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| Name | Class |
|---|---|
| Tampere University | OTHER |
| Ã…bo Akademi University | OTHER |
| Aalto University | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Annikki Vaalasti, MD | Tampere University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampere University Hospital | Tampere | FI-33521 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21270623 | Result | 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. | |
| 3893385 | 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. |
| Label | URL |
|---|---|
| Micro-current treatment dressing for chronic wounds | View source |
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| Compression therapy of swollen limbs. | Procedure | Compression bandage is used for reducing swelling of the limbs. |
|
| 16871217 | 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. |
| 21979844 | 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. |
| 19163817 | 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. |
| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| D004487 | Edema |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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