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

NCT02101645 | Completed DMC

• 1 other identifier: R13148
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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).

Conditions

Patients With Lower Extremity Venous Ulcers; Patients With Localized Edema

Keywords

Bioimpedance; Venous ulcer; Edema; LIDC; Electrical stimulation

Outcome Measures

Primary Outcomes (1)

• 2-electrode bioimpedance data of wound and intact skin. 4-electrode bioimpedance data related to local interstitial fluid status of affected leg.

  We aim to determine how well bioimpedance measurement based method for monitoring of chronic wound healing and assessment of efficacy of compression therapy comply with the results of conventional wound monitoring methods. We will measure the impedance of the wound and intact skin from multiple locations using 2-electrode configuration. To obtain this a purpose built electrode array will be placed on the wound, covering also area of intact skin. The electrode array will also be used for determining the interstitial fluid status of the leg by 4-electrode impedance measurement.

  4 months

Secondary Outcomes (1)

• Low intensity direct current stimulation of wound.

  4 months

Other Outcomes (1)

• Patient and personnel questionaire results.

  2 months

Study Arms (1)

LIDC treatment and bioimpedance monitoring of venous ulcers.

EXPERIMENTAL

Lower extremity venous ulcers will be treated using periodical LIDC stimulation. Wound healing and edema reduction efforts will be monitored using bioimpedance based monitoring.

Procedure: Periodical low intensity direct current (LIDC) stimulation of wound.; Procedure: Compression therapy of swollen limbs.

Interventions

Periodical low intensity direct current (LIDC) stimulation of wound. PROCEDURE

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.

LIDC treatment and bioimpedance monitoring of venous ulcers.

Compression therapy of swollen limbs. PROCEDURE

Compression bandage is used for reducing swelling of the limbs.

LIDC treatment and bioimpedance monitoring of venous ulcers.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tampere University Hospital: lead
• Tampere University: collaborator
• Åbo Akademi University: collaborator
• Aalto University: collaborator

Study Sites (1)

Tampere University Hospital

Tampere, FI-33521, Finland

Location

Related Publications (5)

• 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.

  PMID: 21270623 RESULT

• Carley PJ, Wainapel SF. Electrotherapy for acceleration of wound healing: low intensity direct current. Arch Phys Med Rehabil. 1985 Jul;66(7):443-6.

  PMID: 3893385 RESULT

• 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.

  PMID: 16871217 RESULT

• 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.

  PMID: 21979844 RESULT

• 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.

  PMID: 19163817 RESULT

Related Links

• Micro-current treatment dressing for chronic wounds

MeSH Terms

Conditions

Varicose Ulcer; Edema

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Annikki Vaalasti, MD

  Tampere University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2014
• First Posted: April 2, 2014
• Study Start: March 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 13, 2015

Record last verified: 2015-05

Locations

FI (1)