DESCRIPTION
Extracorporeal shock wave therapy (ESWT) has been used in the treatment of kidney stones for several decades. In recent years, ESWT has emerged as a proposed treatment of acute and chronic soft tissue wounds, including diabetic and pressure ulcers, burns, and surgical site wounds. The shock waves for ESWT are generated using an electrohydraulic, electromagnetic, or piezoelectric generator. For chronic wounds, ESWT is applied within 24 hours of wound debridement. Sterile ultrasound conducting gel is often applied to the wound surface, and a sterile plastic protective film is placed directly on the wound surface. Unfocused shock waves are then applied through the gel and the protective film to wounds. The density and duration of the shock waves vary according to the characteristics of the wound.
In 2017, the FDA permitted the marketing of DermaPace for chronic, full thickness diabetic ulcers no larger than 16 cm which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. Currently, the role of extracorporeal shock wave therapy in the treatment of wounds is uncertain.
POLICY
Extracorporeal shock wave therapy for the treatment of wounds is considered investigational.
IMPORTANT REMINDERS
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ADDITIONAL INFORMATION
Well controlled randomized trials comparing this technology to conventional wound management interventions are necessary to evaluate benefits and harms. The evidence is insufficient to determine the effects of the technology on health outcomes.
SOURCES
American College of Surgeons. (2013, September). Extracorporeal shock wave therapy for wound healing. Retrieved January 28, 2019 from https://www.facs.org/.
Butterworth, P.A., Walsh, T.P., Pennisi, Y.D., Chesne, A.D., Schmitz, C., & Nancarrow, S.A. (2015). The effectiveness of extracorporeal shock wave therapy for the treatment of lower limb ulceration: a systematic review. Journal of Foot and Ankle Research, 8, 3. (Level 2 evidence)
CMS.gov: Centers for Medicare & Medicaid Services. Palmetto GBA. (2021, February). Extracorporeal Shock Wave Therapy (ESWT). (LCD ID L38775). Retrieved October 22, 2021 from https://www.cms.gov.
Galiano, R., Snyder, R., Mayer, P., Rogers, L.C., & Alvarez, O. (2019). Focused shockwave therapy in diabetic foot ulcers: secondary endpoints of two multicentre randomised controlled trials. Journal of Wound Care, 28 (6), 383-395. Abstract retrieved February 2, 2021 from PubMed database.
Omar, M.T., Gwada, R.F., Shaheen, A.A., & Saggini, R. (2017). Extracorporeal shockwave therapy for the treatment of chronic wound of lower extremity: current perspective and systematic review. International Wound Journal, 14 (6), 898-908. (Level 1 evidence)
Snyder, R., Galiano, R., Mayer, P., Rogers, L.C., & Alvarez, O. (2018). Diabetic foot ulcer treatment with focused shockwave therapy: two multicentre, prospective, controlled, double-blinded, randomised phase III clinical trials. Journal of Wound Care, 27 (12), 822-836. Abstract retrieved February 2, 2021 from PubMed database.
U.S. Food and Drug Administration. (2017). FDA permits marketing of device to treat diabetic foot ulcers. Retrieved from http://www.fda.gov/.
Zhang, I., Weng, C., Zhao, Z., Fu, X. (2017). Extracorporeal shock wave therapy for chronic wounds: A systematic review and meta-analysis of randomized controlled trials. Wound Repair and Regeneration, 25 (4), 697-706. (Level 2 evidence)
ORIGINAL EFFECTIVE DATE: 5/31/2019
MOST RECENT REVIEW DATE: 3/14/2024
ID_BT
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