Acetylcholine Iontophoresis As A New Challenge With Type 2 Diabetic Peripheral Neuropathy: A Possible New Therapy
1 other identifier
interventional
80
1 country
1
Brief Summary
The investigators initial study opened the way for randomized trials that monitor the effects of acetylcholine (Ach) iontophoresis vasodilators on endothelial nitric oxide synthetase (NOS) to develop a transdermal treatment that is effective, free from systemic adverse effects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable type-2-diabetes-mellitus
Started Oct 2023
Shorter than P25 for not_applicable type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2023
CompletedStudy Start
First participant enrolled
October 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2024
CompletedFirst Posted
Study publicly available on registry
January 23, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2024
CompletedJanuary 23, 2024
January 1, 2024
3 months
October 27, 2023
January 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Role of acetylcholine iontophoresis in improving Nitric oxide level in diabetic peripheral neuropathy patients.
Blood samples were withdrawn from visible peripheral veins by venipuncture then centrifuged and serum was used for nitric oxide level assessment (No micromole/liter) , Nitric oxide measured using commercially available calorimetric assay kits using spectrophotometer (chem7 erba, labomed, Germany). Suspected improvement in nitric oxide level by acetylcholine iontophoresis, patient will receive three sessions iontophoresis weekly for one month and No will be assessed baseline and post assay will be done pre (baseline) and post acetylcholine iontophoresis exposure and aerobic exercise.
one month (baseline assessment and after one month of Ach iontophoresis and exercise)
Electrophysiological assessment of patients with acetylcholine iontophoresis and Ach iontophoresis role in improving diabetic peripheral neuropathy
Nerve conduction velocity of nerves and needle EMG of upper limb and lower limbs will be assessed pre and post exposure, expecting improvement in nerve conduction velocity (expressed latency ms, amplitude mv).
one month (baseline assessment and after one month of Ach iontophoresis and exercise)
Numerical rating pain scale
Patient just say the level of pain feeling, zero means no pain, while 10 means most intense pain possible. Expecting pain improvement after one month of Ach iontophoresis and exercise
One month
Study Arms (2)
Study group (A)
ACTIVE COMPARATOR* 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.
Control group (B)
SHAM COMPARATOR* 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.
Interventions
Acetylcholine Iontophoresis 15 min/ three sessions/ week for two weeks.
Shame Acetylcholine Iontophoresis 15 min/ three sessions/ week for two weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Implanted cardiac pacemakers.
- Patients with known skin allergies.
- Presence of skin inflammations.
- Peripheral vascular disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Physical Therapy, South Valley University
Qina, 83523, Egypt
Related Publications (4)
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.
PMID: 16171612BACKGROUNDAlzahrani 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.
PMID: 20847109BACKGROUNDGoyal 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.
BACKGROUNDBarwick 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.
PMID: 27486520BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator.
Study Record Dates
First Submitted
October 27, 2023
First Posted
January 23, 2024
Study Start
October 28, 2023
Primary Completion
January 20, 2024
Study Completion
January 30, 2024
Last Updated
January 23, 2024
Record last verified: 2024-01