Patients With Lower Extremity Venous UlcersNCT02101645
Proof-of-concept Study for Bioimpedance Based Monitoring of Venous Ulcers During Galvanic Stimulation
A study testing Periodical low intensity direct current (LIDC) stimulation of wound. and Compression therapy of swollen limbs. in people with Patients With Lower Extremity Venous Ulcers and Patients With Localized Edema, run by Tampere University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Patients With Lower Extremity Venous Ulcers, Patients With Localized Edema
- What is being tested?
- Periodical low intensity direct current (LIDC) stimulation of wound. and Compression therapy of swollen limbs.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Being tested
- Periodical low intensity direct current (LIDC) stimulation of wound., Compression therapy of swollen limbs.
- Keywords
- Bioimpedance, Venous ulcer, Edema, LIDC, Electrical stimulation
- Medical subject headings
- Varicose Ulcer, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodical low intensity direct current (LIDC) stimulation of wound.Procedure or surgery
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.
Compression therapy of swollen limbs.Procedure or surgery
Compression bandage is used for reducing swelling of the limbs.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Periodical low intensity direct current (LIDC) stimulation of wound.; Procedure: Compression therapy of swollen limbs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Secondary outcomes (1)
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Patients With Lower Extremity Venous UlcersStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University, Åbo Akademi University, Aalto University
- Responsible party
- Sponsor
- Investigators
- Annikki Vaalasti, MD, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02101645
- Sponsor's protocol ID
- R13148
- Status last verified
- May 2015
- First submitted
- 26 Feb 2014
- Last updated
- 13 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21270623Carley PJ, Wainapel SF. Electrotherapy for acceleration of wound healing: low intensity direct current. Arch Phys Med Rehabil. 1985 Jul;66(7):443-6.
PubMed 3893385Zhao 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.
PubMed 16871217Blount 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.
PubMed 21979844Weber 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.
PubMed 19163817
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof-of-concept Study for Bioimpedance Based Monitoring of Venous Ulcers During Galvanic Stimulation
- ClinicalTrials.gov ID
- NCT02101645
- Acronym / sponsor ID
- R13148
- Keywords
- Bioimpedance, Venous ulcer, Edema, LIDC, Electrical stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Tampere University, Åbo Akademi University, Aalto University
- Study start
- Mar 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 2 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LIDC treatment and bioimpedance monitoring of venous ulcers. | Experimental | Procedure: Periodical low intensity direct current (LIDC) stimulation of wound., Procedure: Compression therapy of swollen limbs.Lower extremity venous ulcers will be treated using periodical LIDC stimulation. Wound healing and edema reduction efforts will be monitored using bioimpedance based monitoring. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | LIDC treatment and bioimpedance monitoring of venous ulcers. |
| Compression therapy of swollen limbs.Compression bandage is used for reducing swelling of the limbs. | Procedure or surgery | LIDC treatment and bioimpedance monitoring of venous ulcers. |
Primary outcome
2-electrode bioimpedance data of wound and intact skin. 4-electrode bioimpedance data related to local interstitial fluid status of affected leg.
Time frame: 4 months
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.
1 secondary outcome
Low intensity direct current stimulation of wound.
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2015.
- Results publication: PubMed 21270623Ward 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.
- Results publication: PubMed 3893385Carley PJ, Wainapel SF. Electrotherapy for acceleration of wound healing: low intensity direct current. Arch Phys Med Rehabil. 1985 Jul;66(7):443-6.
- Results publication: PubMed 16871217Zhao 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.
- Results publication: PubMed 21979844Blount 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.
- Results publication: PubMed 19163817Weber 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.
- Micro-current treatment dressing for chronic woundsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annikki Vaalasti, MD principal investigator
Tampere University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periodical low intensity direct current (LIDC) stimulation of wound. and Compression therapy of swollen limbs. in people with Patients With Lower Extremity Venous Ulcers and Patients With Localized Edema, run by Tampere University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-electrode bioimpedance data of wound and intact skin. 4-electrode bioimpedance data related to local interstitial fluid status of affected leg. (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02101645, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2015.