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Quality of Life and Self-care in Patients With Diabetic Foot Ulcers Treated With Low-level Laser Therapy

Primary Purpose

Diabetic Foot Ulcer, Diabetic Foot

Status
Recruiting
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
LG1 (LLLT group 1)
LG2 (LLLT group 2)
LG3 (LLLT group 3)
CG (control group)
Dressing
Sponsored by
Federal University of Piaui
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Type 2 diabetes mellitus patients with diabetic foot ulcers;
  • Patients aged 18 to 79 years.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Federal University of PiauiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

CG (control group) + dressing

LG1 (LLLT group 1) + dressing

LG2 (LLLT group 2) + dressing

LG3 (LLLT group 3) + dressing

Arm Description

The group will receive placebo LLLT (low-level laser therapy) application associated with Helianthus annuus oil dressing.

The group will receive application of LLLT (low-level laser therapy) Gallium Arsenide (GaAs) 904 nm 10 J/cm² associated with Helianthus annuus oil dressing.

The group will receive application of LLLT (low-level laser therapy) Gallium Arsenide (GaAs) 904 nm 8 J/cm² associated with Helianthus annuus oil dressing.

The group will receive application of LLLT (low-level laser therapy) Gallium Arsenide (GaAs) 904 nm 4 J/cm² associated with Helianthus annuus oil dressing.

Outcomes

Primary Outcome Measures

Initial quality of life (QoL)
Quality of life assessed by the SF-36 questionnaire.
Final quality of life (QoL)
Quality of life assessed by the SF-36 questionnaire.
Quality of life (QoL) follow up
Quality of life assessed by the SF-36 questionnaire.

Secondary Outcome Measures

Healing time
Total applications performed until healing.
Percentage of complete healing in 5th week
Percentage of patients achieving healing in each group.
Percentage of complete healing in 10th week
Percentage of patients achieving healing in each group.
Percentage of complete healing follow up
Percentage of patients achieving healing in each group.
Self-care
Adherence to self-care assessed by the Summary of Diabetes Self-Care Activities (SDSCA) questionnaire.
Change in self-care
Adherence to self-care assessed by the Summary of Diabetes Self-Care Activities (SDSCA) questionnaire.
Visual analogue scale (VAS)
Levels of pain in the feet assessed using the visual analogue scale (VAS). With scores ranging from 0 to 100, 0 being no pain and 100 being the worst pain that the patient imagines.
Change in visual analogue scale (VAS)
Levels of pain in the feet assessed using the visual analogue scale (VAS). With scores ranging from 0 to 100, 0 being no pain and 100 being the worst pain that the patient imagines.

Full Information

First Posted
September 13, 2021
Last Updated
July 25, 2022
Sponsor
Federal University of Piaui
Collaborators
Foundation for research support of the state of Piaui
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1. Study Identification

Unique Protocol Identification Number
NCT05071235
Brief Title
Quality of Life and Self-care in Patients With Diabetic Foot Ulcers Treated With Low-level Laser Therapy
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 27, 2019 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
November 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Piaui
Collaborators
Foundation for research support of the state 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
No

5. Study Description

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).
Detailed Description
Eighty volunteers will be recruited through the Integrated Center of Medical Specialties (ICMS) and the Center of Health Specialties (CHS) in Parnaíba-PI, Brazil, after thorough examination of the feet and evaluation by a medical professional specializing in vascular surgery. Volunteers with type 2 diabetes mellitus (T2DM) who have DFU without an infectious process (Wagner's grade I and II) will be admitted, of both sexes aged 18 years and over. Inclusion in the study will take place after signing the Informed Consent Form (ICF). The randomization will be of the simple type, a computer generated randomization list through the website https://www.randomizer.org will be used to prepare sealed, opaque and sequentially numbered envelopes. A collaborator, who will not participate in the study, will carry out the randomization process, subsequently inserting the allocation data in the envelope. After inclusion, volunteers will be evaluated individually in a reserved room, by a previously trained evaluator and blinded to the allocation of volunteers in the groups. Volunteers will provide their personal data, medical history and duration of T2DM. Subsequently, the physical evaluation and application of the questionnaires will be carried out: (1) application of the SF-36 (Short Form-36 Health Survey) and Summary of Diabetes Self-Care Activities (SDSCA) questionnaires in the form of an interview; (2) vascular evaluation; (3) neurological evaluation; (4) determination of the level of pain and (5) capillary blood glucose. The DFU will be located, recording the affected foot region, the duration in months and the Wagner's classification. The healing process of DFU will be monitored. The total number of LLLT applications performed until complete healing will be identified and the percentage of patients who achieved healing in relation to the cutoff points of the fifth and tenth weeks of intervention. The volunteers in the treatment groups will receive dosage as pre-established (10, 8 or 4 J/cm²) and those in the control group (CG) will receive a placebo application, that is, with the device turned off. For the treatment, the laser tip will be positioned perpendicular to the DFU, the ulcer floor will be irradiated with a sweeping application technique (1 cm away from the ulcer) and the edges with a punctual technique with contact at equidistant points. The total duration of each application will be calculated by the machine based on the selected energy density. Both the therapist and the participant will use the goggles provided before the application. The four groups will receive conventional treatment, cleansing the ulcers with saline solution and dressing with Helianthus Annuus oil. It is expected that the participants in the treatment groups will show significant improvement in QoL and pain after the intervention, less time and a higher percentage of healing compared to the CG. Differences in the improvement of QoL and pain and in the time and percentage of healing between the LLLT dosages used are also expected. It is also assumed that adherence to self-care is capable of predicting the time and percentage of healing and QoL, in the perception that the improvement of the patient with LLLT is also influenced by his attitudes and that self-care also has effects on QoL.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer, Diabetic Foot

