EMF Therapy and Custom Foot Insoles for Diabetic Foot Ulcers
Electromagnetic Field Therapy: • Frequency: 50 Hz • Intensity: 5-30 mT • Duration: 30 minutes/session • Frequency: 3 sessions/week for 8 weeks Customized Foot Insoles: • Individually tailored based on
Cardiovascular Diseases+13
+ Diabetes Mellitus
+ Diabetic Angiopathies
Treatment Study
Summary
Study start date: August 1, 2025
Actual date on which the first participant was enrolled.This study explores a new treatment approach for people with diabetic foot ulcers. The main goal is to see if using EMF therapy combined with specially designed foot insoles can help improve blood flow in the legs of these patients. Diabetic foot ulcers are a common problem for people with diabetes, often leading to complications if not properly managed. By improving circulation, this study aims to enhance healing and reduce pain, which could lead to better outcomes for patients and potentially offer an alternative to standard care methods. Participants in this study will receive EMF therapy along with customized foot insoles. The study will measure if this combination improves the blood flow in their legs, using a test called the Ankle-Brachial Pressure Index (ABPI). Researchers will compare the healing rates of ulcers and the level of pain experienced by participants using this new treatment against those who receive standard care. The results will help determine the effectiveness and potential benefits of this innovative treatment approach for diabetic foot ulcers.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.79 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 40 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * • Diagnosed with Type 2 Diabetes Mellitus. * Presence of unilateral or bilateral diabetic foot ulcer. * ABPI between 0.6 - 1.0 (mild to moderate arterial insufficiency). Exclusion Criteria: * • Severe peripheral arterial disease (ABPI \<0.5). * Active infection requiring hospitalization. * History of amputation. * Cardiac pacemaker or contraindication to EMF therapy.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
PlaceboGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives