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- 1. THE USE OF A PORTABLE , WEARABLE FORM OF PULSED RADIOFREQUENCY ELECTROMAGNETIC ENERGY DEVICE FOR THE HEALING OF RECALCITRANT ULCERS Ian M Rawe1, Ph.D and Tracey C Vlahovic2, DPM 1. Bioelectronics Corporation, Frederick , Maryland. 2. Temple University School of Podiatric Medicine, Philadelphia, Pennsylvania, USA. Introduction Treatment and Results Case Study #2 Venous stasis ulcer received after fall in 2009, amputation was After informed consent, patients adopted a protocol that Pulsed radio frequency electromagnetic field therapy (PRFE) considered before treatment began with Recovery Rx. The utilized the PRFE device for six to eight hours per day. The has potential to be an effective adjunct therapy for promoting wound improved rapidly and the patient was removed from patients with diabetic ulcers, had their wounds covered with the healing of chronic wounds, shown by a significant number the amputation list. moist saline gauze, PRFE device, and a dry sterile dressing. of published studies. However, the current treatment regimens When the PRFE device was not in use, the ulcer was covered have been delivered by mains powered devices requiring 2 x 30 with moist saline gauze and dry sterile dressing. Compression min twice daily treatments, have limited its adoption as a therapy was continued with patient 1 along with the PRFE widely used therapy. device for 6-8 hours per day. The PRFE device uses a carrier Diapulse: BioElectronics frequency of 27.12MHz, peak power of 94mwatts at 1KH. A fixed clinic based PRFE RecoveryRx: device with a daily 2 x 30 Wearable PRFE device min treatment regime weighing 8g which Table 1. The wound size (centimeters) data of each patient at week 0 (start of Patient: 105 yr old with a diabetic ulcer present for 2 yrs. operates for 1 week of treatment) and for each week of the 6 week study period. Treated with RecoveryRx PRFE therapy. The ulcer began to heal continuous therapy Patient Age Location Week 0 Week 1 Week 2 Week 3 Week 4 Week5 Week 6 after 2 weeks treatment and closed after 12 weeks of PRFE therapy 1 66 right leg 4 x 2.5 4 x 2.3 4x2 3 x 1.5 2 x 1.5 1 x 0.7 0.7 x 0.5 2 60 right foot 0.5 x 0.5 0.3 x0.3 0.2 x 0.1 ulcer healed 3 43 left heel 4 x 1 2 x 0.5 1 x 0.3 ulcer healed 2.5 x BioElectronics has developed lightweight wearable PRFE 4 74 right heel 1.75 2X2 2 X 1.5 1.7 X 0.7 1 X 1 1 X 0.5 1 X 0.5 devices making it an easy to use therapy. These devices emit a lower energy level, compensated for by extended treatment Figure 1. The venous stasis ulcer of patient 1 is shown at week 0 , week 2, week, times. This concept was first developed and proven by Dr 4 and week 6 of PRFE treatment. Significant pain relief was reported by the Bentall: (R.H.C. Bentall. Low-level pulsed radiofrequency fields patient after 2 weeks treatment. The ulcer had decreased in size from 4.0 x 2.5 and the treatment of soft tissue injuries. Bioelectrochemistry cm to 0.7 x 0.5 cm after 6 weeks treatment. The ulcer continued onto healing and Bioenergetics, 16 (1986) 531-548.) using the PRFE therapy. Patient History Discussion Pulsed radiofrequency electromagnetic fields have shown to be effective in promoting the healing of chronic wounds Patient 1: 72yr with type II diabetes - venous stasis ulcer (reference table). multilayer compression therapy for 4 weeks without any The results from these pilot studies suggest that extended use appreciable healing. PRFE therapy devices maybe an effective adjunct therapy for Patient 2: 42 yr old type II diabetes and an actively working recalcitrant wounds promoting healing and reducing pain. The Figure 2. The left heal ulcer of patient 3. The ulcer improved rapidly truck driver. Prior treatment - wound