH Area of Treatment: Right Hip Number of Treatments: 75 Ulcer size reduced, Significantly less pus provisions, Sensation regains Patient number: NB Area of Treatment: Right Back of Knee Number of Treatments: 3 Ulcer size reduced, Significantly less pus provisions growth of healthy tissue 20

21 Patient number: ABU Area of Treatment: Left Heel Number of Treatments: 25 Ulcer closed, no pus provisions growth of healthy tissue Study Results: The wounds of all 21 patients were improved within the study period. Pain was dramatically improved in 17 patients. 6 patient s wounds were completely closed; 3 additional were 95% closed; 7 patients very deep wounds depth was significantly less deep after the treatments, and puss provisions was reduced or stopped at all; 8 patient s wounds sizes were smaller in average of 80% close to closure; 5 patients skin color around the wound had improved to a near optimal color. 21

22 In 2 patients with a fistula from post-operative osteomyelitic lesions (total hip and knee replacement) the wounds closed, fistula stopped draining, and no collection was seen on ultrasound. In one patient with a knee replacement the pain did not change. All of the above was done within 2-13 weeks. Conclusion: The BRH system (IBFUSEC) enabled to perform what several well-known treatments with many years of experience has failed to achieve. In the specific examined severe and complicated wounds cases, the rapid healing and significant improve of pain level was a breakthrough 22

23 References 1. Lipsky BA, Armstrong DG, Citron DM, Tice AD, Morgenstern DE, Abramson MA. Ertapenem versus piperacillin/tazobactam for diabetic foot infections (SIDESTEP): prospective, randomised, controlled, double-blinded, multicentre trial. Lancet. Nov ;366(9498): [Medline]. 2. Lipsky BA, Giordano P, Choudhri S, Song J. Treating diabetic foot infections with sequential intravenous to oral moxifloxacin compared with piperacillintazobactam/amoxicillin-clavulanate. J Antimicrob Chemother. Aug 2007;60(2): [Medline]. [Full Text]. 3. Lipsky BA, Stoutenburgh U. Daptomycin for treating infected diabetic foot ulcers: evidence from a randomized, controlled trial comparing daptomycin with vancomycin or semi-synthetic penicillins for complicated skin and skin-structure infections. J Antimicrob Chemother. Feb 2005;55(2): [Medline]. [Full Text]. 4. Stein GE, Schooley S, Peloquin CA, Missavage A, Havlichek DH. Linezolid tissue penetration and serum activity against strains of methicillin-resistant Staphylococcus aureus with reduced vancomycin susceptibility in diabetic patients with foot infections. J Antimicrob Chemother. Oct 2007;60(4): [Medline]. [Full Text]. 5. Wang S, Cunha BA, Hamid NS, Amato BM, Feuerman M, Malone B. Metronidazole single versus multiple daily dosing in serious intraabdominal/pelvic and diabetic foot infections. J Chemother. Aug 2007;19(4): [Medline]. 6. Malabu UH, Al-Rubeaan KA, Al-Derewish M. Diabetic foot osteomyelitis: usefulness of erythrocyte sedimentation rate in its diagnosis.west Afr J Med. Apr-Jun 2007;26(2): [Medline]. 7. Tan PL, Teh J. MRI of the diabetic foot: differentiation of infection from neuropathic change. Br J Radiol. Nov 2007;80(959): [Medline]. [Full Text]. 23

24 8. US Food and Drug Administration. FDA Drug Safety Communication: Serious CNS reactions possible when linezolid (Zyvox ) is given to patients taking certain psychiatric medications. Available at Accessed July 27,