Electromagnetic Stimulation (FREMS) in Patients With Painful Diabetic Neuropathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2004-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

We postulate that frequency-modulated electromagnetic stimulation (FREMS) may decrease pain in patients with painful diabetic neuropathy.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The stuy was designed as a randomized, double-blind, placebo-controlled cross-over trial. Each patient received two series of ten treatments of either FREMS or placebo in random sequence, with each series lasting no more than three weeks. Primary outcomes (daytime and night-time pain scores) an secondary outcomes (Motor and sensory nerve conduction velocity, sensory tactile perception, foot vibration perception threshold, quality of life, cutaneous microvascular flow, partial tissue tension of oxygen and carbon dioxide) were measured at baseline, after FREMS/placebo series and after 4 months follow-up.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Painful Diabetic Neuropathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Frequency-modulated electromagnetic neural stimulation

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* type 1 or type 2 diabetes (American Diabetes Association criteria)
* painful diabetic neuropathy with reduced sensory/motor nerve conduction velocity (i.e., \<40 m/sec in at least one nerve trunk of the lower limbs)
* vibration perception at the big toe \>25 V

Exclusion Criteria

* presence of any concomitant severe disease
* pregnancy
* renal disease (serum creatinine \>2.0 mg/dL)
* history or current foot ulcer
* lower limb arterial disease (ankle-brachial index \<0.9) or transcutaneous partial pressure of oxygen \<50 mmHg)

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Emanuele Bosi, MD

Role: PRINCIPAL_INVESTIGATOR

San Raffaele Scientific Institute and Vita-Salute San Raffaele University, Milano (Italy)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

San Raffaele Hospital and Scientific Institute

Milan, (Mi), Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

References

Explore related publications, articles, or registry entries linked to this study.

Bosi E, Conti M, Vermigli C, Cazzetta G, Peretti E, Cordoni MC, Galimberti G, Scionti L. Effectiveness of frequency-modulated electromagnetic neural stimulation in the treatment of painful diabetic neuropathy. Diabetologia. 2005 May;48(5):817-23. doi: 10.1007/s00125-005-1734-2. Epub 2005 Apr 15.

Reference Type RESULT

PMID: 15834546 (View on PubMed)

Conti M, Peretti E, Cazzetta G, Galimberti G, Vermigli C, Pola R, Scionti L, Bosi E. Frequency-modulated electromagnetic neural stimulation enhances cutaneous microvascular flow in patients with diabetic neuropathy. J Diabetes Complications. 2009 Jan-Feb;23(1):46-8. doi: 10.1016/j.jdiacomp.2008.02.004. Epub 2008 Apr 10.

Reference Type DERIVED

PMID: 18403219 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LORENZ/01

Identifier Type: -

Identifier Source: org_study_id