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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05530486
Other study ID # 5.588.474
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 30, 2023
Est. completion date November 30, 2026

Study information

Verified date March 2024
Source Federal University of Piaui
Contact Vinicius Saura Cardoso
Phone 55 86 99984-2919
Email vscfisio@ufpi.edu.br
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date November 30, 2026
Est. primary completion date May 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
CC
Application of placebo LASER
LG1
Application of LASER GasAs 660nm 4 J/cm².
LG2
Application of LASER GasAs 660nm 8 J/cm².
LG3
Application of LASER GasAs 660nm 12 J/cm².
Procedure:
Dressing
Application of Helianthus annuus oil dressing.

Locations

Country Name City State
Brazil Federal University of Piaui Parnaíba Piauí

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Piaui

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in the ulcer area Measure of ulcer area change. Before intervention starts, 5th and 10th week of intervention.
Primary Change in complete ulcer healing Change in the percentage of complete ulcer healing. Before intervention starts, 5th and 10th week of intervention.
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