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Active Not RecruitingNCT05953935

Effect Of Resistive Capactive Electrical Transfer Therapy In Difficult-to-heal Wounds

Effect Of Resistive Capactive Electrical Transfer Therapy On Wound Healing And Biomarker Expression In Difficult-to-heal Wounds

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
137 (estimated)
Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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).

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DEVICEOKTOStatic Monopolar Capacitive Resistive Resistive Radiofrequency Equipment at 448 kHz
DEVICEStandard clinical proceduresstandard clinical procedures

Timeline

Start date
2024-01-31
Primary completion
2024-07-31
Completion
2025-06-01
First posted
2023-07-20
Last updated
2024-09-19

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT05953935. Inclusion in this directory is not an endorsement.