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

NCT ID: NCT06159192

Last Updated: 2024-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2024-04-01

Brief Summary

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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

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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.

Conditions

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Shock Wave and Nitric Oxide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
A group of 80 patients (male and female) diagnosed as type 2 diabetes mellitus, will be included in the study. Their age will be ranged from 40-60 years. Their weight ranged from 80 - 100 k.g. and their height ranged from 160 - 180 cm. Patients will divide into two groups: Study groups (A) 40 patients type 2 diabetes mellitus with clinically proved peripheral neuropathy. And control group (B) 40 patients with asymptomatic type 2 diabetes mellitus. They will be selected from South valley university hospitals. Group A will receive low intensity extracorporeal shock wave therapy for two per week for four weeks. Group B will receive shame low intensity extracorporeal shock wave therapy.

Study Groups

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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

Group Type EXPERIMENTAL

Low intensity extracorporeal shock wave

Intervention Type DEVICE

Extracorporeal shock wave therapy generator: Wonjin beauty SW10 shock wave therapy system made in Korean.

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).

Group Type EXPERIMENTAL

Low intensity extracorporeal shock wave

Intervention Type DEVICE

Extracorporeal shock wave therapy generator: Wonjin beauty SW10 shock wave therapy system made in Korean.

Interventions

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Low intensity extracorporeal shock wave

Extracorporeal shock wave therapy generator: Wonjin beauty SW10 shock wave therapy system made in Korean.

Intervention Type DEVICE

Other Intervention Names

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Shock wave

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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South Valley University

OTHER

Sponsor Role lead

Responsible Party

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Ibrahim Abuzaid

Head of the Department of Physiotherapy for Cardiovascular/ Rspiratory disorder and Geriatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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South Valley University

Luxor, South Valley University, Egypt

Site Status RECRUITING

South Valley University

Luxor, South Valley University, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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ibrahim ismail ibrahim abuzaid, PHD

Role: CONTACT

+201006512150 ext. +962797756592

Adbelrazak Ahmed Abdelrazak Ahmed, PHD

Role: CONTACT

+01063267068 ext. +215507322087

Facility Contacts

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ibrahim ismail Abuzaid, PHD

Role: primary

+9620797756592 ext. +9620797756592

abdelrazak Ahmed Ahmed, PHD

Role: backup

+01063267068 ext. +201550732087

ibrahim ismail Abuzaid, PHD

Role: primary

+962797756592 ext. +962797756592

abdelrazak Ahmed abdelrazak ahmed, PHD

Role: backup

+01063267068 ext. +201550732087

References

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Ovayolu N, Akarsu E, Madenci E, Torun S, Ucan O, Yilmaz M. Clinical characteristics of patients with diabetic polyneuropathy: the role of clinical and electromyographic evaluation and the effect of the various types on the quality of life. Int J Clin Pract. 2008 Jul;62(7):1019-25. doi: 10.1111/j.1742-1241.2008.01730.x. Epub 2008 Apr 10.

Reference Type BACKGROUND
PMID: 18410351 (View on PubMed)

Cvijanovic M, Ilin M, Slankamenac P, Horvat SB, Jovin Z. The sensitivity of electromyoneurography in the diagnosis of diabetic polyneuropathy. Med Pregl. 2011 Jan-Feb;64(1-2):11-4. doi: 10.2298/mpns1102011c.

Reference Type BACKGROUND
PMID: 21545063 (View on PubMed)

Other Identifiers

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Shock wave and neuropathy

Identifier Type: -

Identifier Source: org_study_id

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