Chronic Venous Hypertension With Ulcer and Inflammation, Venous Ulcer Pain
Conditions
Keywords
Electromagnetic, Field therapy, Chronically venous ulcer, Venous insufficiens
Brief 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. 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.
Interventions
One group of patients receive active devices. Both patients and investigator are blinded.
One group of patients receive placebo devices. Both patients and investigator are blinded.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of ulcerous area. | 3 months | Measurement of ulcerous area in order to assessing the effect of the healing process. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain reduction in proportion to Visual Analogue Scale (VAS). | 3 months | 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. |
Countries
Denmark