None listed
Conditions
Brief summary
Chronic soft tissue wounds of the compression etiology are suffered by millions of people around the world, and the annual occurrence is steadily increasing. In the era of an ageing societies, They constitute a serious problem of the healthcare system for elderly people. Effective treatment strategies, for difficult to heal, chronic wounds of soft tissues, still are the significant interdisciplinary medical problem. This type of healthcare is a challenge for internal medicine, dermatology, traumatology, surgery, or angiology, but also for nurses and physiotherapists. The scientific objective is an objective analysis of cellular and physiological mechanisms activated under the influence of ESW (Extracorporeal Shock Wave) within human chronic wounds. During the course of this project, a series of examinations will be carried out on cellular, histological and physical mechanisms associated with a complex and dynamic process of healing of chronic wounds (pressure ulcers). Authors of the project assume that the physical stimulus such as the ESW will bring significantly better treatment results as the effect of stimulating cellular and physiological mechanisms which promote regeneration and healing of pressure ulcers in combination with the effects obtained by placebo-controlled trials. Simultaneously, there will be in vitro tests carried out on a cellular model of wound healing with a one-off ESW application. Tests will be conducted on primary cultures of fibroblasts and keratinocytes obtained from the wounds of patients and on the reference cell lines of these cells which represent the reference group. Appropriate in vitro test methods will be used to determine cell viability, proliferation index, cell death and cellular ageing, their ability of transformation into myofibroblasts and displacement within the cellular model of wound healing. The transduction phenomena of the mechanical signals of the ESW into cell signalling (mechanotransduction) will also be the subject of assessment. For these purposes will also be tested a proliferation, differentiation and transdifferentiation of cells involved in the regeneration of tissues at the cellular and molecular level comprising the examination of altered patterns of gene expression. Tests will be performed in the context of the registration of physiological and pathomorphological changes, which will be verified in the following stage by analyses on cells, genes expression and molecular tests. The whole in vivo study will be completed with in vitro tests on a cellular wound model, which fits into the model of a multi-faceted research project based on the principles of translational medicine.
Interventions
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/c
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.
Sponsors
Foundation of the Wroclaw Medical University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Chronic wound (ChW) diagnosed as pressure, diabetic or venous etiology, 2. ChW surface area more than 3 cm2 of the ChW surface (due to do the biopsy) but less than 20 cm2 (to large area), 3. ChW duration more than 3 months (to be classified as a ChW), but less than 24 months (to be not classified as hard-to-heal), 4. ChW classified as 2nd grade (deep skin sore) or 3rd grade (the subcutaneous tissue damage with mild necrosis), 5. Obtain voluntary and informed consent of the patient to participate in the study.
Exclusion criteria
1. Acute wounds (surgical, traumatic, burns), 2. ChW size area less than 3 cm2 and more then 20 cm2, 3. ChW duration less than 3 months and more then 24 months, 4. ChW infection clinically confirmed, 5. ChW classified as 1st or 4th grade, 6. ChW with necrotic or infection events, 7. Contraindications for ESW stimulation (pregnancy or ovulation, cancer or malignancy, electronic or metal implants, acute or recurrent inflammations, bleeding tendency), 8. The lack of informed consent, 9. Failure to comply with the study protocol.
Outcome results
None listed