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

February 23, 2024 updated by: Ibrahim Abuzaid, South Valley University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • South Valley University
      • Luxor, South Valley University, Egypt, South valley university
        • Recruiting
        • South Valley University
        • Contact:
        • Contact:
        • Principal Investigator:
          • ibrahim ismail ibrahim abuzaid, PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Monitoring Effect Of Shock Wave On Microcirculation Changes In Type2 Diabetes Mellitus
Energy intensity of (0.09 mJ/mm2) for 12 treatment sessions, two per week, for six weeks
Device: Low intensity extracorporeal shock wave
Extracorporeal shock wave therapy generator: Wonjin beauty SW10 shock wave therapy system made in Korean.
Other Names:
  • Shock wave
Experimental: Effect Of Shock Wave On Microcirculation Changes In Type2 Diabetes Mellitus
low intensity extracorporeal shock wave with the following parameters: - 3000 SWs (energy intensity of (0.09 mJ/mm2).
Device: Low intensity extracorporeal shock wave
Extracorporeal shock wave therapy generator: Wonjin beauty SW10 shock wave therapy system made in Korean.
Other Names:
  • Shock wave

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
• Nitric oxide level and electrophysiological investigations of peripheral nerves and muscles was measured pre and post treatment.
Time Frame: 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.
six weeks
• Numerical Rating Pain Scale
Time Frame: 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.
six weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Valley University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

March 25, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

November 20, 2023

First Submitted That Met QC Criteria

November 28, 2023

First Posted (Actual)

December 6, 2023

Study Record Updates

Last Update Posted (Estimated)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Shock wave and neuropathy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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