The management of neuropathic ulcers of the foot in diabetes by shock wave therapy

Biagio Moretti, Angela Notarnicola, Giulio Maggio, Lorenzo Moretti, Michele Pascone, Silvio Tafuri, Vittorio Patella, Biagio Moretti, Angela Notarnicola, Giulio Maggio, Lorenzo Moretti, Michele Pascone, Silvio Tafuri, Vittorio Patella

Abstract

Background: Diabetes is becoming one of the most common chronic diseases, and ulcers are its most serious complication. Beginning with neuropathy, the subsequent foot wounds frequently lead to lower extremity amputation, even in the absence of critical limb ischemia. In recent years, some researchers have studied external shock wave therapy (ESWT) as a new approach to soft tissue wound healing. The rationale of this study was to evaluate if ESWT is effective in the management of neuropathic diabetic foot ulcers.

Methods: We designed a randomized, prospective, controlled study in which we recruited 30 patients affected by neuropathic diabetic foot ulcers and then divided them into two groups based on different management strategies. One group was treated with standard care and shock wave therapy. The other group was treated with only standard care. The healing of the ulcers was evaluated over 20 weeks by the rate of re-epithelization.

Results: After 20 weeks of treatment, 53.33% of the ESWT-treated patients had complete wound closure compared with 33.33% of the control patients, and the healing times were 60.8 and 82.2 days, respectively (p < 0.001). Significant differences in the index of the re-epithelization were observed between the two groups, with values of 2.97 mm2/die in the ESWT-group and 1.30 mm2/die in the control group (p < 0.001).

Conclusion: Therefore, ESWT may be a useful adjunct in the management of diabetic foot ulceration.

Figures

Figure 1
Figure 1
The ulcer of case 9 in group A. The lesion was localized to the plantar surface of the 3rd intermetatarsal space and was 175 mm2 before ESWT.
Figure 2
Figure 2
Ulcer of case 9 in group A. The lesion healed after 52 days with a re-epithelization index of 3.4 mm2/die.
Figure 3
Figure 3
Ulcer of case 4 in group B. The lesion was localized to the plantar surface of the tarsus and was 145 mm2 before standard management.
Figure 4
Figure 4
Ulcer of case 4 in group B. The lesion healed after 90 days with a re-epithelization index of 1.6 mm2/die.
Figure 5
Figure 5
The steps of ultrasonic gel, plastic draping and shock wave administration at work in the study.

