Shock Wave and Nitric OxideNCT06159192
Monitoring Effect Of Shock Wave On Microcirculation Changes In Type2 Diabetes Mellitus
A study testing Low intensity extracorporeal shock wave in people with Shock Wave and Nitric Oxide, run by South Valley University at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Shock Wave and Nitric Oxide
- What is being tested?
- Low intensity extracorporeal shock wave
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Mar 2024to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
ibrahim ismail ibrahim abuzaid, PHD contact
Adbelrazak Ahmed Abdelrazak Ahmed, PHD contact
Egypt2 sites, 2 recruiting
- Recruiting
South Valley University
Luxor, South Valley University, South valley university
ibrahim ismail Abuzaid, PHD, +9620797756592 ext. +9620797756592, ibrahim_ismail_2011@svu.edu.eg
abdelrazak Ahmed Ahmed, PHD, +01063267068 ext. +201550732087, dr_abdelrazak_pt@yah00.com
- Recruiting
South Valley University
Luxor, South Valley University, South valley university
ibrahim ismail Abuzaid, PHD, +962797756592 ext. +962797756592, ibrahim_ismail_2011@svu.edu.eg
abdelrazak Ahmed abdelrazak ahmed, PHD, +01063267068 ext. +201550732087, dr_abdelrazak_pt@yahoo.com
About this study
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.
Read the 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.
- Conditions
- Shock Wave and Nitric Oxide
- Being tested
- Low intensity extracorporeal shock wave
- Keywords
- Shock Wave, Ntric oxide, Diabetes mellitus, Nerve conduction velocity
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low intensity extracorporeal shock waveDevice
Also called Shock wave
Extracorporeal shock wave therapy generator: Wonjin beauty SW10 shock wave therapy system made in Korean.
| Study group | Role | What they receive |
|---|---|---|
| Monitoring Effect Of Shock Wave On Microcirculation Changes In Type2 Diabetes Mellitus | Experimental | Energy intensity of (0.09 mJ/mm2) for 12 treatment sessions, two per week, for six weeks Receives: Device: Low intensity extracorporeal shock wave |
| Effect Of Shock Wave On Microcirculation Changes In Type2 Diabetes Mellitus | Experimental | low intensity extracorporeal shock wave with the following parameters: - 3000 SWs (energy intensity of (0.09 mJ/mm2). Receives: Device: Low intensity extracorporeal shock wave |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Nitric oxide level and electrophysiological investigations of peripheral nerves and muscles was measured pre and post treatment.
- 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.
Measured: six weeks
• Numerical Rating Pain Scale
- 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.
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start1 Mar 2024 (estimated)
- Primary completion25 Mar 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Shock Wave and Nitric OxideStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Abuzaid, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159192
- Sponsor's protocol ID
- Shock wave and neuropathy
- Status last verified
- Feb 2024
- First submitted
- 20 Nov 2023
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 18410351Cvijanovic 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.
PubMed 21545063
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Effect Of Shock Wave On Microcirculation Changes In Type2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06159192
- Acronym / sponsor ID
- Shock wave and neuropathy
- Conditions
- Shock Wave and Nitric Oxide
- Keywords
- Shock Wave, Ntric oxide, Diabetes mellitus, Nerve conduction velocity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 25 Mar 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 6 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Monitoring Effect Of Shock Wave On Microcirculation Changes In Type2 Diabetes Mellitus | Experimental | Device: Low intensity extracorporeal shock waveEnergy intensity of (0.09 mJ/mm2) for 12 treatment sessions, two per week, for six weeks |
| Effect Of Shock Wave On Microcirculation Changes In Type2 Diabetes Mellitus | Experimental | Device: Low intensity extracorporeal shock wavelow intensity extracorporeal shock wave with the following parameters: - 3000 SWs (energy intensity of (0.09 mJ/mm2). |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- Implanted cardiac pacemakers.
- Patients with known skin allergies.
- Presence of skin inflammations.
- Peripheral vascular disease.
- Patients with unstable angina pectoris.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low intensity extracorporeal shock waveAlso: Shock waveExtracorporeal shock wave therapy generator: Wonjin beauty SW10 shock wave therapy system made in Korean. | Device | Effect Of Shock Wave On Microcirculation Changes In Type2 Diabetes Mellitus, Monitoring Effect Of Shock Wave On Microcirculation Changes In Type2 Diabetes Mellitus |
Primary outcome
• 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.
• 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Background: PubMed 18410351Ovayolu 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.
- Background: PubMed 21545063Cvijanovic 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ibrahim ismail ibrahim abuzaid, PHD contact
Adbelrazak Ahmed Abdelrazak Ahmed, PHD contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low intensity extracorporeal shock wave in people with Shock Wave and Nitric Oxide, run by South Valley University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ibrahim ismail ibrahim abuzaid, PHD (+201006512150 ext. +962797756592, ibrahim_ismail_2011@svu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Nitric oxide level and electrophysiological investigations of peripheral nerves and muscles was measured pre and post treatment. (time frame: six weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06159192, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.