Abstract

BACKGROUND:

Nonhealing wounds are a major, functionally-limiting medical problem impairing quality of life for millions of people each year. Various studies report complete wound epithelialization of 48 to 56% over 30 to 65 d with different treatment modalities including ultrasound, topical rPDGF-BB, and composite acellular matrix. This is in contrast to comparison control patients treated with standard wound care, demonstrating complete epithelialization rates of 25 to 39%. Extracorporeal shock wave therapy (ESWT) may accelerate and improve wound repair. This study assesses the feasibility and safety of ESWT for acute and chronic soft-tissue wounds.

STUDY DESIGN:

Two hundred and eight patients with complicated, nonhealing, acute and chronic soft-tissue wounds were prospectively enrolled onto this trial between August 2004 and June 2006. Treatment consisted of debridement, outpatient ESWT [100 to 1000 shocks/cm(2) at 0.1 mJ/mm(2), according to wound size, every 1 to 2 wk over mean three treatments], and moist dressings.

RESULTS:

Thirty-two (15.4%) patients dropped out of the study following first ESWT and were analyzed on an intent-to-treat basis as incomplete healing. Of 208 patients enrolled, 156 (75%) had 100% wound epithelialization. During mean follow-up period of 44 d, there was no treatment-related toxicity, infection, or deterioration of any ESWT-treated wound. Intent-to-treat multivariate analysis identified age (P = 0.01), wound size < or =10 cm(2) (P = 0.01; OR = 0.36; 95% CI, 0.16 to 0.80), and duration < or =1 mo (P < 0.001; OR = 0.25; 95% CI, 0.11 to 0.55) as independent predictors of complete healing.

CONCLUSIONS:

The ESWT strategy is feasible and well tolerated by patients with acute and chronic soft tissue wounds. Shock wave therapy is being evaluated in a Phase III trial for acute traumatic wounds.