References

    1. Wu SC, Driver VR, Wrobel JS, Armstrong DG. Foot ulcers in the diabetic patient, prevention and treatment. Vasc Health Risk Manag. 2007;3:65–76.
    1. Boulton AJ, Vileikyte L. The diabetic foot: the scope of the problem. J Fam Pract. 2000;49:S3–8.
    1. Reiber GE. Epidemiology of foot ulcers and amputations in the diabetic foot. In: J Bowker H, Pfeifer MA, editor. The Diabetic Foot. St. Louis: Mosby; 2001. pp. 13–32.
    1. Dang CN, Boulton AJ. Changing perspectives in diabetic foot ulcer management. Int J Low Extrem Wounds. 2003;2:4–12. doi: 10.1177/1534734603002001002.
    1. Pinzur MS, Slovenkai MP, Trepman E, Shields NN, Diabetes Committee of American Orthopaedic Foot and Ankle Society Guidelines for diabetic foot care: recommendations endorsed by the Diabetes Committee of the American Orthopaedic Foot and Ankle Society. Foot Ankle Int. 2005;26:113–19.
    1. Singh N, Armstrong DG, Lipsky BA. Preventing foot ulcers in patients with diabetes. JAMA. 2005;293:217–28. doi: 10.1001/jama.293.2.217.
    1. Reiber GE. The epidemiology of diabetic foot problems. Diabet Med. 1996;13:S6–S11.
    1. Fernando DJ, Masson EA, Veves A, Boulton AJ. Relationship of limited joint mobility to abnormal foot pressures and diabetic foot ulceration. Diabetes Care. 1991;14:8–11. doi: 10.2337/diacare.14.1.8.
    1. Birke JA, Franks D, Foto JG. First ray joint limitation, pressure, and ulceration of the first metatarsal head in diabetes mellitus. Foot Ankle. 1995;16:277–84.
    1. Lavery LA, Wunderlich RP, Tredwell JL. Disease management for the diabetic foot: effectiveness of a diabetic foot prevention program to reduce amputations and hospitalizations. Diabetes Res Clin Pract. 2005;70:31–7. doi: 10.1016/j.diabres.2005.02.010.
    1. Frykberg RG, Lavery LA, Pham H, Harvey C, Harkless L, Veves A. Role of neuropathy and high foot pressures in diabetic foot ulceration. Diabetes Care. 1998;21:1714–19. doi: 10.2337/diacare.21.10.1714.
    1. Armstrong DG, Stacpoole-Shea S, Nguyen H, Harkless LB. Lengthening of the Achilles tendon in diabetic patients who are at high risk for ulceration of the foot. J Bone Joint Surg (Am) 1999;81A:535–8.
    1. Van Damme H, Limet R. The diabetic foot. Rev Med Liege. 2005;60:516–25.
    1. Brand PW. The insensitive foot (including leprosy) In: Jahss M, editor. Disorders of the Foot and Ankle. Philadelphia: Saunders; 1991. pp. 2170–5.
    1. Cavanagh PR, Ulbrecht JS, Caputo GM. Biomechanical aspects of diabetic foot disease: aetiology, treatment, and prevention. Diabet Med. 1996;13:S17–22.
    1. Wu SC, Driver VR, Wrobel JS, Armstrong DG. Foot ulcers in the diabetic patient, prevention and treatment. Vasc Health Risk Manag. 2007;3:65–76.
    1. Brand PW. The diabetic foot. In: Ellenberg M, Rifkin H, editor. Diabetes mellitus, theory and practice. New York: Medical Examination Publishing; 1983. pp. 803–28.
    1. Duckworth T, Betts RP, Franks CI, Burke J. The measurement of pressure under the foot. Foot and Ankle. 1982;3:130.
    1. Boulton AJM. The importance of abnormal foot pressure and gait in causation of foot ulcers. In: Connor H, Boulton AJM, Ward JD, editor. The foot in diabetes. Chilchester: John Wiley and Sons; 1987. pp. 11–26.
    1. Birke JA, Novick A, Graham SL, Coleman WC, Brasseaux DM. Methods of treating plantar ulcers. Phys Ther. 1991;71:116–22.
    1. Cavanagh PR, Ulbrecht JS, Caputo GM. Biomechanical aspects of diabetic foot disease: aetiology, treatment, and prevention. Diabet Med. 1996;13:S17–22.
