Digital Heath Integration With Neuromodulation Therapies on Diabetic Neuropathy

Launched by CAIRO UNIVERSITY · Oct 31, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how digital health tools can work together with neuromodulation therapies to help people with diabetic neuropathy, a condition that causes nerve damage due to diabetes. The trial will include 60 patients aged 55 to 65 years, both men and women, who have been diagnosed with diabetic neuropathy. Participants will be randomly divided into two groups to see how these treatments affect their condition.

To be eligible, patients must have controlled diabetes and a body mass index (BMI) over 25. They also need to show signs of diabetic neuropathy based on specific screening criteria. However, people with certain health issues, such as severe cognitive impairment, other significant neurological disorders, or specific implanted medical devices, won't be able to participate. Those who join the trial can expect to follow certain study procedures and will need to provide informed consent, meaning they understand what the study involves and agree to participate. This trial aims to explore new ways to improve the quality of life for those affected by diabetic neuropathy.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Diagnosis of diabetes based on World Health Organization (WHO) with ages from 55to 65years 2. BMI\> 25kg/m2 3. Clinically diagnosed with diabetic neuropathy. 4. All patients are taking oral hypoglycemic drugs with controlled diabetes mellitus.
• • 5. Willingness to comply with the study procedures and interventions. 6. Ability to provide informed consent. 7. presenting with Distal symmetric polyneuropathy (DSPN) based on a score of ≥7 on the validated Michigan Neuropathy Screening Instrument (MNSI) questionnaire.
• • 8. exhibiting moderately controlled blood pressure
• Exclusion Criteria:
• • 1. Presence of other significant neurological or musculoskeletal disorders that may confound the assessment of outcomes.
• • 2. Severe cognitive impairment or inability to provide informed consent. 3. Any recent surgical procedures or major medical events that could affect the study outcomes.
• • 4. Fracture. 5. Heart Failure. 6. Uncooperative patients. 7. Anemic patient. 8. Patients with liver diseases. 9. Smokers Patients. 10. Any cardiac pacemaker, automatic implantable cardioverter defibrillator (AICD), or other implanted electrical device 11. An existing deep vein thrombosis (DVT) 12. Any metal implants 13. Current foot ulceration or other lower limb skin ulcers 14. Any other cause of neuropathy