Electromagnetic Field Therapy to Improve Healing of Chronically Venous Ulcer
|ClinicalTrials.gov Identifier: NCT01561170|
Recruitment Status : Unknown
Verified April 2015 by Northern Orthopaedic Division, Denmark.
Recruitment status was: Active, not recruiting
First Posted : March 22, 2012
Last Update Posted : April 10, 2015
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 or disease||Intervention/treatment||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)||Early Phase 1|
|Study Type :||Observational|
|Estimated Enrollment :||36 participants|
|Official Title:||The Effect of Electromagnetic Field Therapy to Improve Healing of Chronically Venous Ulcer in Lower Extremities|
|Study Start Date :||October 2011|
|Estimated Primary Completion Date :||June 2015|
|Estimated Study Completion Date :||June 2015|
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.
- Reduction of ulcerous area. [ Time Frame: 3 months ]Measurement of ulcerous area in order to assessing the effect of the healing process.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01561170
|Northern Orthopaedic Division, Aalborg University Hospital,|
|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|