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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01561170
Enrollment
36
Registered
2012-03-22
Start date
2011-10-31
Completion date
2015-06-30
Last updated
2015-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Venous Hypertension With Ulcer and Inflammation, Venous Ulcer Pain

Keywords

Electromagnetic, Field therapy, Chronically venous ulcer, Venous insufficiens

Brief summary

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.

Interventions

DEVICEActive Pulsed Electro-Magnetic Field (PEMF)

One group of patients receive active devices. Both patients and investigator are blinded.

DEVICEPlacebo Pulsed Electro-Magnetic Field (PEMF)

One group of patients receive placebo devices. Both patients and investigator are blinded.

Sponsors

Northern Orthopaedic Division, Denmark
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Reduction of ulcerous area.3 monthsMeasurement of ulcerous area in order to assessing the effect of the healing process.

Secondary

MeasureTime frameDescription
Pain reduction in proportion to Visual Analogue Scale (VAS).3 monthsThe 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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026