2018 Volume 30 Issue 3 Pages 231-240
OBJECTIVE: The chief cause of skin ulcers occurring in systemic scleroderma is ischemia, which is a refractory condition that occurs frequently. Treatment for such ulcers currently comprises vasodilators, anticoagulants, and antiplatelet agents. However, satisfactory results have not been obtained in many cases. This condition often severely affects the patient’s social life and the existing treatment is very expensive. Therefore, a new treatment method is urgently needed.
When any novel therapy is introduced, its usefulness needs to be proved through a verification study. We are trying to establish low-energy shock wave therapy as a novel treatment for this condition.
METHOD: To conduct the verification study, it is necessary to gather basic information to determine the study design. Therefore, observational research to examine the natural history of cutaneous ulcers at the time of conventional treatment and clinical trial as a proof of concept（POC）study to search for efficacy/safety when performing low-energy shock wave therapy.
RESULTS : A new verification study was designed based on the results obtained from two clinical studies, observational studies of natural history when conventional treatment was performed, and a POC study using low-energy shock wave therapy.
In fact, doctor-initiated clinical trials were implemented based on this and the analysis of the results is currently underway.
