This trial is active, not recruiting.

Conditions chronic venous hypertension with ulcer and inflammation, venous ulcer pain
Treatments active pulsed electro-magnetic field (pemf), placebo pulsed electro-magnetic field (pemf)
Phase phase 0
Sponsor Northern Orthopaedic Division, Denmark
Start date October 2011
End date June 2015
Trial size 36 participants
Trial identifier NCT01561170, N-20110052


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective retrospective
A group of 36 patients
active pulsed electro-magnetic field (pemf) No other names.
One group of patients receive active devices. Both patients and investigator are blinded.
placebo pulsed electro-magnetic field (pemf) No other names.
One group of patients receive placebo devices. Both patients and investigator are blinded.

Primary Outcomes

Reduction of ulcerous area.
time frame: 3 months

Secondary Outcomes

Pain reduction in proportion to Visual Analogue Scale (VAS).
time frame: 3 months

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

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

Additional Information

Official title The Effect of Electromagnetic Field Therapy to Improve Healing of Chronically Venous Ulcer in Lower Extremities
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Northern Orthopaedic Division, Denmark.