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CG (control group) + dressing
Arm Type
Placebo Comparator
Arm Description
The group will receive placebo LLLT (low-level laser therapy) application associated with Helianthus annuus oil dressing.
Arm Title
LG1 (LLLT group 1) + dressing
Arm Type
Active Comparator
Arm Description
The group will receive application of LLLT (low-level laser therapy) Gallium Arsenide (GaAs) 904 nm 10 J/cm² associated with Helianthus annuus oil dressing.
Arm Title
LG2 (LLLT group 2) + dressing
Arm Type
Active Comparator
Arm Description
The group will receive application of LLLT (low-level laser therapy) Gallium Arsenide (GaAs) 904 nm 8 J/cm² associated with Helianthus annuus oil dressing.
Arm Title
LG3 (LLLT group 3) + dressing
Arm Type
Active Comparator
Arm Description
The group will receive application of LLLT (low-level laser therapy) Gallium Arsenide (GaAs) 904 nm 4 J/cm² associated with Helianthus annuus oil dressing.
Intervention Type
Device
Intervention Name(s)
LG1 (LLLT group 1)
Intervention Description
Application of LLLT (low-level laser therapy) AsGa 904 nm 10 J/cm².
Intervention Type
Device
Intervention Name(s)
LG2 (LLLT group 2)
Intervention Description
Application of LLLT (low-level laser therapy) AsGa 904 nm 8 J/cm².
Intervention Type
Device
Intervention Name(s)
LG3 (LLLT group 3)
Intervention Description
Application of LLLT (low-level laser therapy) AsGa 904 nm 4 J/cm².
Intervention Type
Device
Intervention Name(s)
CG (control group)
Intervention Description
Application of placebo LLLT (low-level laser therapy), that is, with the device turned off.
Intervention Type
Procedure
Intervention Name(s)
Dressing
Intervention Description
Application of Helianthus annuus oil dressing.
Primary Outcome Measure Information:
Title
Initial quality of life (QoL)
Description
Quality of life assessed by the SF-36 questionnaire.
Time Frame
Before intervention starts.
Title
Final quality of life (QoL)
Description
Quality of life assessed by the SF-36 questionnaire.
Time Frame
In 10th week of intervention or after DFU healing (in ulcers that healed before 10 weeks).
Title
Quality of life (QoL) follow up
Description
Quality of life assessed by the SF-36 questionnaire.
Time Frame
1 month after the end of the intervention.
Secondary Outcome Measure Information:
Title
Healing time
Description
Total applications performed until healing.
Time Frame
In 10th week of intervention or after DFU healing (in ulcers that healed before 10 weeks).
Title
Percentage of complete healing in 5th week
Description
Percentage of patients achieving healing in each group.
Time Frame
In 5th week of intervention.
Title
Percentage of complete healing in 10th week
Description
Percentage of patients achieving healing in each group.
Time Frame
In 10th week of intervention.
Title
Percentage of complete healing follow up
Description
Percentage of patients achieving healing in each group.
Time Frame
1 month after the end of the final intervention.
Title
Self-care
Description
Adherence to self-care assessed by the Summary of Diabetes Self-Care Activities (SDSCA) questionnaire.
Time Frame
Before intervention starts.
Title
Change in self-care
Description
Adherence to self-care assessed by the Summary of Diabetes Self-Care Activities (SDSCA) questionnaire.
Time Frame
In 10th week of intervention or after DFU healing (in ulcers that healed before 10 weeks).
Title
Visual analogue scale (VAS)
Description
Levels of pain in the feet assessed using the visual analogue scale (VAS). With scores ranging from 0 to 100, 0 being no pain and 100 being the worst pain that the patient imagines.
Time Frame
Before intervention starts.
Title
Change in visual analogue scale (VAS)
Description
Levels of pain in the feet assessed using the visual analogue scale (VAS). With scores ranging from 0 to 100, 0 being no pain and 100 being the worst pain that the patient imagines.
Time Frame
In 10th week of intervention or after DFU healing (in ulcers that healed before 10 weeks).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 2 diabetes mellitus patients with diabetic foot ulcers; Patients aged 18 to 79 years. Exclusion Criteria: 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.
Facility Information:
Facility Name
Federal University of Piaui
City
Parnaíba
State/Province
Piaui
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandro M Oliveira, Dr
Phone
+55(86)3323-5125
Email
reitoriaufdpar@ufpi.edu.br

12. IPD Sharing Statement

Learn more about this trial

Quality of Life and Self-care in Patients With Diabetic Foot Ulcers Treated With Low-level Laser Therapy

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