NCT05530486

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 7, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

June 30, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
Last Updated

June 12, 2025

Status Verified

March 1, 2024

Enrollment Period

1.9 years

First QC Date

September 1, 2022

Last Update Submit

June 10, 2025

Conditions

WoundDiabetic FootLTBI

Keywords

Diabetes MellitusLow-Level Light TherapyDiabetic Foot

Outcome Measures

Primary Outcomes (2)

  • Change in the ulcer area

    Measure of ulcer area change.

    Before intervention starts, 5th and 10th week of intervention.

  • Change in complete ulcer healing

    Change in the percentage of complete ulcer healing.

    Before intervention starts, 5th and 10th week of intervention.

Study Arms (4)

Comparador de placebo: CC + curativo

PLACEBO COMPARATOR

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

Device: CCProcedure: Dressing

Comparador ativo: LG1 + curativo

ACTIVE COMPARATOR

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

Device: LG1Procedure: Dressing

Comparador ativo: LG2 + curativo

ACTIVE COMPARATOR

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

Device: LG2Procedure: Dressing

Comparador ativo: LG3 + curativo

ACTIVE COMPARATOR

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

Device: LG3Procedure: Dressing

Interventions

CCDEVICE

Application of placebo LASER

Comparador de placebo: CC + curativo
LG1DEVICE

Application of LASER GasAs 660nm 4 J/cm².

Comparador ativo: LG1 + curativo
LG2DEVICE

Application of LASER GasAs 660nm 8 J/cm².

Comparador ativo: LG2 + curativo
LG3DEVICE

Application of LASER GasAs 660nm 12 J/cm².

Comparador ativo: LG3 + curativo
DressingPROCEDURE

Application of Helianthus annuus oil dressing.

Comparador ativo: LG1 + curativoComparador ativo: LG2 + curativoComparador ativo: LG3 + curativoComparador de placebo: CC + curativo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Piaui

Parnaíba, Piauí, 64202-020, Brazil

Location

Related Publications (1)

  • Bezerra Miranda M, Silva Barros AC, Veloso Coelho L, Barbosa da Rocha R, Antonio Kato da Silva B, Ahmad Hazime F, Tanuri Magalhaes A, Saura Cardoso V. Dose-response and efficacy of 660-nanometer low-level laser therapy in healing diabetic foot ulcers: a randomized, double-blind, clinical trial. Lasers Med Sci. 2025 Oct 1;40(1):399. doi: 10.1007/s10103-025-04641-2.

    PMID: 41028567DERIVED

MeSH Terms

Conditions

Wounds and InjuriesDiabetic FootDiabetes Mellitus

Interventions

Bandages

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsEndocrine System DiseasesDiabetic NeuropathiesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Vinicius Saura Cardoso

    Federal University of Piaui

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 1, 2022

First Posted

September 7, 2022

Study Start

June 30, 2023

Primary Completion

May 30, 2025

Study Completion

May 30, 2025

Last Updated

June 12, 2025

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)