Evidence Supporting Extracorporeal Shockwave Therapy for Acute and Chronic Soft Tissue Wounds
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Relative to controls, ESWT was associated with significantly (P = 0.001) decreased pain, which is consistent with the findings of others.44,45
Among the most serious complications of diabetes is a chronic ulcer that can lead to limb amputation. Following the finding that ESWT increases local tissue perfusion and improves angiogenesis, Moretti et al46 conducted a prospective, randomized, controlled study with 30 patients affected by neurotrophic diabetic foot ulcers. Patients were randomly assigned to receive either standard of care (debridement, off-loading, and treatment of infection) or standard of care plus ESWT. Healing was evaluated by measuring the rate of epithelialization during a 20-week study period. Complete wound healing was observed in 53% of shockwave-treated patients compared to 33% in patients treated with standard of care alone. Time to complete healing was also significantly improved in the ESWT group (61 vs. 82 days; P = 0.001).
In a double-blinded, randomized, crossover study, Larkin et al47 measured the healing rate of static, chronic ulcers in 8 patients with chronic neurological conditions and chronic decubitus ulceration after ESWT treatment. Of 9 ulcers included in the study, 5 were on the buttocks, sacrum, and trochanter, and 4 were on the distal extremity. Patients were randomly assigned to receive ESWT or placebo treatment for 4 weeks. After this 4-week period and a 2-week washout period, study crossover to the other treatment ensued. Interestingly, regardless of which group they belonged to (initial treatment group or cross-over treatment group) all 9 ulcers showed significant improvement (average of 3 measurements of ulceration were recorded) at 6–8 weeks after the initial shockwave treatment.
Therapeutic wound oxygenation improves wound healing and prevents infection as shown in animal models and in clinical trials.9 It is commonly used as an adjunct to the treatment of chronic, diabetic foot ulcers applied either topically or through hyperbaric chambers.48–51 Hyperbaric oxygen therapy (HBOT) is applied for 60–120 min, 5 times per week for a total of 10–30 treatments. Wang et al52 reported that ESWT appeared to be more effective than HBOT. Seventy-two patients with 72 chronic diabetic foot ulcers were enrolled and randomly divided into two groups: 34 patients with 36 ulcers in the ESWT group and 36 patients with 36 ulcers in the HBOT group. The ESWT group received 300 + 100/cm2 impulses of shockwave at 0.11 mJ/cm2 energy flux density every 2 weeks for a total of 6 weeks, whereas patients in the HBOT group received HBOT daily for 20 treatments. Outcome variables included clinical assessment of the ulcers with photo documentation, blood flow perfusion scan, bacteriological examination, histological study, and immunohistochemical analysis. In the ESWT group, 31% completely healed, 58% of wounds improved, and 11% remained unchanged versus 22% completely healed, 50% improved, and 28% unchanged in the HBOT group. Improved local perfusion and increased cell concentration and activity were shown in the ESWT group. On a tissue level, the ESWT group demonstrated significant increases in endothelial nitric oxide synthase, vessel endothelial growth factors, proliferation of cell nuclear antigen expression, and a decrease in transference-mediated digoxigenin-deoxy-UTP nick end-labeling expression. The same authors repeated the evaluation in 2011.53 The ESWT group consisted of 39 patients with total of 44 chronic diabetic foot ulcers while the HBOT group consisted of 38 patients and 40 foot ulcers. The ESWT group received shockwave therapy twice per week for a total of six treatments, and the HBOT group received hyperbaric oxygen therapy daily for a total 20 treatments.