An interventional study of laser therapy in Diabetic Foot and Wound Heal, sponsored by Heidy F. Ahmed. Completed at 1 site in Egypt. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-23.
Sponsored by Heidy F. Ahmed · Not applicable, Interventional, and Treatment
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
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
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's enrollment of 45 is below the median of 60 across 826 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Heidy F. Ahmed is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Device: laser therapy
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
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
Device: laser therapy
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
percent of wound size measurement methods
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
Time frame: two consecutive months
percent of wounds complete closure
measure percent of wounds complete closure in each group
Time frame: two consecutive months
percent of each type of wound cause
different wound cause diabetic foot ulcers and healing time
Time frame: two consecutive months
percent of each wound location
different wound location in diabetic foot ulcers and healing time
Time frame: two consecutive months
percent of days needed for surface area reduction
measure the days needed to decrease surface area in each group
Time frame: two consecutive months
Plan to share: Yes — All collected individual participant data (IPD), all IPD that underline results in a publication.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Heidy F. Ahmed