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).
| Status | Completed |
| Enrollment | 6 |
| Est. completion date | December 2014 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| Finland | Tampere University Hospital | Tampere |
| Lead Sponsor | Collaborator |
|---|---|
| Tampere University Hospital | Aalto University, Åbo Akademi University, University of Tampere |
Finland,
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Carley PJ, Wainapel SF. Electrotherapy for acceleration of wound healing: low intensity direct current. Arch Phys Med Rehabil. 1985 Jul;66(7):443-6. — View 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. — View Citation
Weber SA, Gehin C, Moddy G, Jossinet J, McAdams ET. Characterisation of a multi-frequency wound impedance mapping instrument. Conf Proc IEEE Eng Med Biol Soc. 2008;2008:4907-10. doi: 10.1109/IEMBS.2008.4650314. — View 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 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Patient and personnel questionaire results. | After the final patient visit, a questionaire will be given to patients and personnel. Questionaire will provide the research group valuable information for further development of the study method and equipment. | 2 months | No |
| Primary | 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 | No |
| Secondary | Low intensity direct current stimulation of wound. | We will compare the LIDC enhanced healing outcome with appropriate archived data of previous studies performed in Tampere University Hospital. | 4 months | Yes |