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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronically venous ulcer | A group of 36 patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Pulsed Electro-Magnetic Field (PEMF) | Device | One group of patients receive active devices. Both patients and investigator are blinded. |
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| Measure | Description | Time Frame |
|---|---|---|
| Reduction of ulcerous area. | Measurement of ulcerous area in order to assessing the effect of the healing process. | 3 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Primary care clinic
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| Name | Affiliation | Role |
|---|---|---|
| Vesal Khalid, M.D. | Northern Orthopaedic Department, Aalborg University Hospital, Denmark | Study Chair |
| Nils Johannesen, M.D. | Cardiology Department, Aalborg University Hospital, Denmark | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northern Orthopaedic Division, Aalborg University Hospital, | Aalborg | Denmark |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo Pulsed Electro-Magnetic Field (PEMF) | Device | One group of patients receive placebo devices. Both patients and investigator are blinded. |
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