debridement, Promogran ease of use, low cost and compatibility with current with PRFE treatment, recovering 50% of the wound area after 1 week of matrix, and dry sterile dressing. Once the PRFE device was conventional therapy also suggest this form of wearable PRFE PRFE treatment. The ulcer progressed to complete healing at 3 weeks. added to the regimen, Promogran was discontinued. device could be widely applied as a first choice therapy. The ulcer is shown at week 0, week 1, week 2 and week 3. Patient 3: 62 yr old patient with diabetes, prior treatment - Salzberg, C. A., Cooper-Vastola, S. A., Perez, F. J., et al. (1995). The effects of non-thermal pulsed electromagnetic energy 1995 Pressure ulcers (Diapulse) on wound healing of pressure ulcers in spinal cord-injured patients: a randomized double-blind study. debridement and application of triple antibiotic ointment with Wounds 7(1):1116. Kloth, L. C., Berman, J. E., Sutton, C. H., et al. (1999). Effect of pulsed radio frequency stimulation on wound healing: a offloading. Once the PRFE device was added, triple antibiotic 1999 Pressure ulcers double-blind pilot study. In: Bersani, F. Electricity and Magnetism in Biology and Medicine (pp. 875878). New York: Academic/Plenum. was discontinued. 1996 Pressure ulcers Seaborne, D., Quirion-DeGirardi, C., Rousseau, M., et al. (1996). The treatment of pressure sores using pulsed electromagnetic energy (PEME). Physiother. Cancer 48:131137. Patient 4: 74 yr old diabetic right heel decubitus ulcer. Patient 1991 Stage II-III pressure ulcers Itoh, M., Montemayor, Jr, J. S., Matsumoto, E., et al. (1991). Accelerated wound healing of pressure ulcers by pulsed high peak power electromagnetic energy (Diapulse). Decubitus 4:2425, 2934. had previously a below knee amputation on the left side. The 1995 Stage II,III and IV decubitus Tung, S., Khaski, A., Milano, E., et al. (1995). The application of diapulse in the treatment of decubitus ulcers: case ulcers reports. Contemp. Surg. 47:2733. right heel wound was granular and non-infected. Prior 2008 Complex diabetic foo wounds Larsen, J. A., Overstreet, J. (2008). Pulsed radio frequency energy in the treatment of complex diabetic foot wounds. J. WOCN 35(5): 523527. treatment - offloading with a protective boot, debridement, 2008 Stage III and IV pressure ulcers Porreca, E. G., Giordano-Jablon, G. M. (2008). Treatment of severe (stage III and IV) chronic pressure ulcers using pulsed radio frequency energy in a quadriplegic patient. Eplasty 8:e49. Frykberg, R., Tierney, E., Tallis, A., et al. (2009). Cell proliferation induction: healing chronic wounds through low-energy Promogran matrix, and dry sterile dressing. Once the PRFE 2009 Chronic wounds pulsed radiofrequency. Int. J. Low Extrem. Wounds 8:4551. Fletcher, S. (2011). Successful treatment of venous stasis ulcers with combination compression therapy and pulsed radio device was used, weekly debridement and offloading was 2011 Venous stasis ulcers frequency energy in a patient scheduled for amputation. J Wound Ostomy Continence Nurs 38, 91-94. Rawe, I.M., and Vlahovic, T.C. (2011). The use of a portable, wearable form of pulsed radio frequency electromagnetic maintained. 2011 Chronic wounds energy device for the healing of recalcitrant ulcers: A case report. Int Wound J. Frykberg, R.G., Driver, V.R., Lavery, L.A., Armstrong, D.G., and Isenberg, R.A. (2011). The Use of Pulsed Radio Frequency 2010 Chronic wound registry Energy Therapy in Treating Lower Extremity Wounds: Results of a Retrospective Study of a Wound Registry. Ostomy Wound Manage 57, 22-29. Maier M. Pulsed radio frequency energy in the treatment of painful chronic cutaneous wounds: a report of two cases. 2011 Chronic cutaneous wounds Pain Med. 2011 May;12(5):829-32