Monitoring Effect Of Shock Wave On Microcirculation Changes In Type2 Diabetes Mellitus

South Valley University

Status: Enrolling

Conditions: Shock Wave and Nitric Oxide

Treatments: Device: Low intensity extracorporeal shock wave

Study type: Interventional

Funder types: Other

Identifiers

NCT06159192

Shock wave and neuropathy

Details and patient eligibility

About

The purpose of the study is to monitor the effect of low intensity extracorporeal shock wave therapy on impaired nitric oxide synthase and microcirculation changes in type 2 diabetes mellitus with peripheral neuropathy.

Full description

Low-intensity extracorporeal shockwave therapy (Li-ESWT) improved peripheral nerve repair and regeneration. Li-ESWT exerts its biological effects by increasing neuro¬trophic factors, Schwann cell activation, and cellular signaling activation. Li-ESWT could be a novel treatment for nerve injury-induced diabetic neuropathy and other conditions related to nerve in¬jury.

Enrollment: 80 estimated patients

Sex: All

Ages: 40 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients have to be symptomatically stable with type 2 diabetes mellitus complicated with peripheral neuropathy.
• Optimized pharmacological treatment that will be remained unchanged throughout the study.

Exclusion criteria

• Implanted cardiac pacemakers.
• Patients with known skin allergies.
• Presence of skin inflammations.
• Peripheral vascular disease.
• Patients with unstable angina pectoris.
• Progressive ventricular dysrhythmia.
• Intermittent claudication.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Monitoring Effect Of Shock Wave On Microcirculation Changes In Type2 Diabetes Mellitus

Experimental group

Description:

Energy intensity of (0.09 mJ/mm2) for 12 treatment sessions, two per week, for six weeks

Treatment:

Device: Low intensity extracorporeal shock wave

Effect Of Shock Wave On Microcirculation Changes In Type2 Diabetes Mellitus

Experimental group

Description:

low intensity extracorporeal shock wave with the following parameters: - 3000 SWs (energy intensity of (0.09 mJ/mm2).

Treatment:

Device: Low intensity extracorporeal shock wave