CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 28 enrolled
Drug / intervention
I-Onedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05922618
NCT05922618N/ACompleted
CompareCT.gov

PEMFS in Patients With CRPS-I of the Foot and Ankle: a Randomized Controlled Trial

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari·interventional·Posted Jun 28, 2023·Updated May 15, 2026

In Brief

A clinical study evaluating I-One for Pain, Joint and 3 related conditions. Completed, enrolled 28 participants across 1 site.

Detailed Summary

The investigators hypothesize that the association of I-ONE® therapy with standard rehabilitation treatment can optimize the clinical and functional recovery of patients with pulsed electromagnetic fields (PEMFs) (I-ONE® therapy) of the foot or ankle.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Joint, Complex Regional Pain Syndromes, Ankle Disease, Foot Diseases
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedJun 28, 2023
Enrollment StartAug 1, 2023
Primary CompletionAug 1, 2025
Study CompletionDec 1, 2025
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 3.0 years ago

Interventions

I-Onedevice

I-ONE® is a medical device certified by the Ministry of Health as a Medical Device (risk class II A) for the treatment of inflammatory and degenerative tissue pathologies. The device consists of a signal generator and an applicator, called a solenoid. The solenoid will be placed on the joint, not necessarily in direct contact with the skin. The device works with a rechargeable battery and is equipped with an hour counter to assess patient compliance. Treatment with I-ONE® therapy will start within 3-7 days of recruitment, will last 6 hours a day and will be maintained for 60 days. The treatment will be carried out at home and the device will be delivered directly to the patient's home by courier.