Patients With Localized Edema Clinical Trial
Official title:
Proof-of-concept Study for Bioimpedance Based Monitoring of Venous Ulcers During Galvanic Stimulation
The research group will choose no more than 10 patients having a lower extremity venous
ulcer(s), less than 5cm diameter and with an estimated one month time of re-epithelization.
In this study the investigators will follow and monitor the healing of the wound and
effectiveness of compression therapy using bioimpedance measurement based method. The
investigators will also treat the wounds using periodical low intensity direct current
(LIDC) stimulation therapy.
Bioimpedance monitoring and wound stimulation functionalities are provided by a purpose
built wound patch. The patch features a printed 4 x 4 stimulation and impedance measurement
electrodes array (in contact with wound surface) surrounded by a 4-part dual purpose counter
and impedance reference electrodes (in contact with the intact skin surrounding the wound
area).
Objectives of the study
Primary: Proof-of-concept study of bioimpedance measurement based method for monitoring of
chronic wound healing and assessment of efficacy of compression therapy. Gathering
bioimpedance data from the patients with a lower extremity ulcer of venous etiology over
their healing process. The investigators will seek methods for processing the collected data
to find the best correlation with visually observed healing of the wound.
Secondary: Proof-of-concept study of periodical LIDC wound stimulation. The investigators
will compare the LIDC enhanced healing outcome with appropriate archived data of previous
studies performed in TAYS.
Other: Analysis of the received data and reliability evaluation of the methods. Gathering
relevant user feedback from medical personnel and patients.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label