Evidence Supporting Extracorporeal Shockwave Therapy for Acute and Chronic Soft Tissue Wounds
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Clinical results showed completely healed ulcers in 57% and 25% (P = 0.003); ≥ 50% improved ulcers in 32% and 15% (P = 0.071); unchanged ulcers in 11% and 60% (P < 0.001) and none worsened for the ESWT and the HBOT group, respectively. Another interesting observation was that even though prior to study-based treatment levels of oxygenation were comparable, oxygenation levels were significantly higher after shockwave therapy than after HBOT (P = 0.002). On a tissue level, previous results showing increases in cell proliferation and decreases in cell apoptosis in the ESWT group as compared to the HBOT group were confirmed. The authors concluded that in chronic diabetic foot ulcers ESWT demonstrated better results than HBOT through significant improvement in blood flow perfusion rate and cell activity leading to better healing of the ulcers relative to HBOT.
Sanuwave, Inc. recently announced results of their pivotal Phase III clinical trial comparing the dermaPACE™ device (Sanuwave, Inc., Alpharetta, GA) to sham control for treatment of diabetic foot ulcers.54 Both groups received the standard of care according to the current literature combined with active (dermaPACE group) or inactive treatment (sham group). A total of 206 patients were enrolled in a double blinded, parallel-group sham control, 26-week clinical trial and were randomly assigned to one of the two study groups. Although the treatment group failed to meet its primary outcome, treatment with dermaPACE increased the proportion of diabetic foot ulcers that closed within 12 weeks by 36%, which was not a statistically significant result. Statistical significance was achieved at 12 weeks when 45% of device-treated and 26% of sham-treated patients had ≥ 90% wound closure. At the 12-week time point, 66% of device-treated and 47% of sham-treated patients had ≥ 70% wound closure. Throughout the entire 12-week period patients in the device treated group had reduced wound size compared to sham-treated patients (P = 0.0038 at week 6, P = 0.0018 at week 8, P = 0.0007 at week 10, and P = 0.0041 at week 12). At the 12-week time point, the average percent reduction in the target ulcer in patients treated with dermaPACE was 56% compared to only 7% in the patients randomized to receive sham treatment. During the 6-month follow up period, only 4.5% of the patients whose wounds closed at the 12-week time point returned due to recurrence.
ESWT for the treatment of urinary stones and orthopedic indications has been tested and shown to be effective. These shockwaves use high energy to destroy the urinary stones or tissue. The primary goal in the treatment of soft tissue wounds is to produce beneficial stimuli in the tissue, which stimulate and support tissue repair and regeneration. In contrast to the focused ESWT, shockwaves for the treatment of acute and chronic wounds are unfocused with low energy flux densities. Mechanism of transduction of mechanical force (shockwaves) into the complex biological response remains unknown, but potential targets are indentified and further research of this promising technology is imperative.
Current literature supports this treatment modality due to its efficacy, reproducibility, and virtually no adverse effects. Negative effects of chronic inflammation are suppressed after the treatment leading to improved wound healing, improved tissue perfusion, and increased blood vessel formation. Difficult to heal and chronic wounds show significant improvement after the treatment with a low rate of wound recurrence.