NCT05404191

Brief Summary

The purpose of this study is to investigate whether patients' age, total burned surface area, wound stage and wound depth determine wound healing response to low level laser therapy in burn patients

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 3, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2023

Completed
Last Updated

January 10, 2023

Status Verified

January 1, 2023

Enrollment Period

2 months

First QC Date

May 3, 2022

Last Update Submit

January 9, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • reduced wound surface area

    measure of wound surface area using manual tracing method before and after application of treatment

    maximum of 6 weeks

Study Arms (1)

burn wound receiving low level laser therapy

EXPERIMENTAL
Device: low level laser therapy

Interventions

Low level laser therapy will be performed for 30 min 3 times per week for 8 weeks on the wound area. Wound area was irradiated by a red 655 nm light, 150 mW, 2 J/cm2 at the bed of the wound.

burn wound receiving low level laser therapy

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Partial thickness Burn wound depth.
  • Age ranges from 20-50 years.
  • TBSA more than 15%
  • Sufficient understanding to perform the test

You may not qualify if:

  • Diabetic patients.
  • Burn wound with skin graft
  • Infected wounds
  • Patients receiving immunosuppressive drugs.
  • Patients receiving irradiation or chemotherapy.
  • Chronic circulatory diseases
  • Severe associated injury with burn.
  • Associated co-morbidities, such as neurological diseases, malnutrition, and other inflammatory and/or infectious diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Burns

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Central Study Contacts

Ahmed M. nagy

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 60 adult of both sexes will participate in this study selected from burn unit of AHMED ORABI hospital, Their ages range from 10 to 50 years, TBSA more than 15%, partial thickness burn depth.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of physical therapy for surgery- Cairo university

Study Record Dates

First Submitted

May 3, 2022

First Posted

June 3, 2022

Study Start

December 1, 2022

Primary Completion

January 15, 2023

Study Completion

January 15, 2023

Last Updated

January 10, 2023

Record last verified: 2023-01

Locations