Cairo University
Cairo, Egypt, 12613
NCT Number: NCT06827171
Diabetes is one of the fastest-growing diseases worldwide, It has Devastating macrovascular complications (cardiovascular disease) and microvascular complications (such as diabetic kidney disease, diabetic retinopathy, and neuropathy) In Egypt, factors in patients that affect diabetic control include the patient's education and occupation and smoking status. Physical exercise is important for diabetes control. Metformin and investigation availability have a positive association with diabetes control.
Diabetes mellitus increases the risk and accelerates the course of peripheral artery disease, making patients more susceptible to ischemic events and infections and delaying tissue healing. The current understanding of pathogenic mechanisms is mainly based on the negative influence of diabetes mellitus on atherosclerotic disease and inflammation (Fadini et al., 2020).) An early diagnosis of peripheral arterial diseases PAD and correctly identifying patients with Chronic limb-threatening ischemia CLTI are crucial in patients with diabetes to improve outcomes.
Several treatment strategies can be subdivided into lifestyle modification, medical management, endovascular therapies, and surgical interventions for the treatment of PAD.
Exercise training improves walking ability, distances, physical function, and vitality. Physical activity by supervised exercise is recommended in first-line therapy for intermittent claudication by SVS, ESVS, and AHA (Treat-Jacobson et al., 219) More specifically, a supervised exercise program consists of walking a minimum of three times per week (30-60 min/session) for at least 12 weeks Therapeutic laser treatment, also known as low-level laser therapy (LLLT), offers numerous benefits. It is non-surgical, promotes tissue healing, and reduces edema, inflammation, and pain.
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Notify Me55 year–65 year
All sexes
Interventional
Phase 2
Cairo, Egypt, 12613
The participants will be submitted into two equal groups in numbers:
Group A (Study group) n=20 will receive a low-level laser (scanning laser) combined with an aerobic exercise program for 12 weeks (3 sessions/ week).
Group B (control group) n=20: Who will receive aerobic exercise for 12 weeks (3sessions/week) All patients with their prescribed medications (hypoglycemic, antiplatelet, anticoagulants, antihypertensive, vasodilators, analgesics)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
low- level laser parameters: The wavelength: 808 +/- 5nm The power: output is 450 Mw Type of beam: red laser beam. Beam Divergent >,025 rad+/- ,005rad Nominal Distance of Sight hazard >8m The duration: is 20 min for each artery. Treatment period: 3 times/week for 3 months.
Aerobic exercise Frequency = 3sessions/week duration: 10 min warm up and 10 min cool down/ 30 min stance phase Intensity: moderate intensity initiating with 50% HR max to end 75% HR max
Time frame: 3 month
Body mass index (Kg/M^2): by dividing the weight by kilogram over Height by meter square.
Time frame: 3 months
Duplex ultrasonography of the lower extremity arteries, from common femoral to pedal arteries is used to measure PSV
Severe arterial disease manifests as a PSV over 200 cm/s, monophasic waveform, and spectral broadening of the Doppler waveform.
Time frame: 3 months
An ABI < 0.9 was diagnostic of PAD and values were stratified according to severity as:
Time frame: 3 months
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." Delgado etal., 2018).
Time frame: 3 months
The Edinburgh Claudication Questionnaire (ECQ) Definition of positive classification requires all of the following responses: \\Yes" to (1), \\No" to (2), \\Yes" to (3), Grade 1 \\No" to (4), and Grade 2 \\Yes" to (4). If these criteria are met, a typical claudicant is one who indicates the pain is in the calf, regardless of whether the pain is also marked at other sites; a diagnosis of atypical claudication is made when the pain is marked in the thigh or buttock, in the absence of any calf pain. Subjects should not be diagnosed with claudication if the pain is indicated in the hamstrings, feet, shins, and joints, or radiates in the absence of any calf pain
Time frame: 3 months
The initial claudication distance (ICD), or pain-free walking distance; is the distance walked at the onset of claudication pain The absolute claudication distance (ACD), or maximal walking distance at which claudication pain becomes so severe that the patient is forced to stop (Jongert et al., 2003)
Time frame: 3 months
depend on Modified Bruce protocol with the treadmill. Modified Bruce protocol, the first stage at 1.7mph and 0% grade second stage at 1.7 mph 5% grade, and the third stage at 1.7 mph and 10% grade.
The test score is the time taken on the test, in minutes. This can also be converted to an estimated VO2 max score using the calculator below and the following formulas, where the value "T" is the total time completed (expressed in minutes and fractions of a minute e.g. 9 minutes 25 seconds = 9.25 minutes).
Men : VO2max (ml/kg/min) = 14.76 -(1.379 × T) + (0.451 × T²)-(0.012 × T³) Women: VO2max (ml/kg/min) = 4.38x T -3.9 (ACSM, 2023)
Nouran Hesham Slama Younis
Other
Impact of Low-level Laser and Aerobic Exercise on Peripheral Arterial Outcomes in Patients With Type 2 Diabetes
Acronym: LLLT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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