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

South Valley University

Status: Enrolling

Conditions: Peripheral Neuropathy; Type 2 Diabetes Mellitus

Treatments: Procedure: Shame Acetylcholine Iontophoresis; Procedure: Acetylcholine Iontophoresis

Study type: Interventional

Funder types: Other

Identifiers

NCT06219590

Ach Iontophoresis neuropathy

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

Study group (A)

Active Comparator group

Description:

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.

Treatment:

Procedure: Acetylcholine Iontophoresis

Control group (B)

Sham Comparator group

Description:

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.

Treatment:

Procedure: Shame Acetylcholine Iontophoresis