Quality of Life and Self-care in Patients With Diabetic Foot Ulcers Treated With Low-level Laser Therapy
Quality of Life of Patients With Diabetic Foot Ulcers Treated With LLLT 904 nm and Aspects Associated With Self-care Adherence: a Randomized Clinical Trial
1 other identifier
interventional
80
1 country
1
Brief Summary
Diabetic foot ulcers (DFU) are aggressive complications of diabetes mellitus (DM) and affect 25% of these patients. DFU are associated with a high risk of amputations and early mortality and significantly impact quality of life (QoL). The low-level laser therapy (LLLT) is an important approach for the treatment of DFU, however there is a lack of data on its influence on the QoL of patients with DFU. On the other hand, adherence to self-care is a factor closely related to QoL. Therefore, this study is justified by the need to understand the impact of LLLT on QoL and its relationship with self-care. Aim: To evaluate the quality of life of patients with diabetic foot ulcers treated with different doses of LLLT (GaAs) 904 nm and its association with aspects of adherence to self-care. Methods: This is a randomized, double-blind, placebo-controlled clinical trial. Participants will be randomly assigned to the groups: control LLLT placebo (CG), LLLT 904 nm 10 J/cm² (LG1), LLLT 904 nm 8 J/cm² (LG2) and LLLT 904 nm 4 J/cm² (LG3). QoL data, percentage of healing and pain will be assessed before the start of the intervention, in 10th week and after one month to the end of intervention, self-care will be assessed before the start of the intervention and at the end of intervention. Eighty participants with DFU will be recruited who will receive intervention twice a week for up to 20 visits (10 weeks).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 27, 2019
CompletedFirst Submitted
Initial submission to the registry
September 13, 2021
CompletedFirst Posted
Study publicly available on registry
October 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2022
CompletedFebruary 22, 2024
February 1, 2024
2.3 years
September 13, 2021
February 21, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
Initial quality of life (QoL)
Quality of life assessed by the SF-36 questionnaire.
Before intervention starts.
Final quality of life (QoL)
Quality of life assessed by the SF-36 questionnaire.
In 10th week of intervention or after DFU healing (in ulcers that healed before 10 weeks).
Quality of life (QoL) follow up
Quality of life assessed by the SF-36 questionnaire.
1 month after the end of the intervention.
Secondary Outcomes (8)
Healing time
In 10th week of intervention or after DFU healing (in ulcers that healed before 10 weeks).
Percentage of complete healing in 5th week
In 5th week of intervention.
Percentage of complete healing in 10th week
In 10th week of intervention.
Percentage of complete healing follow up
1 month after the end of the final intervention.
Self-care
Before intervention starts.
- +3 more secondary outcomes
Study Arms (4)
CG (control group) + dressing
PLACEBO COMPARATORThe group will receive placebo LLLT (low-level laser therapy) application associated with Helianthus annuus oil dressing.
LG1 (LLLT group 1) + dressing
ACTIVE COMPARATORThe group will receive application of LLLT (low-level laser therapy) Gallium Arsenide (GaAs) 904 nm 10 J/cm² associated with Helianthus annuus oil dressing.
LG2 (LLLT group 2) + dressing
ACTIVE COMPARATORThe group will receive application of LLLT (low-level laser therapy) Gallium Arsenide (GaAs) 904 nm 8 J/cm² associated with Helianthus annuus oil dressing.
LG3 (LLLT group 3) + dressing
ACTIVE COMPARATORThe group will receive application of LLLT (low-level laser therapy) Gallium Arsenide (GaAs) 904 nm 4 J/cm² associated with Helianthus annuus oil dressing.
Interventions
Application of LLLT (low-level laser therapy) AsGa 904 nm 10 J/cm².
Application of LLLT (low-level laser therapy) AsGa 904 nm 8 J/cm².
Application of LLLT (low-level laser therapy) AsGa 904 nm 4 J/cm².
Application of placebo LLLT (low-level laser therapy), that is, with the device turned off.
Application of Helianthus annuus oil dressing.
Eligibility Criteria
You may qualify if:
- Type 2 diabetes mellitus patients with diabetic foot ulcers;
- Patients aged 18 to 79 years.
You may not qualify if:
- Presence of autoimmune disease;
- Presence of psychiatric or cognitive disorders that impede the application of questionnaires;
- Pressure ulcers
- Venous ulcers;
- Contraindications to the treatment methods adopted in the research;
- Ulcers in other parts of the body than the feet;
- Diabetic foot ulcers infected.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Federal University of Piaui
Parnaíba, Piauí, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD Professor of the Graduate Program in Biomedical Sciences
Study Record Dates
First Submitted
September 13, 2021
First Posted
October 8, 2021
Study Start
August 27, 2019
Primary Completion
November 30, 2021
Study Completion
November 30, 2022
Last Updated
February 22, 2024
Record last verified: 2024-02