Difficult-to-heal wounds present imbalances in cytokine production, increases in MMP expression, high levels of apoptosis, and decreases in the proliferation of cells such as fibroblasts and keratinocytes, which are involved in tissue regeneration. CRET therapy (capacitive resistive electrical transfer therapy) has been shown to generate granulation tissue in in vitro assays. In addition, available clinical case reports and preliminary clinical trial results indicate that CRET can promote the regeneration of acute wounds and DHW (difficult-to-heal wounds).
Difficult-to-heal wounds present imbalances in cytokine production, increases in MMP expression, high levels of apoptosis, and decreases in the proliferation of cells such as fibroblasts and keratinocytes, which are involved in tissue regeneration. CRET therapy has been shown to be able to generate granulation tissue in in vitro assays. In addition, available clinical case reports and preliminary clinical trial results indicate that CRET can promote acute wound regeneration and CDH. The working hypothesis is that CRET treatment promotes the healing of CDH through its action in regulating inflammatory and regenerative processes in skin tissue. This non-invasive, cost-effective treatment, devoid of identified adverse effects, and not studied in depth so far in patients with CDH, can thus be placed in the treatment algorithms of CDH with the correct selection of candidate patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
137
Static Monopolar Capacitive Resistive Resistive Radiofrequency Equipment at 448 kHz
standard clinical procedures
Hospital Ramón y Cajal
Madrid, Spain
Wound dimensions before and after treatments in patients with HDC treated with CRET therapy plus standard treatment versus patients with HDC undergoing standard treatment alone.
Wound dimensions measurement (area, length and width) before and after treatments in patients with HDC treated with CRET therapy plus standard treatment versus patients with HDC undergoing standard treatment alone.
Time frame: 18 months
General clinical evaluation:
* age, * sex, * BMI * general medical history, * baseline blood work, * usual treatment
Time frame: 18 months
Wound evaluation:
* cause, * location, * time of evolution, * photographs.
Time frame: 18 months
Evaluation of biomarkers in peripheral blood of patients with CDH with or without CRET treatment:
Quantification of cytokines and growth factors: IL-1α, IL-1β, TNFα, IFγ.
Time frame: 18 months
In primary cultures of fibroblasts isolated from biopsies of CDH patients with or without CRET treatment, assessment of typical CDH biomarkers related to:
* Death: TUNEL assay; Bcl-2, Bcl-X and Caspase-3 markers. * Viability/proliferation: XTT, Ki67, p-p38 and p-ERK1/2 assays. * Adhesion: β -catenin and E-cadherin. * Extracellular matrix: α-SMA, Col I and Col III and the metalloproteinases, MMP8, MMP2 and MMP9.
Time frame: 18 months
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