Hyperbaric Oxygen Therapy Versus High Power Laser for Diabetic Neuropathy (HBOT-HPLT-DPN)

September 25, 2026 updated by: Mostafa Mahmoud Mohamed Youssef Khalifa, Cairo University

Hyperbaric Oxygen Therapy Versus High Power Laser Therapy On Sensorimotor Functions In Patients With Diabetic Peripheral Neuropathy

The purpose of this study is to compare the clinical effects of Hyperbaric Oxygen Therapy (HBOT) versus High-Intensity Laser Therapy (HPLT) on sensorimotor functions and nerve conduction in patients suffering from painful diabetic peripheral neuropathy.

Participants are divided into three equal groups. The first group receives a traditional physiotherapy program focused on ankle and foot exercises. The second group receives hyperbaric oxygen therapy sessions in addition to the traditional program. The third group receives high-power MLS laser therapy alongside the traditional program. Investigators look at whether either advanced intervention shows superiority in improving nerve functionality and reducing neuropathic pain.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Diabetic peripheral neuropathy (DPN) is a major microvascular complication of diabetes leading to progressive nerve damage and neuropathic pain. This randomized controlled trial evaluates and compares the efficacy of two non-pharmacological interventions: Hyperbaric Oxygen Therapy (HBOT) and High-Intensity Laser Therapy (HPLT).

A total of 66 medically controlled patients with painful diabetic neuropathy are randomly assigned into three equal parallel groups (22 patients per group):

  • Control Group (A): Receives a traditional physiotherapy program including foot and ankle ROM exercises, strengthening, and functional walking training for 5 sessions per week for 3 weeks.
  • Study Group (B): Receives Hyperbaric Oxygen Therapy (100% oxygen at 2.5 ATA for 60 minutes, totaling 90 minutes per session) for 15 sessions over 3 weeks, combined with the traditional physiotherapy program.
  • Study Group (C): Receives High-Power Laser Therapy using a Multiwave Locked System (MLS) laser device (1500 Hz frequency) applied every other day for 9 sessions over 3 weeks, combined with the traditional physiotherapy program.

Assessments are conducted before and after the 3-week treatment period using objective Nerve Conduction Studies (NCS) for the sural and common peroneal nerves, and subjective screening via the Arabic Michigan Neuropathy Screening Instrument (MNSI) score.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt, 11771
        • Kobri El Koba Military Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients diagnosed with type 2 diabetes mellitus for more than 5 years.
  • Presence of painful diabetic peripheral neuropathy lasting for more than 6 months.
  • Presence of sensory abnormalities, burning pain, and impaired nerve conduction velocity in the lower extremities.
  • Medically controlled glycemic status.
  • Sufficient cognitive abilities with a Mini-Mental State Examination (MMSE) score greater than 24.
  • Fit for hyperbaric pressure therapy with a cardiac ejection fraction (CEF) equal to or greater than 50% and blood pressure equal to or less than 150/90 mmHg.

Exclusion Criteria:

  • Peripheral neuropathy resulting from causes other than diabetes (e.g., vitamin B12 deficiency, alcohol abuse, or trauma).
  • Severe vascular insufficiency in the lower limbs.
  • Uncontrolled medical conditions such as tumors or thyroid dysfunction.
  • Pregnancy.
  • Presence of metallic implantations or cardiac pacemakers.
  • Severe visual, auditory, or cognitive impairment (MMSE score less than 24).
  • Chronic obstructive pulmonary disease (COPD) or other contraindications to hyperbaric oxygen therapy.
  • History of other neurological diseases (e.g., stroke or multiple sclerosis).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Conventional Physiotherapy

Foot and ankle range of motion (ROM) exercises, strengthening exercises, functional exercises, and walking training (5 sessions per week for 3 weeks).
Other: Conventional Physiotherapy Program

Foot and ankle range of motion (ROM) exercises, strengthening exercises, functional exercises, and walking training (5 sessions per week for 3 weeks)
Experimental: Hyperbaric Oxygen Therapy (HBOT)

Conventional physiotherapy program plus HBOT sessions (100% oxygen at 2.5 ATA for 60 minutes, with 15 minutes gradual compression and 15 minutes decompression, totaling 90 minutes per session). 15 sessions over 3 weeks.
Device: Hyperbaric Oxygen Therapy

100% oxygen inhalation at 2.5 ATA pressure for 60 minutes inside a hyperbaric chamber.

