Electromagnetic Field Therapy to Improve Healing of Chronically Venous Ulcer

Chronic Venous Hypertension With Ulcer and Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01561170
• Other study ID #: N-20110052
• Status: Active, not recruiting
• Phase: Phase 0
• First received: March 19, 2012
• Last updated: April 9, 2015
• Start date: October 2011
• Est. completion date: June 2015

Study information

• Verified date: April 2015
• Source: Northern Orthopaedic Division, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Chronic Venous Hypertension With Ulcer and Inflammation
• Inflammation
• Ulcer
• Varicose Ulcer
• Venous Ulcer Pain

Intervention

Device:
• Active Pulsed Electro-Magnetic Field (PEMF)
One group of patients receive active devices. Both patients and investigator are blinded.
• Placebo Pulsed Electro-Magnetic Field (PEMF)
One group of patients receive placebo devices. Both patients and investigator are blinded.

Locations

Country	Name	City	State
Denmark	Northern Orthopaedic Division, Aalborg University Hospital,	Aalborg

Sponsors (1)

Lead Sponsor	Collaborator
Northern Orthopaedic Division, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of ulcerous area.	Measurement of ulcerous area in order to assessing the effect of the healing process.	3 months	No
Secondary	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	No