Diabetic FootwoundsNCT05517863
The Effect of Combined 650 nm and Infrared Laser on Chronic Diabetic Foot Ulcer Surface Area:
A study testing laser therapy in people with Diabetic Foot and Wound Heal, run by Heidy F. Ahmed at 1 site in Egypt.
Trial summary
Objective: investigate the effect of combined 650 nm and infrared laser on chronic diabetic foot ulcer surface area. Participants: The forty five patients will assigned randomly into three equal groups, each group consist of 15 patients, group A received laser therapy in sequential mode, group B received laser therapy… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Foot, Wound Heal
- What is being tested?
- laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2022to 27 Jul 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1- Diabetic patients with either type I or II 2- Age from 18-60 years old, both sexes 3- Ulcer lasting longer than two months 4- DFU grade 1 or 2 according to Wagner classification. 5- All patients able to walk dependently
Who cannot join
- Patients with vascular disease
- Patients with fixed ankle deformity as Charcot foot or stiffness
- Patients with any type of osteomyelitis associated with DFU
- Patients with renal or hepatic failure
- BMI < 30 kg/m2 as Obesity can cause poor perfusion due to vascular insufficiencies; altered population of immune mediators may lengthen the inflammatory process \& decrease oxygenation of subcutaneous adipose tissue which is liable to be infected.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Combined 650 nm and Infrared Laser on Chronic Diabetic Foot Ulcer Surface Area: a Randomized Controlled Trial
Objective: investigate the effect of combined 650 nm and infrared laser on chronic diabetic foot ulcer surface area.
Participants: The forty five patients will assigned randomly into three equal groups, each group consist of 15 patients, group A received laser therapy in sequential mode, group B received laser therapy in separate mode and the control group C receive traditional wound care
Read the detailed description
Objective: investigate the effect of combined 650 nm and infrared laser on chronic diabetic foot ulcer surface area.
Participants: The forty five patients will assigned randomly into three equal groups, each group consist of 15 patients, group A received laser therapy in sequential mode, group B received laser therapy in separate mode and the control group C receive traditional wound care Outcomes: the primary outcomes were the wound surface area measurement, % of wound complete closure and % of days needed for surface area reduction before and after receiving the treatment protocol for two consequetive months, and the secondary outcomes were % of wound cause and location frequencies
- Conditions
- Diabetic Foot, Wound Heal
- Being tested
- laser therapy
- Keywords
- 650 nm laser, infrared laser, chronic diabetic foot ulcer, wound surface area
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser therapyDevice
All patients received 2 sessions of laser therapy / week in two consecutive months of treatment aiming complete wound closure , patients received \& infrared laser therapy plus traditional wound care:
(I) Use red \& infrared laser therapy device with 4 different wavelengths in a synchronized mode:
- 980 nm for wound decontamination, improve circulation, lymphatic drainage
- 915 nm enhances O2 delivery
- 810 nm increases ATP production
- 650 nm accelerate surface healing, tissue regeneration plus traditional wound treatment mentioned before
| Study group | Role | What they receive |
|---|---|---|
| laser sequential mode | Experimental | All patients received 2 sessions of laser therapy / week with different wavelengths in sequential mode in two consecutive months of treatment aiming complete wound closure , patients received \& infrared laser therapy plus traditional wound care Receives: Device: laser therapy |
| laser seperate mode | Experimental | All patients received 2 sessions of laser therapy / week with different wavelengths in seperate mode in two consecutive months of treatment aiming complete wound closure , patients received \& infrared laser therapy plus traditional wound care Receives: Device: laser therapy |
| traditional wound care | Active comparator | (II) Traditional wound care inform of
1. Wound care treatment
* Debridement to remove necrotic tissue
* Irrigation of the wound by normal saline
* Change dressing daily to protect wound from infection
