Chronic Venous Hypertension With Ulcer and InflammationNCT01561170
Electromagnetic Field Therapy to Improve Healing of Chronically Venous Ulcer
An observational study of Chronic Venous Hypertension With Ulcer and Inflammation and Venous Ulcer Pain, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
Trial summary
Chronically venous ulcer in lower extremities is a permanent and disabling disease. Venous insufficience is the main cause of chronic ulcer. There is a high prevalence and frequency of the disease, primarily among elderly people. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Venous Hypertension With Ulcer and Inflammation, Venous Ulcer Pain
- What is being tested?
- Active Pulsed Electro-Magnetic Field (PEMF)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2011to Jun 2015
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- Patients who suffer from ulcer in lower extremities
- Patients who suffer from venous insufficience detected by duplex scanning or by a pressure on digits > 40 mmHg
- Patients with a regular need of compression stockings
- Age > 18 years
Who cannot join
- Age < 18 years
- Unability to read or understand Danish
- Patients who suffer from manifest neoplastic disorder
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Northern Orthopaedic Division, Aalborg University Hospital,
Aalborg
About this study
Official title: The Effect of Electromagnetic Field Therapy to Improve Healing of Chronically Venous Ulcer in Lower Extremities
Chronically venous ulcer in lower extremities is a permanent and disabling disease. Venous insufficience is the main cause of chronic ulcer. There is a high prevalence and frequency of the disease, primarily among elderly people. Recently, electromagnetic field therapy has been tested on various diseases in musculoskeletal system with a beneficial effect. In recent years, there has been an increasing interest in using electromagnetic field therapy to treat chronically venous ulcer.
The hypothesis of the investigators is that the electronic magnetic field therapy improves the healing process and reduces pain for patients suffering from chronically venous ulcer. The investigators assume that the bioactivity is affected by a cellular response which affects the DNA synthesis, transcription og protein synthesis.
- Being tested
- Active Pulsed Electro-Magnetic Field (PEMF), Placebo Pulsed Electro-Magnetic Field (PEMF)
- Keywords
- Electromagnetic, Field therapy, Chronically venous ulcer, Venous insufficiens
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Pulsed Electro-Magnetic Field (PEMF)Device
Also called No other names.
One group of patients receive active devices. Both patients and investigator are blinded.
Placebo Pulsed Electro-Magnetic Field (PEMF)Device
Also called No other names.
One group of patients receive placebo devices. Both patients and investigator are blinded.
| Study group | Role | What they receive |
|---|---|---|
| Chronically venous ulcer | A group of 36 patients Receives: Device: Active Pulsed Electro-Magnetic Field (PEMF); Device: Placebo Pulsed Electro-Magnetic Field (PEMF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of ulcerous area.
Measurement of ulcerous area in order to assessing the effect of the healing process.
Measured: 3 months
Secondary outcomes (1)
Pain reduction in proportion to Visual Analogue Scale (VAS).
The pain reduction will be measured by VAS and an analysis of the medication between the two group of patients will be carried out in order to measure quality of life, adverse effects, ulceration, granulation tissue etc.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2012 (estimated)
- Study startOct 2011
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Venous Hypertension With Ulcer and InflammationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vesal Khalid, M.D., Study chair, Northern Orthopaedic Department, Aalborg University Hospital, DenmarkNils Johannesen, M.D., Study chair, Cardiology Department, Aalborg University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01561170
- Sponsor's protocol ID
- N-20110052
- Status last verified
- Apr 2015
- First submitted
- 19 Mar 2012
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Electromagnetic Field Therapy to Improve Healing of Chronically Venous Ulcer in Lower Extremities
- ClinicalTrials.gov ID
- NCT01561170
- Acronym / sponsor ID
- N-20110052
- Keywords
- Electromagnetic, Field therapy, Chronically venous ulcer, Venous insufficiens
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 22 Mar 2012 (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.
Chronically venous ulcer in lower extremities is a permanent and disabling disease. Venous insufficience is the main cause of chronic ulcer. There is a high prevalence and frequency of the disease, primarily among elderly people. Recently, electromagnetic field therapy has been tested on various diseases in musculoskeletal system with a beneficial effect. In recent years, there has been an increasing interest in using electromagnetic field therapy to treat chronically venous ulcer.
The hypothesis of the investigators is that the electronic magnetic field therapy improves the healing process and reduces pain for patients suffering from chronically venous ulcer. The investigators assume that the bioactivity is affected by a cellular response which affects the DNA synthesis, transcription og protein synthesis.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronically venous ulcer | – | Device: Active Pulsed Electro-Magnetic Field (PEMF), Device: Placebo Pulsed Electro-Magnetic Field (PEMF)A group of 36 patients |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (4 listed)
- Patients who suffer from ulcer in lower extremities
- Patients who suffer from venous insufficience detected by duplex scanning or by a pressure on digits > 40 mmHg
- Patients with a regular need of compression stockings
- Age > 18 years
Key exclusion criteria (3 listed)
- Age < 18 years
- Unability to read or understand Danish
- Patients who suffer from manifest neoplastic disorder
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 |
|---|---|---|
| Active Pulsed Electro-Magnetic Field (PEMF)Also: No other names.One group of patients receive active devices. Both patients and investigator are blinded. | Device | Chronically venous ulcer |
| Placebo Pulsed Electro-Magnetic Field (PEMF)Also: No other names.One group of patients receive placebo devices. Both patients and investigator are blinded. | Device | Chronically venous ulcer |
Primary outcome
Reduction of ulcerous area.
Time frame: 3 months
Measurement of ulcerous area in order to assessing the effect of the healing process.
1 secondary outcome
Pain reduction in proportion to Visual Analogue Scale (VAS).
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2015.
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.
Vesal Khalid, M.D. study chair
Northern Orthopaedic Department, Aalborg University Hospital, Denmark
Nils Johannesen, M.D. study chair
Cardiology Department, Aalborg University Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Venous Hypertension With Ulcer and Inflammation and Venous Ulcer Pain, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 10 Apr 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 Denmark. 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?
Results are not available in the source record.
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?
Reduction of ulcerous area. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Apr 2015.