Electromagnetic Field Therapy to Improve Healing of Chronically Venous Ulcer

• Conditions: Venous Ulcer Pain; Chronic Venous Hypertension With Ulcer and Inflammation
• Interventions: Device: Active Pulsed Electro-Magnetic Field (PEMF); Device: Placebo Pulsed Electro-Magnetic Field (PEMF)

• Registration Number: NCT01561170
• Lead Sponsor: Northern Orthopaedic Division, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-03-19
• Study First Submitted QC: 2012-03-21
• Study First Posted: 2012-03-22
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-09
• Last Update Posted: 2015-04-10
• Primary Completion: 2015-06
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronically venous ulcer	Active Pulsed Electro-Magnetic Field (PEMF)	A group of 36 patients
Chronically venous ulcer	Placebo Pulsed Electro-Magnetic Field (PEMF)	A group of 36 patients

Primary Outcome Measures

Name	Time	Method
Reduction of ulcerous area.	3 months	Measurement of ulcerous area in order to assessing the effect of the healing process.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Northern Orthopaedic Division, Aalborg University Hospital,; 🇩🇰 Aalborg, Denmark