Diabetic Foot UlcerNCT05071235
Quality of Life and Self-care in Patients With Diabetic Foot Ulcers Treated With Low-level Laser Therapy
A study testing LG1 (LLLT group 1), LG2 (LLLT group 2) and LG3 (LLLT group 3) in people with Diabetic Foot Ulcer and Diabetic Foot, run by Federal University of Piaui at 1 site in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Diabetic Foot Ulcer, Diabetic Foot
- What is being tested?
- LG1 (LLLT group 1), LG2 (LLLT group 2) and LG3 (LLLT group 3)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 27 Aug 2019to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus patients with diabetic foot ulcers;
- Patients aged 18 to 79 years.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- Conditions
- Diabetic Foot Ulcer, Diabetic Foot
- Being tested
- LG1 (LLLT group 1), LG2 (LLLT group 2), LG3 (LLLT group 3), CG (control group), Dressing
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LG1 (LLLT group 1)Device
Application of LLLT (low-level laser therapy) AsGa 904 nm 10 J/cm².
LG2 (LLLT group 2)Device
Application of LLLT (low-level laser therapy) AsGa 904 nm 8 J/cm².
LG3 (LLLT group 3)Device
Application of LLLT (low-level laser therapy) AsGa 904 nm 4 J/cm².
CG (control group)Device
Application of placebo LLLT (low-level laser therapy), that is, with the device turned off.
DressingProcedure or surgery
Application of Helianthus annuus oil dressing.
| Study group | Role | What they receive |
|---|---|---|
| CG (control group) + dressing | Placebo comparator | The group will receive placebo LLLT (low-level laser therapy) application associated with Helianthus annuus oil dressing. Receives: Device: CG (control group); Procedure: Dressing |
| LG1 (LLLT group 1) + dressing | Active comparator | 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. Receives: Device: LG1 (LLLT group 1); Procedure: Dressing |
| LG2 (LLLT group 2) + dressing | Active comparator | 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. Receives: Device: LG2 (LLLT group 2); Procedure: Dressing |
| LG3 (LLLT group 3) + dressing | Active comparator | 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. Receives: Device: LG3 (LLLT group 3); Procedure: Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initial quality of life (QoL)
Quality of life assessed by the SF-36 questionnaire.
Measured: Before intervention starts.
Final quality of life (QoL)
Quality of life assessed by the SF-36 questionnaire.
Measured: 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.
Measured: 1 month after the end of the intervention.
Secondary outcomes (8)
Healing time
Total applications performed until healing.
Measured: In 10th week of intervention or after DFU healing (in ulcers that healed before 10 weeks).
Percentage of complete healing in 5th week
Percentage of patients achieving healing in each group.
Measured: In 5th week of intervention.
Percentage of complete healing in 10th week
Percentage of patients achieving healing in each group.
Measured: In 10th week of intervention.
Percentage of complete healing follow up
Percentage of patients achieving healing in each group.
Measured: 1 month after the end of the final intervention.
Self-care
Adherence to self-care assessed by the Summary of Diabetes Self-Care Activities (SDSCA) questionnaire.
Measured: Before intervention starts.
Change in self-care
Adherence to self-care assessed by the Summary of Diabetes Self-Care Activities (SDSCA) questionnaire.
Measured: In 10th week of intervention or after DFU healing (in ulcers that healed before 10 weeks).
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.
Measured: Before intervention starts.
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.
Measured: In 10th week of intervention or after DFU healing (in ulcers that healed before 10 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start27 Aug 2019
- Primary completion30 Nov 2021
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Piaui
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vinicius Saura Cardoso, Federal University of Piaui
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05071235
- Sponsor's protocol ID
- 3.533.413
- Status last verified
- Feb 2024
- First submitted
- 13 Sep 2021
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05071235
- Acronym / sponsor ID
- 3.533.413
- Conditions
- Diabetic Foot Ulcer, Diabetic Foot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Federal University of PiauiUniversity, hospital or other
- Study start
- 27 Aug 2019 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 8 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CG (control group) + dressing | Placebo comparator | Device: CG (control group), Procedure: DressingThe group will receive placebo LLLT (low-level laser therapy) application associated with Helianthus annuus oil dressing. |
| LG1 (LLLT group 1) + dressing | Active comparator | Device: LG1 (LLLT group 1), Procedure: DressingThe 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 comparator | Device: LG2 (LLLT group 2), Procedure: DressingThe 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 comparator | Device: LG3 (LLLT group 3), Procedure: DressingThe group will receive application of LLLT (low-level laser therapy) Gallium Arsenide (GaAs) 904 nm 4 J/cm² associated with Helianthus annuus oil dressing. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 2 diabetes mellitus patients with diabetic foot ulcers;
- Patients aged 18 to 79 years.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LG1 (LLLT group 1)Application of LLLT (low-level laser therapy) AsGa 904 nm 10 J/cm². | Device | LG1 (LLLT group 1) + dressing |
| LG2 (LLLT group 2)Application of LLLT (low-level laser therapy) AsGa 904 nm 8 J/cm². | Device | LG2 (LLLT group 2) + dressing |
| LG3 (LLLT group 3)Application of LLLT (low-level laser therapy) AsGa 904 nm 4 J/cm². | Device | LG3 (LLLT group 3) + dressing |
| CG (control group)Application of placebo LLLT (low-level laser therapy), that is, with the device turned off. | Device | CG (control group) + dressing |
| DressingApplication of Helianthus annuus oil dressing. | Procedure or surgery | CG (control group) + dressing, LG1 (LLLT group 1) + dressing, LG2 (LLLT group 2) + dressing, LG3 (LLLT group 3) + dressing |
Primary outcome
Initial quality of life (QoL)
Time frame: Before intervention starts.
Quality of life assessed by the SF-36 questionnaire.
Final quality of life (QoL)
Time frame: In 10th week of intervention or after DFU healing (in ulcers that healed before 10 weeks).
Quality of life assessed by the SF-36 questionnaire.
Quality of life (QoL) follow up
Time frame: 1 month after the end of the intervention.
Quality of life assessed by the SF-36 questionnaire.
8 secondary outcomes
Healing time
Time frame: In 10th week of intervention or after DFU healing (in ulcers that healed before 10 weeks).
Percentage of complete healing in 5th week
Time frame: In 5th week of intervention.
Percentage of complete healing in 10th week
Time frame: In 10th week of intervention.
Percentage of complete healing follow up
Time frame: 1 month after the end of the final intervention.
Self-care
Time frame: Before intervention starts.
Change in self-care
Time frame: In 10th week of intervention or after DFU healing (in ulcers that healed before 10 weeks).
Visual analogue scale (VAS)
Time frame: Before intervention starts.
Change in visual analogue scale (VAS)
Time frame: In 10th week of intervention or after DFU healing (in ulcers that healed before 10 weeks).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
Related trials for Diabetic Foot Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LG1 (LLLT group 1), LG2 (LLLT group 2) and LG3 (LLLT group 3) in people with Diabetic Foot Ulcer and Diabetic Foot, run by Federal University of Piaui at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initial quality of life (QoL) (time frame: Before intervention starts.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.