Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Electromagnetic Field Therapy to Improve Healing of Chronically Venous Ulcer

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Northern Orthopaedic Division, Denmark
Sponsor:
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier:
NCT01561170
First received: March 19, 2012
Last updated: June 17, 2014
Last verified: June 2014

March 19, 2012
June 17, 2014
October 2011
June 2015   (final data collection date for primary outcome measure)
Reduction of ulcerous area. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Measurement of ulcerous area in order to assessing the effect of the healing process.
Reduction of area of ulcer. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Measurement of the area of ulcer in order to assess the effect of the healing process.
Complete list of historical versions of study NCT01561170 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Electromagnetic Field Therapy to Improve Healing of Chronically Venous Ulcer
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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
Not Provided
Probability Sample

Primary care clinic

  • Chronic Venous Hypertension With Ulcer and Inflammation
  • Venous Ulcer Pain
  • 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.
Chronically venous ulcer
A group of 36 patients
Interventions:
  • Device: Active Pulsed Electro-Magnetic Field (PEMF)
  • Device: Placebo Pulsed Electro-Magnetic Field (PEMF)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
36
June 2015
June 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact: Sten Rasmussen, M.D. sten.rasmussen@rn.dk
Contact: Vesal Khalid, Med.student vekh@rn.dk
Denmark
 
NCT01561170
N-20110052
No
Northern Orthopaedic Division, Denmark
Northern Orthopaedic Division, Denmark
Not Provided
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
Northern Orthopaedic Division, Denmark
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP