Clinical trial NCT02101645: Proof-of-concept Study for Bioimpedance Based Monitoring of Venous Ulcers During Galvanic Stimulation
Official title: Proof-of-concept Study for Bioimpedance Based Monitoring of Venous Ulcers During Galvanic Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients With Lower Extremity Venous Ulcers
Patients With Localized Edema
Keywords: Bioimpedance
Venous ulcer
Edema
LIDC
Electrical stimulation
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Tampere University
name: Åbo Akademi University
name: Aalto University
First posted: 2014-04-02
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Male or female patients with a chronic wound of venous origin.
* Patients have signed consent to participate in the study.
* Patient is motivated to follow the instructions given by medical personnel and research group.
* Age 18 - 80 years.
* Wound(s) is expected to heal significantly during the period of 2 months.
* Wound(s) is located so that there is enough space to place the experimental wound dressing appropriately.
* Diameter of a single wound is no more than 5 cm and wound edges are not steep. If patient has multiple small wounds, the wounds are located within an area of 5x5cm.
* Patient has adequate vascular supply and patient tolerates compression dressings.

Exclusion Criteria:

* Patient has an unstable coronary disease.
* Subject does not approve the informed consent.
* Subject is not appropriately motivated to follow M.D.'s instructions of treatment (at home).
* Participation in another clinical trial that involves an investigational drug or device that would interfere this study.
* Patient suffers from cognitive problem such as dementia.
* Wound is not expected to be healed during the time reserved for the measurements (circa 2 months).
* Patient has active wound infection or increased risk of wound infection.
* Skin changes or skin disease which could alter the epidermis of the electrode site during the measurement period.
* Patient has cancer or other life threatening disease in an unstable condition.
* Patient is pregnant.
* Patients with implantable electrical device. Such as pacemaker or implanted defibrillator.

Primary outcomes:
measure: 2-electrode bioimpedance data of wound and intact skin. 4-electrode bioimpedance data related to local interstitial fluid status of affected leg.
timeFrame: 4 months
Secondary outcomes:
measure: Low intensity direct current stimulation of wound.
timeFrame: 4 months
Other outcomes:
measure: Patient and personnel questionaire results.
timeFrame: 2 months
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Annikki Vaalasti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ward L, Winall A, Isenring E, Hills A, Czerniec S, Dylke E, Kilbreath S. Assessment of bilateral limb lymphedema by bioelectrical impedance spectroscopy. Int J Gynecol Cancer. 2011 Feb;21(2):409-18. doi: 10.1097/IGC.0b013e31820866e1.
citation: Carley PJ, Wainapel SF. Electrotherapy for acceleration of wound healing: low intensity direct current. Arch Phys Med Rehabil. 1985 Jul;66(7):443-6.
citation: Zhao M, Song B, Pu J, Wada T, Reid B, Tai G, Wang F, Guo A, Walczysko P, Gu Y, Sasaki T, Suzuki A, Forrester JV, Bourne HR, Devreotes PN, McCaig CD, Penninger JM. Electrical signals control wound healing through phosphatidylinositol-3-OH kinase-gamma and PTEN. Nature. 2006 Jul 27;442(7101):457-60. doi: 10.1038/nature04925.
citation: Blount AL, Foster S, Rapp DA, Wilcox R. The use of bioelectric dressings in skin graft harvest sites: a prospective case series. J Burn Care Res. 2012 May-Jun;33(3):354-7. doi: 10.1097/BCR.0b013e31823356e4.
citation: Weber SA, Gehin C, Moddy G, Jossinet J, McAdams ET. Characterisation of a multi-frequency wound impedance mapping instrument. Annu Int Conf IEEE Eng Med Biol Soc. 2008;2008:4907-10. doi: 10.1109/IEMBS.2008.4650314.