    1. Armstrong DG, Peters EJ, Athanasiou KA, Lavery LA. Is there a critical level of plantar foot pressure to identify patients at risk for neuropathic foot ulceration? J Foot Ankle Surg. 1998;37:303–7. doi: 10.1016/S1067-2516(98)80066-5.
    1. Jeffcoate WJ, Macfarlane RM, Fletcher EM. The description and classification of diabetic foot lesions. Diabet Med. 1993;10:676–679.
    1. American Diabetes Association Foot care in patients with diabetes mellitus (Position Statement) Diabetes Care. 1996;19:S23–S24.
    1. Young MJ, Breddy JL, Veves A, Boulton AJM. The prediction of diabetic neuropathic foot ulceration using vibration perception thresholds. Diabetes Care. 1994;16:557–560. doi: 10.2337/diacare.17.6.557.
    1. Wieman JT, Smiell JM, Su Y. Efficacy and safety of a topical gel formulation of recombinant human platelet-derived growth factor-BB (becaplermin) in patients with chronic neuropathic diabetic ulcers: a phase III randomized placebo-controlled double-blind study. Diabetes Care. 1998;21:822–827. doi: 10.2337/diacare.21.5.822.
    1. Richard JL, Parer-Richard C, Daures JP, Clouet S, Vannereau D, Bringer J, Rodier M, Jacob C, Comte-Bardonnet M. Effect of topical basic fibroblast growth factor on the healing of chronic diabetic neuropathic ulcer of the foot: a pilot, randomized, double-blind, placebo-controlled study. Diabetes Care. 1995;18:64–69. doi: 10.2337/diacare.18.1.64.
    1. Gentzkow GD, Iwasaki SD, Hershon KS, Mengel M, Prendergast JJ, Ricotta JJ, Steed DP, Lipkin S. Use of dermagraft, a culture d human dermis, to treat diabetic foot ulcers. Diabetes Care. 1996;19:350–354. doi: 10.2337/diacare.19.4.350.
    1. Steed DL. The Diabetic Ulcer Study Group: Clinical evaluation of recombinant human platelet-derived growth factor for the treatment of lower extremity diabetic ulcers. J Vasc Surg. 1995;21:71–79. doi: 10.1016/S0741-5214(95)70245-8.
    1. Steed DL. Clinical evaluation of recombinant human platelet-derived growth factor for the treatment of lower extremity diabetic ulcers. Diabetic Ulcer Study Group. J Vasc Surg. 1995;21:71–8. doi: 10.1016/S0741-5214(95)70245-8.
    1. Gough A, Clapperton M, Rolando N, Foster AV, Philpott-Howard J, Edmonds ME. Randomised placebo-controlled trial of granulocyte-colony stimulating factor in diabetic foot infection. Lancet. 1997;350:855–9. doi: 10.1016/S0140-6736(97)04495-4.
    1. Donaghue VM, Chrzan JS, Rosenblum BI, Giurini JM, Habershaw GM, Veves A. Evaluation of a collagen-alginate wound dressing in the management of diabetic foot ulcers. Adv Wound Care. 1998;11:114–19.
    1. Hopf HW, Humphrey LM, Puzziferri N, West JM, Attinger CE, Hunt TK. Adjuncts to preparing wounds for closure: hyperbaric oxygen, growth factors, skin substitutes, negative pressure wound therapy (vacuum-assisted closure) Foot Ankle Clin. 2001;6:661–82. doi: 10.1016/S1083-7515(02)00008-6.
    1. Edelson GW, Armstrong DG, Lavery LA, Caicco G. The acutely infected diabetic foot is not adequately evaluated in an inpatientsetting. Arch Intern Med. 1996;156:2373–2378. doi: 10.1001/archinte.156.20.2373.
    1. Margolis DJ, Kantor J, Santanna J, Strom BL, Berlin JA. Risk factors for delayed healing of neuropathic diabetic foot ulcers: a pooled analysis. Arch Dermatol. 2000;136:1531–5. doi: 10.1001/archderm.136.12.1531.
    1. Apfel RE. Acoustic cavitation: a possible consequence of biomedical uses of ultrasound. Br J Cancer Suppl. 1982;5:140–6.
