Chronic wounds Skin and Connective Tissue Diseases
Conditions
Interventions
The study will cover 60 patients with grade II - IV pressure ulcers after the central nervous system damage (ischemic stroke or spinal cord injury) hospitalized in the Department of Neurological Rehab
Sponsors
Academy of Physical Education in Katowice
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female older than 18 years after stroke or spinal cord injury, with grade II-IV pressure ulcers in the trunk, hip girdle and lower limbs, who have a high risk of pressure ulcers (the Norton scale 15 points) 2. Consent to participate in the study
Exclusion criteria
Exclusion criteria: 1. Lack of consent to participate in the study 2. Malignant neoplasms 3. Allergies to standard medicines 4. Occurrence of acute inflammatory symptoms within the pressure ulcer 5. Black necrosis occurring within the pressure ulcer 6. Pressure ulcers qualifying for surgical treatment 7. Pressure ulcers occur on the lower legs or feet in patients with acute and chronic venous insufficiency and diabetes 8. Pressure ulcers with a surface area less than 0.5 cm² 9. Significant malnutrition (BMI 7%)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Healing rate of chronic wounds (pressure ulcers II-IV). The surface area of pressure ulcers will be measured by planimetry immediately before the start of treatment and then after the end of each of the 6 consecutive treatment weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Blood flow on the edges of chronic wounds will be measured by a non-invasive technique using laser Doppler flowmetry immediately before the start of treatment and then after 1, 2, 4 and 6 weeks of therapy 2. Concentration of pro-inflammatory cytokines (TNF-a, IL-1 and IL-6) and anti-inflammatory (IL-10) in the blood and liquid collected from the wound edges will be determined by the Enzyme-linked immunosorbent assay (ELISA) before and after 1, 2, 4 and 6 weeks of the experiment 3. Concentration of growth factors: transforming growth factor beta (TGF-ß), insulin-like growth factor type 1 (IGF-1), fibroblast growth factor (FGF), epidermal growth factor (EGF), vascular endothelial growth factor (VEGF) in blood and in liquid from the wounds' edges will be evaluated by the Enzyme-linked immunosorbent assay (ELISA) before and after 1, 2, 4 and 6 weeks of the experiment 4. Expression of genes responsible for cytokine synthesis (TNF-a, IL-1, IL-6 and IL-10) and growth factors (TGF-ß, IGF-1, FGF, EGF and VEGF) in the wound area of the pressure ulcer will be evaluated by PCR before and after 1, 2, 4 and 6 weeks of the experiment | — |
Countries
Poland
Outcome results
None listed