Diabetic NephropathiesNCT06884462
Effect of High-intensity Laser Exercise Versus Moderate-intensity Aerobic Exercise on Diabetic Polyneuropathy Patients
A study testing High-intensity laser (HIL) and moderate-intensity aerobic exercise in people with Diabetic Nephropathies, run by Deraya University at 1 site in Egypt.
Trial summary
Diabetic poly neuropathy (DPN) is a length-dependent, symmetrical sensorimotor poly neuropathy and is among the most prevalent and challenging consequences of diabetes4. The documented prevalence of DPN varies between 13% and 55%, with 25% to 50% of these individuals experiencing neuropathic pain5. Read more about this study
- Who is it for?
- Ages 30 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetic Nephropathies
- What is being tested?
- High-intensity laser (HIL) and moderate-intensity aerobic exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Neuropathic symptoms in the lower limbs, including numbness, tingling, pain, burning, electric shock, and stabbing
Who cannot join
- sensory polyneuropathy unrelated to diabetes as
- systemic diseases,
- infections,
- inflammatory conditions,
- drug effects,
- metal exposure,
- hereditary factors
Trial locations and contacts
1 site in 1 country.
About this study
Diabetic poly neuropathy (DPN) is a length-dependent, symmetrical sensorimotor poly neuropathy and is among the most prevalent and challenging consequences of diabetes4.
The documented prevalence of DPN varies between 13% and 55%, with 25% to 50% of these individuals experiencing neuropathic pain5. This study was conducted to find out the impact of high-intensity laser versus moderate-intensity aerobic exercises on diabetic poly neuropathy patients.
- Conditions
- Diabetic Nephropathies
- Being tested
- High-intensity laser (HIL), moderate-intensity aerobic exercise
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity laser (HIL)Radiation
The wavelength measured 1064 nm, accompanied by a power output of 5.00 W. The frequency employed was 25 Hz
moderate-intensity aerobic exerciseProcedure or surgery
walking on a treadmill at a speed of 3-4 miles per hour on a flat surface (0% incline) for 40 minutes, 3 times weekly over eight weeks
| Study group | Role | What they receive |
|---|---|---|
| HIL treatment group | Experimental | 30 patients with DPN who were advised to undergo HIL treatment for eight weeks Receives: Radiation: High-intensity laser (HIL) |
| Moderate-intensity aerobic exercise group | Experimental | 30 patients receive moderate-intensity aerobic exercise Receives: Procedure: moderate-intensity aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower extremity functional performance
scale for both groups from 0 (minimum) to 80 (maximum)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start1 Nov 2024
- Primary completion1 Jan 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deraya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06884462
- Sponsor's protocol ID
- physio 1 2025
- Status last verified
- Sep 2025
- First submitted
- 13 Mar 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High-intensity Laser Exercise Versus Moderate-intensity Aerobic Exercise on Diabetic Polyneuropathy Patients
- ClinicalTrials.gov ID
- NCT06884462
- Acronym / sponsor ID
- physio 1 2025
- Conditions
- Diabetic Nephropathies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Deraya UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 19 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diabetic poly neuropathy (DPN) is a length-dependent, symmetrical sensorimotor poly neuropathy and is among the most prevalent and challenging consequences of diabetes4.
The documented prevalence of DPN varies between 13% and 55%, with 25% to 50% of these individuals experiencing neuropathic pain5. This study was conducted to find out the impact of high-intensity laser versus moderate-intensity aerobic exercises on diabetic poly neuropathy patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIL treatment group | Experimental | Radiation: High-intensity laser (HIL)30 patients with DPN who were advised to undergo HIL treatment for eight weeks |
| Moderate-intensity aerobic exercise group | Experimental | Procedure: moderate-intensity aerobic exercise30 patients receive moderate-intensity aerobic exercise |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Neuropathic symptoms in the lower limbs, including numbness, tingling, pain, burning, electric shock, and stabbing
Key exclusion criteria (7 listed)
- sensory polyneuropathy unrelated to diabetes as
- systemic diseases,
- infections,
- inflammatory conditions,
- drug effects,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-intensity laser (HIL)The wavelength measured 1064 nm, accompanied by a power output of 5.00 W. The frequency employed was 25 Hz | Radiation | HIL treatment group |
| moderate-intensity aerobic exercisewalking on a treadmill at a speed of 3-4 miles per hour on a flat surface (0% incline) for 40 minutes, 3 times weekly over eight weeks | Procedure or surgery | Moderate-intensity aerobic exercise group |
Primary outcome
Lower extremity functional performance
Time frame: 3 months
scale for both groups from 0 (minimum) to 80 (maximum)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity laser (HIL) and moderate-intensity aerobic exercise in people with Diabetic Nephropathies, run by Deraya University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower extremity functional performance (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.