Effects of shock waves in the treatment of chronic wounds.

• Register: ANZCTR
• Last refreshed on: 6 February 2017
• Main ID: ACTRN12617000075381
• Date of registration: 13/01/2017
• Prospective Registration: Yes
• Primary sponsor: Foundation of the Wroclaw Medical University
• Public title: Effects of shock waves in the treatment of chronic wounds.
• Scientific title: Clinical, pathomorphological, immunocytochemical and molecular characterization of the effects of extracorporeal shock waves (ESW) in patients with chronic wounds: a prospective, single-blinded, placebo-controlled, randomized clinical study with an in vivo and in vitro comparison.
• Date of first enrolment: 1/02/2017
• Target sample size: 60
• Recruitment status: Not yet recruiting
• URL: http://www.anzctr.org.au/ACTRN12617000075381.aspx
• Study type: Interventional
• Study design: Randomised controlled trial Parallel
• Phase: Not Applicable

Health Condition(s) or Problem(s) studied

chronic pressure ulcers

chronic venous ulcers

chronic diabetic ulcer

Intervention(s)

ESW with a planar (electromagnetic) or radial (pneumatic) ESW applicator will be administered once to Group I, and three times to Group II at one session per week for three weeks. Methodology and parameters of the active ESW stimulation will be set in accordance to the literature data for clinical trials, as follows: energy flux density (EFD) of 0.10 mJ/mm2, pressure (P) of 2,5 bars, the number of pulses will be depended on the ulcer size, with basically 300 pulses plus additional 100 impulses/cm2 of wound area with a frequency (f) of 5 Hz (duration ranged of 10-15 minutes). In the placebo in vivo group, the sham-ESW stimulation will be made without the biologically active component with using the special polyethylene cover at the top of ESW applicator heading to absorb the energy and limit its propagation towards patient's tissue.

The in vitro single ESW stimulation will be performed with the same ESW applicators, as for an in vivo intervention. Methodology of the active ESW stimulation will be set in accordance to the literature data for in vitro studies. We are going to use a various combinations of ESW parameters to determine the mechanism of biological action and to show the distinct border between positive and harmful ESW effect, as follows: EFD of 0.10, 0,20 or 0,50 mJ/mm2, pressure (P) of 2,5, 3,5 or 5,0 bars, the number of different pulses number (100, 200, 300, 500, 5000) with frequency (f) of 1 or 5 Hz (duration ranged of 10-20 minutes). In the placebo in vitro group, the sham-ESW will be conducted and the cells will be not exposed to ESW, but will be maintained outside of the incubator with the device off but in contact with the plates for the same period of time.

Biopsies from the wounds will be obtained from all patients qualified into study. The resulting biopsies will be used in pathomorphological and immunocytochemical tests of wound tissues, and will provide sufficient material to develop primary cell cultures. On the other hand, the in vitro testing will be conducted on the basis of primary cultures of human skin fibroblasts obtained by biopsy before the ESW stimulation, from wound tissue.