NCT06884462

Brief 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. This study was conducted to find out the impact of high-intensity laser versus moderate-intensity aerobic exercises on diabetic poly neuropathy patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 19, 2025

Completed
Last Updated

September 25, 2025

Status Verified

September 1, 2025

Enrollment Period

2 months

First QC Date

March 13, 2025

Last Update Submit

September 20, 2025

Conditions

Diabetic Nephropathies

Outcome Measures

Primary Outcomes (1)

  • Lower extremity functional performance

    scale for both groups from 0 (minimum) to 80 (maximum)

    3 months

Study Arms (2)

HIL treatment group

EXPERIMENTAL

30 patients with DPN who were advised to undergo HIL treatment for eight weeks

Radiation: High-intensity laser (HIL)

Moderate-intensity aerobic exercise group

EXPERIMENTAL

30 patients receive moderate-intensity aerobic exercise

Procedure: moderate-intensity aerobic exercise

Interventions

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

HIL treatment group
moderate-intensity aerobic exercisePROCEDURE

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

Moderate-intensity aerobic exercise group

Eligibility Criteria

Age30 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Neuropathic symptoms in the lower limbs, including numbness, tingling, pain, burning, electric shock, and stabbing

You may not qualify if:

  • sensory polyneuropathy unrelated to diabetes as
  • systemic diseases,
  • infections,
  • inflammatory conditions,
  • drug effects,
  • metal exposure,
  • hereditary factors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soad

Minya, 05637, Egypt

Location

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2025

First Posted

March 19, 2025

Study Start

November 1, 2024

Primary Completion

January 1, 2025

Study Completion

March 1, 2025

Last Updated

September 25, 2025

Record last verified: 2025-09

Locations

EG(1)