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

Not Applicable

Recruiting

• Conditions: Shock Wave and Nitric Oxide
• Interventions: Device: Low intensity extracorporeal shock wave

• Registration Number: NCT06159192
• Lead Sponsor: South Valley University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-11-20
• Study First Submitted QC: 2023-11-28
• Study First Posted: 2023-12-06
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-23
• Last Update Posted: 2024-02-26
• Study Start: 2024-03-01
• Primary Completion: 2024-03-25
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Effect Of Shock Wave On Microcirculation Changes In Type2 Diabetes Mellitus	Low intensity extracorporeal shock wave	low intensity extracorporeal shock wave with the following parameters: - 3000 SWs (energy intensity of (0.09 mJ/mm2).
Monitoring Effect Of Shock Wave On Microcirculation Changes In Type2 Diabetes Mellitus	Low intensity extracorporeal shock wave	Energy intensity of (0.09 mJ/mm2) for 12 treatment sessions, two per week, for six weeks

Primary Outcome Measures

Name	Time	Method
• Numerical Rating Pain Scale	six weeks	• The Numerical Rating Scale (NRS) is designed for anyone over age 9. It is one of the most commonly used pain scales in health care. To use it, you just say the number that best matches the level of pain you are feeling; you can also place a mark on the scale itself. Zero means you have no pain, while 10 represents the most intense pain possible.
• Nitric oxide level and electrophysiological investigations of peripheral nerves and muscles was measured pre and post treatment.	six weeks	1. Laboratory methods: Nitric oxide laboratories for measurement of nitric oxide level.3. Electrodiagnostic studies are sensitive, specific, and validated measures of the presence of polyneuropathy.

Trial Locations

Locations (1)

South Valley University; 🇪🇬 Luxor, South Valley University, Egypt