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

S

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

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

Trial contacts and locations

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Central trial contact

Ibrahim Ismail Ibrahim Abu zaid, Dr; Reham Ellisy, Dr

Data sourced from clinicaltrials.gov

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