CENTRO DE PREVENCION Y SALVAMENTO DEL PIE DIABETICO SAN ELIAN
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1 CENTRO DE PREVENCION Y SALVAMENTO DEL PIE DIABETICO SAN ELIAN Preliminary outcomes of PBK use in several conditions from a diabetic foot center population Fermín Martínez De Jesús MD Veracruz-Mexico
2 Background Diabetic Foot it is a complex disease, where many variables interact continuously. Several treatment modalities are currently developing and under assessment. The use of tissue electrical stimulation is another newer field to be explored.
3 Current Clinical Uses Pain relief Spasms or muscular damage Arthritis Neuropathic pain Vascular pathologies Back pain
4 Standard Electro-therapy Systems Use galvanic or faradic currents Square waves in a simple manner OF-ON Useful for short term pain control or Relaxing muscles
5 PBK System Does not use current Extremely short volts impulses Billionths of a second Timing and power
6 PBK effects Cell and tissue alarm status Local release of TNFά & IL- B Local release of VEGF & increase of NO
7 In Brief Standard Electro-therapy. Relaxes muscle 2. Removes pain for a short time PBK Therapy. Relaxes muscle 2. Stimulates VEGF Dilates vessels more blood flow 3. Grows new vessels 3. Stimulates anti-inflammatories which reduces pain immediately 4. Attacks the cause of the pain, not just the symptoms 5. Removes pain for a long time 6. Improves muscle strength, mobility and flexibility
8 Background A In Vivo Journal published paper Ferroni P. Roselli M. Martini F, et al. Biological effects of a software-controlled Voltage Pulse Generator (PhyBack PBK-2C) on the Release of Vascular Endothelial Growth Factor. In vivo 2005;9: Debreceni L, Gyulai M, Debreceni A, Szabo K. Results of transcutaneous electrical stimulation (TES) in cure of lower extremity arterial disease. Angiology 995;46:63-8.
9 Ethics Because there is no reported side effects with the use of controlled electrical stimulation (PBK), and there is published basic research showing a release of VEGF and good proinflammatory response. We start to use PBK in some selected patients within a comprehensive care in our center.
10 Objective To analyze the use of PBK in several conditions from a diabetic foot Center population. CENTRO DE PREVENCION Y SALVAMENTO DE PIE DIABETICO SAN ELIAN
11 Patients and Method Population Al diabetic and non diabetic patients who presented a medical condition where PBK was indicated Site San Elian Center for prevention and Salvage of the Diabetic Foot Lapse 0 apr 2007 to 0 Aug 2007 Design Prospective and descriptive study CENTRO DE PREVENCION Y SALVAMENTO DE PIE DIABETICO SAN ELIAN
12 Patients and Method Primary Measurements Improvement of clinical conditions Diabetic Foot patients Total wound healing in Ischemia Neuropathy Neuropathy symptoms Non Diabetic Muscle contractures Pain Secondary Measurements Amputations Major & minors CENTRO DE PREVENCION Y SALVAMENTO DE PIE DIABETICO SAN ELIAN
13 San Elian Wound Care Protocol Initial assessment PEDIS classification for Research San Elian Wound Score & Grading Tampico Classification * Initial treatment Surgical debridment of necrotic tissues and abscess Wound cleanse with NpHSS * Hi- tech dressings Broad spectrum antibiotics Body Homeostasis * Martínez-De Jesus FR, Ramos-de la Medina A, Armstrong D, Stephanie W, et al. Efficacy and safety of neutral ph superoxidized solution in severe diabetic foot infections. International Wound Journal. (in press) 2007.
