Electromagnetic Field Therapy to Improve Healing of Chronically Venous Ulcer

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Electromagnetic Field Therapy to Improve Healing of Chronically Venous Ulcer in Lower Extremities

Conditions
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Chronic Venous Hypertension With Ulcer and Inflammation, Venous Ulcer Pain

Intervention / Treatment
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* Device: Active Pulsed Electro-Magnetic Field (PEMF)
* Device: Placebo Pulsed Electro-Magnetic Field (PEMF)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Age < 18 years Unability to read or understand Danish Patients who suffer from manifest neoplastic disorder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronically venous ulcer<br>A group of 36 patients | Device: Active Pulsed Electro-Magnetic Field (PEMF)<br>* One group of patients receive active devices. Both patients and investigator are blinded.<br>* Other names: No other names.;Device: Placebo Pulsed Electro-Magnetic Field (PEMF)<br>* One group of patients receive placebo devices. Both patients and investigator are blinded.<br>* Other names: No other names.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of ulcerous area. | Measurement of ulcerous area in order to assessing the effect of the healing process. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electromagnetic, Field therapy, Chronically venous ulcer, Venous insufficiens