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Randomized, controlled clinical pilot study of venous leg ulcers treated with using two types of shockwave therapy
Dolibog P, Dolibog P, Franek A, Brzezinska-Wcislo L, Arasiewicz H, Wrobel B, Chmielewska D, Ziaja J, Blaszczak E
International Journal of Medical Sciences 2018 Aug 6;15(12):1275-1285
clinical trial
5/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: Venous leg ulcers are difficult to heal wounds. The basis of their physiotherapeutic treatment is compression therapy. However, for many years, the search for additional or other methods to supplement the treatment of venous ulcers, which would shorten the duration of treatment, is underway. One of such methods is the shockwave therapy. METHODS: The purpose of our study was to compare radial shockwave therapy (R-ESWT) with focused shockwave therapy (F-ESWT) in venous leg ulcers treatment. Patients were randomly assigned to tree groups. In the first group the radial shockwave therapy (0.17mJ/mm2, 100 impulses/cm2, 5 Hz), in the second group the focused shockwave therapy (0.173mJ/mm2, 100 impulses/cm2, 5 Hz) was used and in third group standard care was used. Patients in shockwave therapy groups were given 6 treatments at five-day intervals. Total area, circumference, Gilman index, maximum length and maximum width of ulcers were measured. The patients from the third group wet gauze dressing with saline and gently compressing elastic bandages were used (standard wound care SWC). RESULTS: Analysis of the results shows that a complete cure of ulcers was achieved in 35% of patients who were treated with radial shockwave, 26% of patients with focused shockwave used. There is statistically significant difference between the standard care and radial shockwave therapy as well as between the standard care and focused shockwave therapy. There is no statistically significant difference between the use of radial and focused shockwave in the treatment of venous leg ulcers (p > 0.05). CONCLUSION: There is no statistically significant difference between the use of radial and focused shockwave in the treatment of venous leg ulcers. Treatment of venous leg ulcers with shockwaves is more effective than the standard wound care.

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