Electromagnetic Field Therapy to Improve Healing of Chronically Venous Ulcer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2015-06-30

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.

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Detailed Description

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Conditions

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Chronic Venous Hypertension With Ulcer and Inflammation Venous Ulcer Pain

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Chronically venous ulcer

A group of 36 patients

Active Pulsed Electro-Magnetic Field (PEMF)

Intervention Type DEVICE

One group of patients receive active devices. Both patients and investigator are blinded.

Placebo Pulsed Electro-Magnetic Field (PEMF)

Intervention Type DEVICE

One group of patients receive placebo devices. Both patients and investigator are blinded.

Interventions

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Active Pulsed Electro-Magnetic Field (PEMF)

One group of patients receive active devices. Both patients and investigator are blinded.

Intervention Type DEVICE

Placebo Pulsed Electro-Magnetic Field (PEMF)

One group of patients receive placebo devices. Both patients and investigator are blinded.

Intervention Type DEVICE

Other Intervention Names

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No other names. No other names.

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