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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-28

Study Completion Date

2024-01-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Type 2 Diabetes Mellitus Peripheral Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

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.

Group Type ACTIVE_COMPARATOR

Acetylcholine Iontophoresis

Intervention Type PROCEDURE

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.

Group Type SHAM_COMPARATOR

Shame Acetylcholine Iontophoresis

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Shame Acetylcholine Iontophoresis

Shame Acetylcholine Iontophoresis 15 min/ three sessions/ week for two weeks.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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South Valley University

OTHER

Sponsor Role lead

Responsible Party

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Reham Abdelrazek Mohamed Ellisy

Principal investigator.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Physical Therapy, South Valley University

Qina, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Reham Ellisy, Dr

Role: CONTACT

01122747361

Ibrahim Ismail Ibrahim Abu zaid, Dr

Role: CONTACT

01006512150

Facility Contacts

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Reham A Ellisy, MD

Role: primary

+201020081816

Ibrahim I Abuzaid, MD

Role: backup

01006512150

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.

Reference Type BACKGROUND
PMID: 16171612 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20847109 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 27486520 (View on PubMed)

Other Identifiers

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Ach Iontophoresis neuropathy

Identifier Type: -

Identifier Source: org_study_id

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