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Electromagnetic Field Therapy to Improve Healing of Chronically Venous Ulcer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier:
NCT01561170
First received: March 19, 2012
Last updated: May 1, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Venous Hypertension With Ulcer and Inflammation
Venous Ulcer Pain
 Device: Active Pulsed Electro-Magnetic Field (PEMF)
Device: Placebo Pulsed Electro-Magnetic Field (PEMF)
 Phase 0

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: The Effect of Electromagnetic Field Therapy to Improve Healing of Chronically Venous Ulcer in Lower Extremities

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Northern Orthopaedic Division, Denmark:

Primary Outcome Measures:
  • Reduction of area of ulcer. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Measurement of the area of ulcer in order to assessing the effect of the healing process.


Secondary Outcome Measures:
  • Pain reduction in proportion to Visual Analogue Scale (VAS). [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 36
Study Start Date: October 2011
Study Completion Date: April 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: No other names.
Device: Placebo Pulsed Electro-Magnetic Field (PEMF)
One group of patients receive placebo devices. Both patients and investigator are blinded.
Other Name: No other names.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Primary care clinic

Criteria

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
  • Patients who do not read or understand Danish
  • Patients who suffer from manifest neoplastic disorder
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01561170

Locations
Denmark
Northern Orthopaedic Division, Aalborg University Hospital,
Aalborg, Denmark
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier: NCT01561170     History of Changes
Other Study ID Numbers: N-20110052
Study First Received: March 19, 2012
Last Updated: May 1, 2013
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: The Danish Dataprotection Agency.

Keywords provided by Northern Orthopaedic Division, Denmark:
Electromagnetic
Field therapy
Chronically venous ulcer
Venous insufficiens

Additional relevant MeSH terms:
Hypertension
Inflammation
Ulcer
Varicose Ulcer
Vascular Diseases
Cardiovascular Diseases
 Pathologic Processes
Varicose Veins
Leg Ulcer
Skin Ulcer
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013