Diabetic NephropathyNCT06482021
Comparative Effectiveness Of Low Extra-Corporeal Shock Wave Versus Acetylcholine Iontophoresis On Type2 Diabetic Neuropathy
A study testing Low-intensity extracorporeal shock wave in people with Diabetic Nephropathy, run by South Valley University.
Trial summary
In our thesis, we will compare the effectiveness of low-intensity shock wave versus acetylcholine iontophoresis as a possible new therapy for microcirculation changes in type 2 diabetic neuropathy Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Nephropathy
- 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
- No sites listed yet
- Study dates
- 10 Jul 2024to 1 Oct 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.
About this study
Official title: Comparative Effectiveness Of Low Extra-Corporeal Shock Wave Versus Acetylcholine Iontophoresis On Type2 Diabetic Neuropathy: Randomized Clinical Trial
In our thesis, we will compare the effectiveness of low-intensity shock wave versus acetylcholine iontophoresis as a possible new therapy for microcirculation changes in type 2 diabetic neuropathy
Read the detailed description
Methods: A group of 80 patients (male and female) diagnosed with type 2 diabetes mellitus, was included in the study. Their age ranged from 40-60 years. Patients randomly will be divided into two groups: Study groups (A) 40 patients with type 2 diabetes mellitus with clinically proven peripheral neuropathy. And study group (B) 40 patients with type 2 diabetes mellitus with clinically proven peripheral neuropathy. They were selected from South Valley University Hospitals. Group A received low-intensity extracorporeal shock wave therapy Li-ESWT (3 Hz, 0.09 mJ/mm2, 300 pulses), for two sessions per week for six weeks. Study group (B) received iontophoresis by acetylcholine current intensity of 3 to 5 mA. Check skin every 3-5 minutes for signs of skin irritation with (15) min for three sessions per week for four weeks. Nitric oxide level and the electrophysiology (EMG) of peripheral nerves and muscles were measured pre and post-treatment.
- Conditions
- Diabetic Nephropathy
- Being tested
- Low-intensity extracorporeal shock wave
- Keywords
- Acetylcholine iontophoresis, shockwave
- Medical subject headings
- Diabetic Nephropathies
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 Device, ASTAR Swit 33, 43-382 dual-channel Stimulator (Bielsko-Biata, Poland) 230V-, 50/60 HZ, max 70 W, 100VA, was used.
Acetylcholine iontophoresis• The Iontophoresis comprises of electric impulses from a low voltage galvanic current stimulation unit to drive ions (Ach) (1%) into soft tissue structures.
| Study group | Role | What they receive |
|---|---|---|
| Study group (A) Low-intensity shock wave group | Experimental | Study group A will receive low-intensity extracorporeal shock wave therapy Li-ESWT (3 Hz, 0.09 mJ/mm2, 300 pulses), for two sessions per week for six weeks. Nitric oxide level and the electrophysiology (EMG) of peripheral nerves and muscles were measured pre and post-treatment. Receives: Device: Low-intensity extracorporeal shock wave |
| Study group (B) Acetylcholine iontophoresis group | Experimental | Study group (B) will receive iontophoresis by acetylcholine current intensity of 3 to 5 mA. Check skin every 3-5 minutes for signs of skin irritation with (15) min for three sessions per week for six weeks. Nitric oxide level and the electrophysiology (EMG) of peripheral nerves and muscles were measured pre and post-treatment. Receives: Device: Low-intensity extracorporeal shock wave |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrophysiological investigations of peripheral nerves (latency, amplitude and velocity of peripheral nerves)
Electrophysiological investigations of peripheral nerves were measured pre and post treatment for both groups (latency, amplitude and velocity of peripheral nerves)
Measured: Six weeks
Secondary outcomes (1)
Nitric oxide laboratories for measurement of nitric oxide level
Nitric oxide laboratories for measurement of nitric oxide level were measured pre and post treatment for both groups.
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 posted1 Jul 2024
- Study start10 Jul 2024 (estimated)
- Primary completion10 Sep 2024 (estimated)
- Study completion1 Oct 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 Diabetic NephropathyStudies 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
- the study will be designed to compare the effect of extracorporeal shock wave therapy and acetylcholine iontophoresis on microcirculation changes as a possible new therapy for type 2 diabetic 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
- NCT06482021
- Sponsor's protocol ID
- Comparative Study
- Status last verified
- Jun 2024
- First submitted
- 8 Jun 2024
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After publication
Publications
Chen KT, Chen YP, Kuo YJ, Chiang MH. Extracorporeal Shock Wave Therapy Provides Limited Therapeutic Effects on Carpal Tunnel Syndrome: A Systematic Review and Meta-Analysis. Medicina (Kaunas). 2022 May 19;58(5):677. doi: 10.3390/medicina58050677.