14 San Elian Wound Care Protocol Initial Treatment Etiology Treat limb ischemia & Infection Endovascular By-pass Reduce Edema Subsequent Treatment focused on Wound healing phase Hydrofiber Ag dressings Promogram Topical O2 VAC Keratinocytes skin cultures EPIFAST Skin grafts, flaps, traction Lazaro-Martinez JL, Garcia-Morales E, eit-montesinos JV, Martinez-de-Jesus FR, ragon-sanchez FJ. [Randomized comparative trial of a collagen/oxidized regenerated cellulose dressing in the treatment of neuropathic diabetic foot ulcers]. Cir Esp 2007;82:27-
15 Tampico Classification Adapted by Mtz. De Jesús A B C. Ischemia 2. Neuropathy 3. Mixed 3. ISCHEMIA&NEUROPATHY 3.2 NEUROPATHY & ISCHEMIA CENTRO DE PREVENCION Y SALVAMENTO DE PIE DIABETICO SAN ELIAN
16 Demographics Results n ( %) or Means ± SD Age Gender Male Female Non diabetics patients Years of diabetes duration HbAlc Neuropathy 66 ± ( 52.6) 9 (47.4) ± ± CENTRO DE PREVENCION Y SALVAMENTO DE PIE DIABETICO SAN ELIAN
17 Results Tampico Classification (Depth,infection,ischemia or neuropathy) n=7/9 n ( %) A3 superfitial mixed mainly neuropathic(mmn) B partial depth,ischemia B2 partial depth, neuropathic B3.2 partial depth, (MMN) C entire depth ischemia C2 entire depth, neuropathic C3. entire depth, (MM ischemia) 2(.8) (5.9) 3(7.6) 2(.8) 2(.8) (5.9) 6(35.3) CENTRO DE PREVENCION Y SALVAMENTO DE PIE DIABETICO SAN ELIAN
18 Results Fasting Glucose means ± SD ª phase 2ª phase 3ª phase 4ª phase 20 ± ± ± ± 8.7 ANOVA p<0.05 CENTRO DE PREVENCION Y SALVAMENTO DE PIE DIABETICO SAN ELIAN
19 Condition for PBK use in Diabetic Foot Results N=9 n Success For Diabetic Foot patients Wound healing adjuvant Neuropathic ulcer Ischemia Trombophlebitis and edema Knee muscle contracture For non diabetics patients Lumbar pain Neuropatic Pain Improvement of medical condition 7 CENTRO DE PREVENCION Y SALVAMENTO DE PIE DIABETICO SAN ELIAN
20 Results PBK INDICATION FAILURE >50% WH* 00% WH TOTAL Diabetic Foot Patients Wound Healing Adjuvant Ischemia Muscle Contracture 0 0 Trombophlebitis & Edema 0 0 TOTAL * WH= Wound Healing
21 Results Outcome Edema reduction Trombophlebitis Wound healing Adjuvant Ischemia Neuropathic wounds n * * n= sample from number of events not patients
22 Results Site of Doppler arterial obstruction For patients with ischemia n ( %) left Deep Femoral Poplíteal Posterior Tibial right Deep Femoral Poplíteal Posterior Tibial (2.5) (2.5) 6(75.0) 2 ( 33.3) 3(50.0) (6.7)
23 Results Neuropathic Symptoms * VALUE n Muscle decontracture Pain reduction Numbness reduction Tingling reduction Recovery of sensation * More than one per patient
24 Results Amputations N=8/7 n Minor Digits Metatarsal Major 7 6
25 Some pictures of patients at different stages of healing CENTRO DE PREVENCION Y SALVAMENTO DE PIE DIABETICO SAN ELIAN
26 Some pictures of patients at different stages of healing CENTRO DE PREVENCION Y SALVAMENTO DE PIE DIABETICO SAN ELIAN
27 Some pictures of patients at different stages of healing CENTRO DE PREVENCION Y SALVAMENTO DE PIE DIABETICO SAN ELIAN
28 Some pictures of patients at different stages of healing CENTRO DE PREVENCION Y SALVAMENTO DE PIE DIABETICO SAN ELIAN
29 Some pictures of patients at different stages of healing CENTRO DE PREVENCION Y SALVAMENTO DE PIE DIABETICO SAN ELIAN
30 Conclusions PBK appears to play a role as adjuvant therapy in improving different conditions in patients cared within a comprehensive care center. PBK Appear to produce an hypoglycemic effect. Further clinical trials are planned in order to increase the evidence level of these promissory preliminary findings CENTRO DE PREVENCION Y SALVAMENTO DE PIE DIABETICO SAN ELIAN
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