MedTrace Logo

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

NCT02101645 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2015-05-13

No results posted yet for this study

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).

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Tampere University

    collaborator OTHER

  • Åbo Akademi University

    collaborator OTHER

  • Aalto University

    collaborator OTHER

  • Tampere University Hospital

    lead OTHER

Principal Investigators

  • Annikki Vaalasti, MD · Tampere University Hospital

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Finland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02101645 on ClinicalTrials.gov