Electromagnetic Field Therapy to Improve Healing of Chronically Venous Ulcer

April 9, 2015 updated by: Northern Orthopaedic Division, Denmark

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark
        • Northern Orthopaedic Division, Aalborg University Hospital,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Primary care clinic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Chronically venous ulcer
A group of 36 patients
Device: Active Pulsed Electro-Magnetic Field (PEMF)
One group of patients receive active devices. Both patients and investigator are blinded.
Other Names:
  • No other names.
Device: Placebo Pulsed Electro-Magnetic Field (PEMF)
One group of patients receive placebo devices. Both patients and investigator are blinded.
Other Names:
  • No other names.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of ulcerous area.
Time Frame: 3 months
Measurement of ulcerous area in order to assessing the effect of the healing process.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain reduction in proportion to Visual Analogue Scale (VAS).
Time Frame: 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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northern Orthopaedic Division, Denmark

Investigators

  • Study Chair: Vesal Khalid, M.D., Northern Orthopaedic Department, Aalborg University Hospital, Denmark
  • Study Chair: Nils Johannesen, M.D., Cardiology Department, Aalborg University Hospital, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Anticipated)

June 1, 2015

Study Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

March 19, 2012

First Submitted That Met QC Criteria

March 21, 2012

First Posted (Estimate)

March 22, 2012

Study Record Updates

Last Update Posted (Estimate)

April 10, 2015

Last Update Submitted That Met QC Criteria

April 9, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-20110052

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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