Acetylcholine Iontophoresis As A New Challenge With Type 2 Diabetic Peripheral Neuropathy: A Possible New Therapy

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Acetylcholine Iontophoresis As A New Challenge With Type 2 Diabetic Peripheral Neuropathy: A Possible New Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06219590
• Other study ID #: Ach Iontophoresis neuropathy
• Status: Recruiting
• Phase: N/A
• Start date: October 28, 2023
• Est. completion date: January 30, 2024

Study information

• Verified date: January 2024
• Source: South Valley University
• Contact: Reham Ellisy, Dr
• Phone: 01122747361
• Email: rehamabdelrazekr[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The investigators studied endothelial-mediated microvascular blood flow in neuropathic diabetic patients to determine the association between endothelial regulation of the microcirculation and the expression of endothelial constitutive nitric oxide synthetase (NOS). As a result, the nerve fibers can become damaged. Once the nerves have been damaged they cannot repair themselves.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 30, 2024
• Est. primary completion date: January 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Peripheral Nervous System Diseases
• Peripheral Neuropathy
• Type 2 Diabetes Mellitus

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy, South Valley University	Qina

Sponsors (1)

Lead Sponsor	Collaborator
South Valley University

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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