Other Names:
  • HPOT
Experimental: High-Power Laser Therapy (HPLT)

Conventional physiotherapy program plus HPLT (MLS laser, M6). Applied every other day for 9 sessions over 3 weeks. Includes a remote foot scan followed by contact application on 7 specific lower extremity areas.
Device: High-Intensity Laser Therapy

MLS laser (M6 device) at 1500 Hz frequency, applied every other day for 9 sessions over 3 weeks. Includes a remote foot scan followed by contact application on 7 specific lower extremity areas.

Other Names:
  • HPLT

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Michigan Neuropathy Screening Instrument (MNSI) score
Time Frame: Baseline and 3 weeks post-treatment

The Michigan Neuropathy Screening Instrument (MNSI) questionnaire was used to assess symptoms of diabetic peripheral neuropathy. Abnormal responses were summed to obtain the total score. The questionnaire score ranges from 0 to 13, with higher scores indicating greater neuropathic symptom burden.
Baseline and 3 weeks post-treatment
Change in right sural nerve distal sensory latency
Time Frame: Baseline and after 3 weeks of treatment

Right sural nerve distal sensory latency was assessed using nerve conduction studies and measured in milliseconds (ms).
Baseline and after 3 weeks of treatment
Change in left sural nerve distal sensory latency
Time Frame: Baseline and after 3 weeks of treatment

Left sural nerve distal sensory latency was assessed using nerve conduction studies and measured in milliseconds (ms).
Baseline and after 3 weeks of treatment
Change in right sural nerve sensory amplitude
Time Frame: Baseline and after 3 weeks of treatment

Right sural nerve sensory amplitude was assessed using nerve conduction studies and measured in microvolts (µV).
Baseline and after 3 weeks of treatment
Change in left sural nerve sensory amplitude
Time Frame: Baseline and after 3 weeks of treatment

Left sural nerve sensory amplitude was assessed using nerve conduction studies and measured in microvolts (µV).
Baseline and after 3 weeks of treatment
Change in right sural nerve conduction velocity
Time Frame: Baseline and after 3 weeks of treatment

Right sural nerve conduction velocity was assessed using nerve conduction studies and measured in meters per second (m/s).
Baseline and after 3 weeks of treatment
Change in left sural nerve conduction velocity
Time Frame: Baseline and after 3 weeks of treatment

Left sural nerve conduction velocity was assessed using nerve conduction studies and measured in meters per second (m/s).
Baseline and after 3 weeks of treatment
Change in right peroneal nerve distal motor latency
Time Frame: Baseline and after 3 weeks of treatment

Right peroneal nerve distal motor latency was assessed using nerve conduction studies and measured in milliseconds (ms).
Baseline and after 3 weeks of treatment
Change in left peroneal nerve distal motor latency
Time Frame: Baseline and after 3 weeks of treatment

Left peroneal nerve distal motor latency was assessed using nerve conduction studies and measured in milliseconds (ms).
Baseline and after 3 weeks of treatment
Change in right peroneal nerve motor amplitude
Time Frame: Baseline and after 3 weeks of treatment

Right peroneal nerve motor amplitude was assessed using nerve conduction studies and measured in millivolts (mV).
Baseline and after 3 weeks of treatment
Change in left peroneal nerve motor amplitude
Time Frame: Baseline and after 3 weeks of treatment

Left peroneal nerve motor amplitude was assessed using nerve conduction studies and measured in millivolts (mV).
Baseline and after 3 weeks of treatment
Change in right peroneal nerve motor conduction velocity
Time Frame: Baseline and after 3 weeks of treatment

Right peroneal nerve motor conduction velocity was assessed using nerve conduction studies and measured in meters per second (m/s).
Baseline and after 3 weeks of treatment
Change in left peroneal nerve motor conduction velocit
Time Frame: Baseline and after 3 weeks of treatment

Left peroneal nerve motor conduction velocity was assessed using nerve conduction studies and measured in meters per second (m/s).
Baseline and after 3 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 6, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 6, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 31, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 30, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P.T.REC/012/005181

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared outside the research team to maintain patient privacy and data confidentiality in accordance with institutional guidelines.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings