Clinical trial NCT05739214: The Effect of Combined Red and Infrared Lasers on Histopathology Collagen Formation in Diabetic Foot Ulcer
Official title: The Effect of Combined Red and Infrared Lasers on Histopathology Collagen Formation in Diabetic Foot Ulcer: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot
Wound Heal
Collagen Diseases
Keywords: infrared laser
red laser
chronic diabetic foot ulcer
collagen formation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

Brief summary: 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 conventional wound care treatment

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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: percent of collagen formation
timeFrame: two consecutive months
measure: percent of wound size measurement methods
timeFrame: two consecutive months
Secondary outcomes:
measure: percent of wounds complete closure
timeFrame: two consecutive months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Al Kasr Al Aini Teaching Hospital
Study officials:
affiliation: national institute of laser sciences
name: Mahmoud S El Basiouny, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Kasr al aini
name: Heidy F Ahmed, master
role: PRINCIPAL_INVESTIGATOR
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