NCT02101645

Proof-of-concept Study for Bioimpedance Based Monitoring of Venous Ulcers During Galvanic Stimulation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Tampere University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Patients With Lower Extremity Venous Ulcers
• Patients With Localized Edema

Interventions

Type	Name	Description
PROCEDURE	Periodical low intensity direct current (LIDC) stimulation of wound.	Wound is stimulated using LIDC current. Stimulation current magnitude is in micro-ampere range. Stimulation sequence is 1 hour on and 1 hour off for 72 hours or 96 hours.
PROCEDURE	Compression therapy of swollen limbs.	Compression bandage is used for reducing swelling of the limbs.

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2014-04-02
• Last updated: 2015-05-13

Locations

1 site across 1 country: Finland