PubMed 35630095Melese H, Alamer A, Getie K, Nigussie F, Ayhualem S. Extracorporeal shock wave therapy on pain and foot functions in subjects with chronic plantar fasciitis: systematic review of randomized controlled trials. Disabil Rehabil. 2022 Sep;44(18):5007-5014. doi: 10.1080/09638288.2021.1928775. Epub 2021 May 26.
PubMed 34038642
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness Of Low Extra-Corporeal Shock Wave Versus Acetylcholine Iontophoresis On Type2 Diabetic Neuropathy: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06482021
- Acronym / sponsor ID
- Comparative Study
- Conditions
- Diabetic Nephropathy
- Keywords
- Acetylcholine iontophoresis, shockwave
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 10 Jul 2024 (estimated)
- Primary completion
- 10 Sep 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 1 Jul 2024 (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.
In our thesis, we will compare the effectiveness of low-intensity shock wave versus acetylcholine iontophoresis as a possible new therapy for microcirculation changes in type 2 diabetic neuropathy
Detailed description
Methods: A group of 80 patients (male and female) diagnosed with type 2 diabetes mellitus, was included in the study. Their age ranged from 40-60 years. Patients randomly will be divided into two groups: Study groups (A) 40 patients with type 2 diabetes mellitus with clinically proven peripheral neuropathy. And study group (B) 40 patients with type 2 diabetes mellitus with clinically proven peripheral neuropathy. They were selected from South Valley University Hospitals. Group A received low-intensity extracorporeal shock wave therapy Li-ESWT (3 Hz, 0.09 mJ/mm2, 300 pulses), for two sessions per week for six weeks. Study group (B) received iontophoresis by acetylcholine current intensity of 3 to 5 mA. Check skin every 3-5 minutes for signs of skin irritation with (15) min for three sessions per week for four weeks. Nitric oxide level and the electrophysiology (EMG) of peripheral nerves and muscles were measured pre and post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- the study will be designed to compare the effect of extracorporeal shock wave therapy and acetylcholine iontophoresis on microcirculation changes as a possible new therapy for type 2 diabetic peripheral neuropathy.
| Arm | Type | Receives |
|---|---|---|
| Study group (A) Low-intensity shock wave group | Experimental | Device: Low-intensity extracorporeal shock waveStudy group A will receive low-intensity extracorporeal shock wave therapy Li-ESWT (3 Hz, 0.09 mJ/mm2, 300 pulses), for two sessions per week for six weeks. Nitric oxide level and the electrophysiology (EMG) of peripheral nerves and muscles were measured pre and post-treatment. |
| Study group (B) Acetylcholine iontophoresis group | Experimental | Device: Low-intensity extracorporeal shock waveStudy group (B) will receive iontophoresis by acetylcholine current intensity of 3 to 5 mA. Check skin every 3-5 minutes for signs of skin irritation with (15) min for three sessions per week for six weeks. Nitric oxide level and the electrophysiology (EMG) of peripheral nerves and muscles were measured pre and post-treatment. |
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: Device, ASTAR Swit 33, 43-382 dual-channel Stimulator (Bielsko-Biata, Poland) 230V-, 50/60 HZ, max 70 W, 100VA, was used.Acetylcholine iontophoresis• The Iontophoresis comprises of electric impulses from a low voltage galvanic current stimulation unit to drive ions (Ach) (1%) into soft tissue structures. | Device | Study group (A) Low-intensity shock wave group, Study group (B) Acetylcholine iontophoresis group |
Primary outcome
Electrophysiological investigations of peripheral nerves (latency, amplitude and velocity of peripheral nerves)
Time frame: Six weeks
Electrophysiological investigations of peripheral nerves were measured pre and post treatment for both groups (latency, amplitude and velocity of peripheral nerves)
1 secondary outcome
Nitric oxide laboratories for measurement of nitric oxide level
Time frame: Six weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Results publication: PubMed 35630095Chen KT, Chen YP, Kuo YJ, Chiang MH. Extracorporeal Shock Wave Therapy Provides Limited Therapeutic Effects on Carpal Tunnel Syndrome: A Systematic Review and Meta-Analysis. Medicina (Kaunas). 2022 May 19;58(5):677. doi: 10.3390/medicina58050677.
- Results publication: PubMed 34038642Melese H, Alamer A, Getie K, Nigussie F, Ayhualem S. Extracorporeal shock wave therapy on pain and foot functions in subjects with chronic plantar fasciitis: systematic review of randomized controlled trials. Disabil Rehabil. 2022 Sep;44(18):5007-5014. doi: 10.1080/09638288.2021.1928775. Epub 2021 May 26.
- Individual participant dataSharing planned: Undecided. After publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Low-intensity extracorporeal shock wave in people with Diabetic Nephropathy, run by South Valley University.
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 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electrophysiological investigations of peripheral nerves (latency, amplitude and velocity of peripheral nerves) (time frame: Six weeks). 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 NCT06482021, 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 1 Jul 2024.