2. Foot care
* Wash feet daily, dry carefully especially between toe
* Avoid extreme temperatures
* Inspection daily of foot blisters
3. Foot wear
* Avoid walking bare foot
* Properly fitted shoes
* Avoid wearing open-toed shoes Receives: Device: laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
percent of wound size measurement methods
weekly by
- a ruler (wound area was calculated by measuring and multiplying the greatest length by the greatest width perpendicular to the greatest length)
- a sterile transparent film sheet
Measured: two consecutive months
percent of wounds complete closure
measure percent of wounds complete closure in each group
Measured: two consecutive months
Secondary outcomes (3)
percent of each type of wound cause
different wound cause diabetic foot ulcers and healing time
Measured: two consecutive months
percent of each wound location
different wound location in diabetic foot ulcers and healing time
Measured: two consecutive months
percent of days needed for surface area reduction
measure the days needed to decrease surface area in each group
Measured: two consecutive months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start1 Mar 2022
- Primary completion12 Jul 2022
- Study completion27 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Diabetic FootStudies 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
- Model description
- group A received laser therapy in sequential mode, group B received laser therapy in separate mode and the control group C receive traditional wound care
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidy F. Ahmed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Heidy F. Ahmed, Cairo University
- Investigators
- Mahmoud S El Basiouny, Principal investigator, national institute of laser sciencesHeidy F Ahmed, master, Principal investigator, Kasr al aini
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05517863
- Sponsor's protocol ID
- LASER.REC/2022
- Acronym
- wounds
- Status last verified
- Oct 2023
- First submitted
- 24 Aug 2022
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected individual participant data (IPD), all IPD that underline results in a publication.
Publications
Experimental Study of the Effect of Photobiomodulation Therapy on the Regulation of the Healing Process of Chronic Wounds
Hamblin, M. R., Agrawal, T., & de Sousa, M. (Eds.). (2016). Handbook of low-level laser therapy. CRC Press.
Rupel K, Zupin L, Colliva A, Kamada A, Poropat A, Ottaviani G, Gobbo M, Fanfoni L, Gratton R, Santoro M, Di Lenarda R, Biasotto M, Zacchigna S. Photobiomodulation at Multiple Wavelengths Differentially Modulates Oxidative Stress In Vitro and In Vivo. Oxid Med Cell Longev. 2018 Nov 11;2018:6510159. doi: 10.1155/2018/6510159. eCollection 2018.
PubMed 30534349Lima AMCT, da Silva Sergio LP, de Souza da Fonseca A. Photobiomodulation via multiple-wavelength radiations. Lasers Med Sci. 2020 Mar;35(2):307-316. doi: 10.1007/s10103-019-02879-1. Epub 2019 Sep 16.
PubMed 31523781Mosca RC, Ong AA, Albasha O, Bass K, Arany P. Photobiomodulation Therapy for Wound Care: A Potent, Noninvasive, Photoceutical Approach. Adv Skin Wound Care. 2019 Apr;32(4):157-167. doi: 10.1097/01.ASW.0000553600.97572.d2.
PubMed 30889017Leyane TS, Jere SW, Houreld NN. Cellular Signalling and Photobiomodulation in Chronic Wound Repair. Int J Mol Sci. 2021 Oct 18;22(20):11223. doi: 10.3390/ijms222011223.
PubMed 34681882de Sousa AP, Paraguassu GM, Silveira NT, de Souza J, Cangussu MC, dos Santos JN, Pinheiro AL. Laser and LED phototherapies on angiogenesis. Lasers Med Sci. 2013 May;28(3):981-7. doi: 10.1007/s10103-012-1187-z. Epub 2012 Aug 25.
PubMed 22923269Moskvin SV, Geynitz AV, Askhadulin EV. Efficiency of a New Combined Laser Therapy in Patients With Trophic Ulcers of Lower Extremities and Chronic Venous Insufficiency. J Lasers Med Sci. 2017 Summer;8(3):132-135. doi: 10.15171/jlms.2017.24. Epub 2017 Jun 27.
PubMed 29123633de Lima FJ, Barbosa FT, de Sousa-Rodrigues CF. Use alone or in Combination of Red and Infrared Laser in Skin Wounds. J Lasers Med Sci. 2014 Spring;5(2):51-7.
PubMed 25653799Santos NR, de M Sobrinho JB, Almeida PF, Ribeiro AA, Cangussu MC, dos Santos JN, Pinheiro AL. Influence of the combination of infrared and red laser light on the healing of cutaneous wounds infected by Staphylococcus aureus. Photomed Laser Surg. 2011 Mar;29(3):177-82. doi: 10.1089/pho.2009.2749. Epub 2011 Jan 8.
PubMed 21214389
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Combined 650 nm and Infrared Laser on Chronic Diabetic Foot Ulcer Surface Area: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05517863
- Acronym / sponsor ID
- wounds / LASER.REC/2022
- Conditions
- Diabetic Foot, Wound Heal
- Keywords
- 650 nm laser, infrared laser, chronic diabetic foot ulcer, wound surface area
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Heidy F. AhmedUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 12 Jul 2022 (actual)
- Study completion
- 27 Jul 2022 (actual)
- First posted
- 26 Aug 2022 (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.
Objective: investigate the effect of combined 650 nm and infrared laser on chronic diabetic foot ulcer surface area.
Participants: The forty five patients will assigned randomly into three equal groups, each group consist of 15 patients, group A received laser therapy in sequential mode, group B received laser therapy in separate mode and the control group C receive traditional wound care
Detailed description
Objective: investigate the effect of combined 650 nm and infrared laser on chronic diabetic foot ulcer surface area.
Participants: The forty five patients will assigned randomly into three equal groups, each group consist of 15 patients, group A received laser therapy in sequential mode, group B received laser therapy in separate mode and the control group C receive traditional wound care Outcomes: the primary outcomes were the wound surface area measurement, % of wound complete closure and % of days needed for surface area reduction before and after receiving the treatment protocol for two consequetive months, and the secondary outcomes were % of wound cause and location frequencies
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- group A received laser therapy in sequential mode, group B received laser therapy in separate mode and the control group C receive traditional wound care
| Arm | Type | Receives |
|---|---|---|
| laser sequential mode | Experimental | Device: laser therapyAll patients received 2 sessions of laser therapy / week with different wavelengths in sequential mode in two consecutive months of treatment aiming complete wound closure , patients received \& infrared laser therapy plus traditional wound care |
| laser seperate mode | Experimental | Device: laser therapyAll patients received 2 sessions of laser therapy / week with different wavelengths in seperate mode in two consecutive months of treatment aiming complete wound closure , patients received \& infrared laser therapy plus traditional wound care |
| traditional wound care | Active comparator | Device: laser therapy(II) Traditional wound care inform of 1. Wound care treatment * Debridement to remove necrotic tissue * Irrigation of the wound by normal saline * Change dressing daily to protect wound from infection 2. Foot care * Wash feet daily, dry carefully especially between toe * Avoid extreme temperatures * Inspection daily of foot blisters 3. Foot wear * Avoid walking bare foot * Properly fitted shoes * Avoid wearing open-toed shoes |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1- Diabetic patients with either type I or II 2- Age from 18-60 years old, both sexes 3- Ulcer lasting longer than two months 4- DFU grade 1 or 2 according to Wagner classification. 5- All patients able to walk dependently
Key exclusion criteria (5 listed)
- Patients with vascular disease
- Patients with fixed ankle deformity as Charcot foot or stiffness
- Patients with any type of osteomyelitis associated with DFU
- Patients with renal or hepatic failure
- BMI < 30 kg/m2 as Obesity can cause poor perfusion due to vascular insufficiencies; altered population of immune mediators may lengthen the inflammatory process \& decrease oxygenation of subcutaneous adipose tissue which is liable to be infected.
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 |
|---|---|---|
| laser therapyAll patients received 2 sessions of laser therapy / week in two consecutive months of treatment aiming complete wound closure , patients received \& infrared laser therapy plus traditional wound care: (I) Use red \& infrared laser therapy device with 4 different wavelengths in a synchronized mode: 1. 980 nm for wound decontamination, improve circulation, lymphatic drainage 2. 915 nm enhances O2 delivery 3. 810 nm increases ATP production 4. 650 nm accelerate surface healing, tissue regeneration plus traditional wound treatment mentioned before | Device | laser seperate mode, laser sequential mode, traditional wound care |
Primary outcome
percent of wound size measurement methods
Time frame: two consecutive months
weekly by 1. a ruler (wound area was calculated by measuring and multiplying the greatest length by the greatest width perpendicular to the greatest length) 2. a sterile transparent film sheet
percent of wounds complete closure
Time frame: two consecutive months
measure percent of wounds complete closure in each group
3 secondary outcomes
percent of each type of wound cause
Time frame: two consecutive months
percent of each wound location
Time frame: two consecutive months
percent of days needed for surface area reduction
Time frame: two consecutive months
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 23 Oct 2023.
- BackgroundExperimental Study of the Effect of Photobiomodulation Therapy on the Regulation of the Healing Process of Chronic Wounds
- BackgroundHamblin, M. R., Agrawal, T., & de Sousa, M. (Eds.). (2016). Handbook of low-level laser therapy. CRC Press.
- Background: PubMed 30534349Rupel K, Zupin L, Colliva A, Kamada A, Poropat A, Ottaviani G, Gobbo M, Fanfoni L, Gratton R, Santoro M, Di Lenarda R, Biasotto M, Zacchigna S. Photobiomodulation at Multiple Wavelengths Differentially Modulates Oxidative Stress In Vitro and In Vivo. Oxid Med Cell Longev. 2018 Nov 11;2018:6510159. doi: 10.1155/2018/6510159. eCollection 2018.
- Background: PubMed 31523781Lima AMCT, da Silva Sergio LP, de Souza da Fonseca A. Photobiomodulation via multiple-wavelength radiations. Lasers Med Sci. 2020 Mar;35(2):307-316. doi: 10.1007/s10103-019-02879-1. Epub 2019 Sep 16.
- Background: PubMed 30889017Mosca RC, Ong AA, Albasha O, Bass K, Arany P. Photobiomodulation Therapy for Wound Care: A Potent, Noninvasive, Photoceutical Approach. Adv Skin Wound Care. 2019 Apr;32(4):157-167. doi: 10.1097/01.ASW.0000553600.97572.d2.
- Background: PubMed 34681882Leyane TS, Jere SW, Houreld NN. Cellular Signalling and Photobiomodulation in Chronic Wound Repair. Int J Mol Sci. 2021 Oct 18;22(20):11223. doi: 10.3390/ijms222011223.
- Background: PubMed 22923269de Sousa AP, Paraguassu GM, Silveira NT, de Souza J, Cangussu MC, dos Santos JN, Pinheiro AL. Laser and LED phototherapies on angiogenesis. Lasers Med Sci. 2013 May;28(3):981-7. doi: 10.1007/s10103-012-1187-z. Epub 2012 Aug 25.
- Background: PubMed 29123633Moskvin SV, Geynitz AV, Askhadulin EV. Efficiency of a New Combined Laser Therapy in Patients With Trophic Ulcers of Lower Extremities and Chronic Venous Insufficiency. J Lasers Med Sci. 2017 Summer;8(3):132-135. doi: 10.15171/jlms.2017.24. Epub 2017 Jun 27.
- Background: PubMed 25653799de Lima FJ, Barbosa FT, de Sousa-Rodrigues CF. Use alone or in Combination of Red and Infrared Laser in Skin Wounds. J Lasers Med Sci. 2014 Spring;5(2):51-7.
- Background: PubMed 21214389Santos NR, de M Sobrinho JB, Almeida PF, Ribeiro AA, Cangussu MC, dos Santos JN, Pinheiro AL. Influence of the combination of infrared and red laser light on the healing of cutaneous wounds infected by Staphylococcus aureus. Photomed Laser Surg. 2011 Mar;29(3):177-82. doi: 10.1089/pho.2009.2749. Epub 2011 Jan 8.
- Individual participant dataSharing planned: Yes. All collected individual participant data (IPD), all IPD that underline results in a publication.
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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.
Mahmoud S El Basiouny principal investigator
national institute of laser sciences
Heidy F Ahmed, master principal investigator
Kasr al aini
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laser therapy in people with Diabetic Foot and Wound Heal, run by Heidy F. Ahmed at 1 site in Egypt.
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 1 inclusion and 5 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 23 Oct 2023. 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 Egypt. 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. 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?
percent of wound size measurement methods (time frame: two consecutive months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05517863, which also lists 10 linked publications.
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 23 Oct 2023.