Acetylcholine Iontophoresis As A New Challenge With Type 2 Diabetic Peripheral Neuropathy: A Possible New Therapy
NCT ID: NCT06219590
Last Updated: 2024-01-23
Study Results
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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RECRUITING
NA
80 participants
INTERVENTIONAL
2023-10-28
2024-01-30
Brief Summary
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Detailed Description
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Material and methods:
A group of 80 patients (male and female) diagnosed as type 2 diabetes mellitus, will be included in the study their age ranged from 40-60 years. Patients randomly will be divided 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 were selected from south valley university hospitals. Group (A) receive iontophoresis by acetylcholine with (15) min for three sessions per week for four weeks. Also the investigators followed up study group (A) one month of aerobic exercises in form of 15 minute walking, bicycling, or swimming, and the investigators reevaluated nitric oxide level. Group (B) received shame iontophoresis with (15) min for three sessions per week for four weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Study group (A)
* 40 patients with type 2 diabetes mellitus clinically proved peripheral neuropathy.
* Both groups were received conventional medical treatment and healthy diet.
* Group A was received iontophoresis by acetylcholine with (15) min for three sessions per week for four weeks.
Acetylcholine Iontophoresis
Acetylcholine Iontophoresis 15 min/ three sessions/ week for two weeks.
Control group (B)
* 40 patients with asymptomatic type 2 diabetes mellitus, both groups were selected from south valley university hospitals.
* Both groups were received conventional medical treatment and healthy diet.
* Group (B) was received shame iontophoresis with (15) min for three sessions per week for four weeks.
Shame Acetylcholine Iontophoresis
Shame Acetylcholine Iontophoresis 15 min/ three sessions/ week for two weeks.
Interventions
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Acetylcholine Iontophoresis
Acetylcholine Iontophoresis 15 min/ three sessions/ week for two weeks.
Shame Acetylcholine Iontophoresis
Shame Acetylcholine Iontophoresis 15 min/ three sessions/ week for two weeks.
Eligibility Criteria
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Inclusion Criteria
* Optimized pharmacological treatment that will be remained unchanged throughout the study.
Exclusion Criteria
* Patients with known skin allergies.
* Presence of skin inflammations.
* Peripheral vascular disease.
40 Years
60 Years
ALL
No
Sponsors
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South Valley University
OTHER
Responsible Party
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Reham Abdelrazek Mohamed Ellisy
Principal investigator.
Locations
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Faculty of Physical Therapy, South Valley University
Qina, , Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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Abularrage CJ, Sidawy AN, Aidinian G, Singh N, Weiswasser JM, Arora S. Evaluation of the microcirculation in vascular disease. J Vasc Surg. 2005 Sep;42(3):574-81. doi: 10.1016/j.jvs.2005.05.019.
Alzahrani SH, Ajjan RA. Coagulation and fibrinolysis in diabetes. Diab Vasc Dis Res. 2010 Oct;7(4):260-73. doi: 10.1177/1479164110383723. Epub 2010 Sep 16.
Goyal M, Kumar A, Mahajan N, Moitra M. 2013: Treatment of plantar fasciitis by taping vs. iontophoresis: a randomized clinical trial. J Exercise Sci Physiother; 9:34-39.
Barwick AL, Tessier JW, Janse de Jonge X, Ivers JR, Chuter VH. Peripheral sensory neuropathy is associated with altered postocclusive reactive hyperemia in the diabetic foot. BMJ Open Diabetes Res Care. 2016 Jul 7;4(1):e000235. doi: 10.1136/bmjdrc-2016-000235. eCollection 2016.
Other Identifiers
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Ach Iontophoresis neuropathy
Identifier Type: -
Identifier Source: org_study_id
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