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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Comparador de placebo: CC + curativo | Placebo Comparator | The group will receive placebo LASER application associated with Helianthus annuus oil 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CC | Device | Application of placebo LASER |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vinicius Saura Cardoso | Federal University of Piaui | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of Piaui | Parnaíba | Piauí | 64202-020 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41028567 | Derived | 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. |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D017719 | Diabetic Foot |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| ID | Term |
|---|---|
| D001458 | Bandages |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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| LG1 |
| Device |
Application of LASER GasAs 660nm 4 J/cm². |
|
| LG2 | Device | Application of LASER GasAs 660nm 8 J/cm². |
|
| LG3 | Device | Application of LASER GasAs 660nm 12 J/cm². |
|
| Dressing | Procedure | Application of Helianthus annuus oil dressing. |
|
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |