Diabetic FootwoundsNCT05739214

The Effect of Combined Red and Infrared Lasers on Histopathology Collagen Formation in Diabetic Foot Ulcer

A study testing laser therapy in people with Diabetic Foot and Wound Heal, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Diabetic Foot, Wound Heal, Collagen Diseases
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 Aug 2022to 28 Jan 2023
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 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

aged between 18 and 60 years; both gender; Diabetic patients type II; Ulcer lasting longer than two months; diabetic foot ulcer (DFU) grade 1 (Superficial diabetic ulcer, ulcer limited to the dermis, not extending to the subcutis) or grade 2 (Ulcer of the skin extending through the subcutis with exposed tendon or bone and without osteomyelitis or abscess formation) according to the Wagner classification

Who cannot join

Patients with fixed ankle deformity as Charcot foot or stiffness; Patients with any type of osteomyelitis associated with DFU; the presence of active infection requiring hospitalization, gangrene, systemic diseases such as collagen-vascular diseases, renal failure, evidence of ischemia; BMI < 30 kg/m2 as Obesity can cause poor perfusion due to vascular insufficiencies; an 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.

Egypt1 site

Al Kasr Al Aini Teaching Hospital
Giza, 12556

Other trials in Egypt

About this study

Official title: The Effect of Combined Red and Infrared Lasers on Histopathology Collagen Formation in Diabetic Foot Ulcer: a Randomized Controlled Trial

Read the detailed description

Objective: investigate The effect of combined red and infrared lasers on histopathology collagen formation in diabetic foot ulcer 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 collage formation before and after receiving the treatment protocol for two consequetive months

Conditions: Diabetic Foot, Wound Heal, Collagen Diseases
Being tested: laser therapy
Keywords: infrared laser, red laser, chronic diabetic foot ulcer, collagen formation
Medical subject headings: Diabetic Foot, Collagen Diseases

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:
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

Study groups in NCT05739214
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	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 collagen formation
by histological pictures
Measured: two consecutive months
percent of wound size measurement methods
measure percent of wounds decrease surface area
Measured: two consecutive months

Secondary outcomes (1)

percent of wounds complete closure
measure percent of wounds complete closure 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.

1 Aug 202228 Jan 2023

First posted22 Feb 2023
Study start1 Aug 2022
Primary completion6 Jan 2023
Study completion28 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (18)Papers the sponsor has linked to this study.
Other trials for Diabetic FootStudies of the same condition, open and under way.
More trials run by Cairo UniversityThe sponsor's other registered studies.
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 conventional wound care treatment
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05739214
Sponsor's protocol ID: NILES-EC-CU 23/3/3
Acronym: wounds
Status last verified: Oct 2023
First submitted: 13 Feb 2023
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

Hegazi R, El-Gamal M, Abdel-Hady N, Hamdy O. Epidemiology of and Risk Factors for Type 2 Diabetes in Egypt. Ann Glob Health. 2015 Nov-Dec;81(6):814-20. doi: 10.1016/j.aogh.2015.12.011.
PubMed 27108148
Banik PC, Barua L, Moniruzzaman M, Mondal R, Zaman F, Ali L. Risk of diabetic foot ulcer and its associated factors among Bangladeshi subjects: a multicentric cross-sectional study. BMJ Open. 2020 Feb 28;10(2):e034058. doi: 10.1136/bmjopen-2019-034058.
PubMed 32114471
American Diabetes Association. Peripheral arterial disease in people with diabetes. Diabetes Care. 2003 Dec;26(12):3333-41. doi: 10.2337/diacare.26.12.3333. No abstract available.
PubMed 14633825
Vinik AI, Erbas T, Park TS, Nolan R, Pittenger GL. Platelet dysfunction in type 2 diabetes. Diabetes Care. 2001 Aug;24(8):1476-85. doi: 10.2337/diacare.24.8.1476.
PubMed 11473089
Sorensen MLB, Jansen RB, Wilbek Fabricius T, Jorgensen B, Svendsen OL. Healing of Diabetic Foot Ulcers in Patients Treated at the Copenhagen Wound Healing Center in 1999/2000 and in 2011/2012. J Diabetes Res. 2019 Sep 8;2019:6429575. doi: 10.1155/2019/6429575. eCollection 2019.
PubMed 31583251
American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2009 Jan;32 Suppl 1(Suppl 1):S62-7. doi: 10.2337/dc09-S062. No abstract available.
PubMed 19118289
Cunha JLS, Carvalho FMA, Pereira Filho RN, Ribeiro MAG, de Albuquerque-Junior RLC. Effects of Different Protocols of Low-Level Laser Therapy on Collagen Deposition in Wound Healing. Braz Dent J. 2019 Jul 22;30(4):317-324. doi: 10.1590/0103-6440201902400.
PubMed 31340220
8) Brandão, M. G. S. A., Ximenes, M. A. M., de Oliveira Ramalho, A., Veras, V. S., Barros, L. M., & de Araújo, T. M. (2020). Effects of low-level laser therapy on the healing of foot ulcers in people with diabetes mellitus. Estima-Brazilian Journal of Enterostomal Therapy, 18, e320.
Oyebode O, Houreld NN, Abrahamse H. Photobiomodulation in diabetic wound healing: A review of red and near-infrared wavelength applications. Cell Biochem Funct. 2021 Jul;39(5):596-612. doi: 10.1002/cbf.3629. Epub 2021 Apr 18.
PubMed 33870502
Coerper S, Wicke C, Pfeffer F, Koveker G, Becker HD. Documentation of 7051 chronic wounds using a new computerized system within a network of wound care centers. Arch Surg. 2004 Mar;139(3):251-8. doi: 10.1001/archsurg.139.3.251.
PubMed 15006880
Pierpont YN, Dinh TP, Salas RE, Johnson EL, Wright TG, Robson MC, Payne WG. Obesity and surgical wound healing: a current review. ISRN Obes. 2014 Feb 20;2014:638936. doi: 10.1155/2014/638936. eCollection 2014.
PubMed 24701367
Kaviani A, Djavid GE, Ataie-Fashtami L, Fateh M, Ghodsi M, Salami M, Zand N, Kashef N, Larijani B. A randomized clinical trial on the effect of low-level laser therapy on chronic diabetic foot wound healing: a preliminary report. Photomed Laser Surg. 2011 Feb;29(2):109-14. doi: 10.1089/pho.2009.2680. Epub 2011 Jan 9.
PubMed 21214368
Goralczyk K, Szymanska J, Szot K, Fisz J, Rosc D. Low-level laser irradiation effect on endothelial cells under conditions of hyperglycemia. Lasers Med Sci. 2016 Jul;31(5):825-31. doi: 10.1007/s10103-016-1880-4. Epub 2016 Feb 9.
PubMed 26861982
Ayuk SM, Houreld NN, Abrahamse H. Collagen production in diabetic wounded fibroblasts in response to low-intensity laser irradiation at 660 nm. Diabetes Technol Ther. 2012 Dec;14(12):1110-7. doi: 10.1089/dia.2012.0125. Epub 2012 Oct 11.
PubMed 23057714
Broughton G 2nd, Janis JE, Attinger CE. The basic science of wound healing. Plast Reconstr Surg. 2006 Jun;117(7 Suppl):12S-34S. doi: 10.1097/01.prs.0000225430.42531.c2.
PubMed 16799372

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Diabetic Foot trials

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 Red and Infrared Lasers on Histopathology Collagen Formation in Diabetic Foot Ulcer: a Randomized Controlled Trial
ClinicalTrials.gov ID: NCT05739214
Acronym / sponsor ID: wounds / NILES-EC-CU 23/3/3
Conditions: Diabetic Foot, Wound Heal, Collagen Diseases
Keywords: infrared laser, red laser, chronic diabetic foot ulcer, collagen formation
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: Cairo UniversityUniversity, hospital or other
Study start: 1 Aug 2022 (actual)
Primary completion: 6 Jan 2023 (actual)
Study completion: 28 Jan 2023 (actual)
First posted: 22 Feb 2023 (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.

Detailed description

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 conventional wound care treatment

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 therapyTraditional 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: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

aged between 18 and 60 years; both gender; Diabetic patients type II; Ulcer lasting longer than two months; diabetic foot ulcer (DFU) grade 1 (Superficial diabetic ulcer, ulcer limited to the dermis, not extending to the subcutis) or grade 2 (Ulcer of the skin extending through the subcutis with exposed tendon or bone and without osteomyelitis or abscess formation) according to the Wagner classification

Key exclusion criteria (1 listed)

Patients with fixed ankle deformity as Charcot foot or stiffness; Patients with any type of osteomyelitis associated with DFU; the presence of active infection requiring hospitalization, gangrene, systemic diseases such as collagen-vascular diseases, renal failure, evidence of ischemia; BMI < 30 kg/m2 as Obesity can cause poor perfusion due to vascular insufficiencies; an 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 collagen formation
Time frame: two consecutive months
by histological pictures
percent of wound size measurement methods
Time frame: two consecutive months
measure percent of wounds decrease surface area

1 secondary outcome

percent of wounds complete closure
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.
Background: PubMed 27108148Hegazi R, El-Gamal M, Abdel-Hady N, Hamdy O. Epidemiology of and Risk Factors for Type 2 Diabetes in Egypt. Ann Glob Health. 2015 Nov-Dec;81(6):814-20. doi: 10.1016/j.aogh.2015.12.011.
Background: PubMed 32114471Banik PC, Barua L, Moniruzzaman M, Mondal R, Zaman F, Ali L. Risk of diabetic foot ulcer and its associated factors among Bangladeshi subjects: a multicentric cross-sectional study. BMJ Open. 2020 Feb 28;10(2):e034058. doi: 10.1136/bmjopen-2019-034058.
Background: PubMed 14633825American Diabetes Association. Peripheral arterial disease in people with diabetes. Diabetes Care. 2003 Dec;26(12):3333-41. doi: 10.2337/diacare.26.12.3333. No abstract available.
Background: PubMed 11473089Vinik AI, Erbas T, Park TS, Nolan R, Pittenger GL. Platelet dysfunction in type 2 diabetes. Diabetes Care. 2001 Aug;24(8):1476-85. doi: 10.2337/diacare.24.8.1476.
Background: PubMed 31583251Sorensen MLB, Jansen RB, Wilbek Fabricius T, Jorgensen B, Svendsen OL. Healing of Diabetic Foot Ulcers in Patients Treated at the Copenhagen Wound Healing Center in 1999/2000 and in 2011/2012. J Diabetes Res. 2019 Sep 8;2019:6429575. doi: 10.1155/2019/6429575. eCollection 2019.
Background: PubMed 19118289American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2009 Jan;32 Suppl 1(Suppl 1):S62-7. doi: 10.2337/dc09-S062. No abstract available.
Background: PubMed 31340220Cunha JLS, Carvalho FMA, Pereira Filho RN, Ribeiro MAG, de Albuquerque-Junior RLC. Effects of Different Protocols of Low-Level Laser Therapy on Collagen Deposition in Wound Healing. Braz Dent J. 2019 Jul 22;30(4):317-324. doi: 10.1590/0103-6440201902400.
Background8) Brandão, M. G. S. A., Ximenes, M. A. M., de Oliveira Ramalho, A., Veras, V. S., Barros, L. M., & de Araújo, T. M. (2020). Effects of low-level laser therapy on the healing of foot ulcers in people with diabetes mellitus. Estima-Brazilian Journal of Enterostomal Therapy, 18, e320.
Background: PubMed 33870502Oyebode O, Houreld NN, Abrahamse H. Photobiomodulation in diabetic wound healing: A review of red and near-infrared wavelength applications. Cell Biochem Funct. 2021 Jul;39(5):596-612. doi: 10.1002/cbf.3629. Epub 2021 Apr 18.
Background: PubMed 15006880Coerper S, Wicke C, Pfeffer F, Koveker G, Becker HD. Documentation of 7051 chronic wounds using a new computerized system within a network of wound care centers. Arch Surg. 2004 Mar;139(3):251-8. doi: 10.1001/archsurg.139.3.251.
Background: PubMed 24701367Pierpont YN, Dinh TP, Salas RE, Johnson EL, Wright TG, Robson MC, Payne WG. Obesity and surgical wound healing: a current review. ISRN Obes. 2014 Feb 20;2014:638936. doi: 10.1155/2014/638936. eCollection 2014.
Background: PubMed 21214368Kaviani A, Djavid GE, Ataie-Fashtami L, Fateh M, Ghodsi M, Salami M, Zand N, Kashef N, Larijani B. A randomized clinical trial on the effect of low-level laser therapy on chronic diabetic foot wound healing: a preliminary report. Photomed Laser Surg. 2011 Feb;29(2):109-14. doi: 10.1089/pho.2009.2680. Epub 2011 Jan 9.
Individual participant dataSharing planned: Yes. All collected individual participant data (IPD), all IPD that underline results in a publication.

Related trials for Diabetic Foot

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.

Mahmoud S El Basiouny, professor 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 Cairo University 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 1 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 collagen formation (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 NCT05739214, which also lists 18 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.