    1. Maisonhaute E, Prado C, White PC, Compton RG. Surface acoustic cavitation understood via nanosecond electrochemistry. Part III: Shear stress in ultrasonic cleaning. Ultrason Sonochem. 2002;9:297–303. doi: 10.1016/S1350-4177(02)00089-5.
    1. Delius M. Medical applications and bioeffects of extracorporeal shock waves. Shock Waves. 1994;4:55–72. doi: 10.1007/BF01418569.
    1. Grasel RP, Schweitzer ME, Kovalovich AM, Karasick D, Wapner K, Hecht P, Wander D. MR imaging of plantar fasciitis: edema, tears, and occult marrow abnormalities correlated with outcome. Am J Roentgenol. 1999;173:699–701.
    1. Rompe JD, Hopf C, Nafe B, Burger R. Low-energy extracorporeal shock wave therapy for painful heel: aprospective controlled single-bind study. J Orthop Trauma Surg. 1996;115:75–79. doi: 10.1007/BF00573445.
    1. Wang CJ. An overview of shock wave therapy in musculoskeletal disorders. Chang Gung Med J. 2003;26:220–32.
    1. Haupt G. Use of extracorporeal shock waves in the treatment of pseudarthrosis, tendinopathy and other orthopedic diseases. J Urol. 1997;158:4–11. doi: 10.1097/00005392-199707000-00003.
    1. Nishida T, Shimokawa H, Oi K, Tatewaki H, Uwatoku T, Abe K, Matsumoto Y, Kajihara N, Eto M, Matsuda T, Yasui H, Takeshita A, Sunagawa K. Extracorporeal cardiac shock wave therapy markedly ameliorates ischemia-induced myocardial dysfunction in pigs in vivo. Circulation. 2004;110:3055–61. doi: 10.1161/01.CIR.0000148849.51177.97.
    1. Uwatoku T, Ito K, Abe K, Oi K, Hizume T, Sunagawa K, Shimokawa H. Extracorporeal cardiac shock wave therapy improves left ventricular remodeling after acute myocardial infarction in pigs. Coron Artery Dis. 2007;18:397–404. doi: 10.1097/MCA.0b013e328089f19b.
    1. Meirer R, Kamelger FS, Huemer GM, Wanner S, Piza-Katzer H. Extracorporal shock wave may enhance skin flap survival in an animal model. Br J Plast Surg. 2005;58:53–7. doi: 10.1016/j.bjps.2004.04.027.
    1. Meirer R, Brunner A, Deibl M, Oehlbauer M, Piza-Katzer H, Kamelger FS. Shock wave therapy reduces necrotic flap zones and induces VEGF expression in animal epigastric skin flap model. J Reconstr Microsurg. 2007;23:231–6. doi: 10.1055/s-2007-981506.
    1. Kuo YR, Wu WS, Hsieh YL, Wang FS, Wang CT, Chiang YC, Wang CJ. Extracorporeal shock wave enhanced extended skin flap tissue survival via increase of topical blood perfusion and associated with suppression of tissue pro-inflammation. J Surg Res. 2007;143:385–92. doi: 10.1016/j.jss.2006.12.552.
    1. Schaden W, Thiele R, Kölpl C, Pusch M, Nissan A, Attinger CE, Maniscalco-Theberge ME, Peoples GE, Elster EA, Stojadinovic A. Shock wave therapy for acute and chronic soft tissue wounds: a feasibility study. J Surg Res. 2007;143:1–12. doi: 10.1016/j.jss.2007.01.009.
    1. Gerdesmeyer L, von Eiff C, Horn C, Henne M, Roessner M, Diehl P, Gollwitzer H. Antibacterial effects of extracorporeal shock waves. Ultrasound Med Biol. 2005;31:115–9. doi: 10.1016/j.ultrasmedbio.2004.08.022.
    1. Oi K, Fukumoto Y, Ito K, Uwatoku T, Abe K, Hizume T, Shimokawa H. Extracorporeal shock wave therapy ameliorates hindlimb ischemia in rabbits. Tohoku J Exp Med. 2008;214:151–8. doi: 10.1620/tjem.214.151.
    1. Tiele R. New Guidelines for ESWT. Neswletter ISMST. 2009;5:20.
    1. Saggini R, Figus A, Troccola A, Cocco V, Saggini A, Scuderi N. Extracorporeal shock wave therapy for management of chronic ulcers in the lower extremities. Ultrasound Med Biol. 2008;34:1261–71. doi: 10.1016/j.ultrasmedbio.2008.01.010.

Source: PubMed

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