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Effect of the Use of Low Intensity Therapeutic LASER

Primary Purpose

Wound, Diabetic Foot, LTBI

Status
Not yet recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
CC
LG1
LG2
LG3
Dressing
Sponsored by
Federal University of Piaui
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Wound focused on measuring Diabetes Mellitus, Low-Level Light Therapy, Diabetic Foot

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Type 2 diabetes mellitus patients with diabetic foot ulcers;
  • Patients aged 18 and over.

Exclusion Criteria:

  • Patients with autoimmune diseases
  • Patients with concomitant psychiatric disorders
  • Patients with contraindications to treatment methods
  • Patients with infected diabetic foot ulcers.

Sites / Locations

  • Federal University of Piaui

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Comparador de placebo: CC + curativo

Comparador ativo: LG1 + curativo

Comparador ativo: LG2 + curativo

Comparador ativo: LG3 + curativo

Arm Description

The group will receive placebo LASER application associated with Helianthus annuus oil dressing.

The group will receive application of LASER Gallium Arsenide (GasAs) 660 nm 4 J/cm² associated with Helianthus annuus oil dressing.

The group will receive application of LASER Gallium Arsenide (GaAs) 660 nm 8 J/cm² associated with Helianthus annuus oil dressing.

The group will receive application of LASER Gallium Arsenide (GaAs) 660 nm 12 J/cm² associated with Helianthus annuus oil dressing.

Outcomes

Primary Outcome Measures

Change in the ulcer area
Measure of ulcer area change.
Change in complete ulcer healing
Change in the percentage of complete ulcer healing.

Secondary Outcome Measures

Full Information

First Posted
September 1, 2022
Last Updated
September 2, 2022
Sponsor
Federal University of Piaui
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1. Study Identification

Unique Protocol Identification Number
NCT05530486
Brief Title
Effect of the Use of Low Intensity Therapeutic LASER
Official Title
Effect of the Use of Therapeutic Low-intensity 660 nm LASER in the Treatment of Diabetic Ulcers: a Double-blind Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 31, 2023 (Anticipated)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
March 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Piaui

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Diabetes mellitus consists of a heterogeneous group of metabolic disorders that have hyperglycemia in common, resulting from defects in insulin action, insulin secretion, or both. Diabetes mellitus has gained increasing importance and is considered one of the main themes of global health problems due to the damage caused to quality of life, public health and the epidemiological picture presented. Among the complications are diabetic foot ulcers, with higher prevalence in the lower limbs, they are classified as loss of skin continuity, which can reach from the epidermis to deep structures such as muscles, bones and tendons.
Detailed Description
100 volunteers will be recruited and the research will be carried out through the Integrated Center of Medical Specialties (CIEM) - Polyclinic, through referral from the specialist in vascular surgery after a thorough examination of the feet. Volunteers of both sexes, aged over 18 years, DM and diabetic ulcers will be admitted. Volunteers who present any autoimmune disease, concomitant psychiatric disorders or contraindications to the treatment methods adopted by the research will be excluded. Inclusion in the study will take place after signing the informed consent forms, after approval by the Ethics Committee.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound, Diabetic Foot, LTBI
Keywords
Diabetes Mellitus, Low-Level Light Therapy, Diabetic Foot

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Comparador de placebo: CC + curativo
Arm Type
Placebo Comparator
Arm Description
The group will receive placebo LASER application associated with Helianthus annuus oil dressing.
Arm Title
Comparador ativo: LG1 + curativo
Arm Type
Active Comparator
Arm Description
The group will receive application of LASER Gallium Arsenide (GasAs) 660 nm 4 J/cm² associated with Helianthus annuus oil dressing.
Arm Title
Comparador ativo: LG2 + curativo
Arm Type
Active Comparator
Arm Description
The group will receive application of LASER Gallium Arsenide (GaAs) 660 nm 8 J/cm² associated with Helianthus annuus oil dressing.
Arm Title
Comparador ativo: LG3 + curativo
Arm Type
Active Comparator
Arm Description
The group will receive application of LASER Gallium Arsenide (GaAs) 660 nm 12 J/cm² associated with Helianthus annuus oil dressing.
Intervention Type
Device
Intervention Name(s)
CC
Intervention Description
Application of placebo LASER
Intervention Type
Device
Intervention Name(s)
LG1
Intervention Description
Application of LASER GasAs 660nm 4 J/cm².
Intervention Type
Device
Intervention Name(s)
LG2
Intervention Description
Application of LASER GasAs 660nm 8 J/cm².
Intervention Type
Device
Intervention Name(s)
LG3
Intervention Description
Application of LASER GasAs 660nm 12 J/cm².
Intervention Type
Procedure
Intervention Name(s)
Dressing
Intervention Description
Application of Helianthus annuus oil dressing.
Primary Outcome Measure Information:
Title
Change in the ulcer area
Description
Measure of ulcer area change.
Time Frame
Before intervention starts, 5th and 10th week of intervention.
Title
Change in complete ulcer healing
Description
Change in the percentage of complete ulcer healing.
Time Frame
Before intervention starts, 5th and 10th week of intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 2 diabetes mellitus patients with diabetic foot ulcers; Patients aged 18 and over. Exclusion Criteria: Patients with autoimmune diseases Patients with concomitant psychiatric disorders Patients with contraindications to treatment methods Patients with infected diabetic foot ulcers.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vinicius Saura Cardoso
Phone
55 86 99984-2919
Email
vscfisio@ufpi.edu.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vinicius Saura Cardoso
Organizational Affiliation
Federal University of Piaui
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Piaui
City
Parnaíba
State/Province
Piauí
ZIP/Postal Code
64202-020
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of the Use of Low Intensity Therapeutic LASER

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