Impact of LLL and Aerobic Exercise on Peripheral Arterial Outcomes in Patients With Type 2 Diabetes

NCT06827171 | Completed Phase 2 DMC FDA Device

• 1 other identifier: P.T.REC/012/004935
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Keywords

Peripheral artery Disease; Low level laser; Aerobic exercise

Outcome Measures

Primary Outcomes (5)

• body mass index

  Body mass index (Kg/M\^2): by dividing the weight by kilogram over Height by meter square.

  3 month

• peak systolic velocities (PSV)

  Duplex ultrasonography of the lower extremity arteries, from common femoral to pedal arteries is used to measure PSV * Peak systolic velocities (PSV) were recorded in meters per second (Ugwu et al., 2021). * The normal peak systolic velocity (PSV) in peripheral lower limb arteries varies from 45-180 cm/s (Abdelrahman, 2010). Severe arterial disease manifests as a PSV over 200 cm/s, monophasic waveform, and spectral broadening of the Doppler waveform.

  3 months

• Ankle-Brachial Index (ABI) %

  • Ankle-Brachial Index (ABI) is a ratio of the highest ankle systolic blood pressure obtained in the anterior tibial/ dorsalis pedis or posterior tibial artery to that of the highest brachial systolic pressure. An ABI \< 0.9 was diagnostic of PAD and values were stratified according to severity as: * 0.7-0.89 = mild arterial obstruction. * 0.5-0.69 = moderate arterial obstruction. * ≤ 0.5 = severe arterial obstruction.

  3 months

• The visual analog scale (VAS) questionnaire for pain

  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). * no pain (0-4 mm) * mild pain(5-44 mm) * moderate pain (45-74 mm) * severe pain (75-100 mm). (Weigl K et al., 2021)

  3 months

• The Edinburgh Claudication Questionnaire (ECQ)

  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

  3 months

Secondary Outcomes (2)

• The initial claudication distance and The absolute claudication distance (meters)

  3 months

• Maximum oxygen consumption Vo^2 max ((ml/kg/min))

  3 months

Study Arms (2)

Study group A: Aerobic exercise+ low-level Laser therapy

EXPERIMENTAL

(Study group A): It will receive a low-level laser (scanning laser) on the course of the posterior tibial and anterior tibial artery combined with an aerobic exercise program for peripheral artery disorder for 12 weeks (3 sessions/ week).

Combination Product: aerobic exercise + low-level laser therapy; Other: Aerobic exercise

Control group B: Aerobic Exercise group B

EXPERIMENTAL

group B: They will receive aerobic exercise for 12 weeks. aerobic exercise program for peripheral arterial disorders and intermittent claudication.

Other: Aerobic exercise

Interventions

aerobic exercise + low-level laser therapy COMBINATION_PRODUCT

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.

Study group A: Aerobic exercise+ low-level Laser therapy

Aerobic exercise OTHER

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

Control group B: Aerobic Exercise group B; Study group A: Aerobic exercise+ low-level Laser therapy

Eligibility Criteria

• Age: 55 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Their ages will range from 55- 65 years, for both genders.
• Body Mass Index of 25-29.9kg/m2.
• Glycated hemoglobin (HbA1c) from 7 to 9 %.
• The patient has suffered from diabetes for more than 5 years.
• Patient with mild to moderate PAD on Rutherford classification stages (1-3)

You may not qualify if:

• Patients with a history of hypo-hyperglycemic coma.
• Uncontrolled cardiovascular complications, and ischemic heart disease.
• Photosensitivity, Malignancy, Anemia, Hemorrhagic diseases (contraindication to laser)
• Deep venous thrombosis, acute thromboses.
• Cerebrovascular disease.
• Patients with Monckeberg sclerosis.
• Patient with resting pain critical limb ischemia, diabetic foot, and peripheral edema, asymptomatic PAD, Diabetic neuropathy.
• Patient with minor/ or major amputations.
• A patient with positive smoking

Sponsors & Collaborators

• Nouran Hesham Slama Younis: lead

Study Sites (1)

Cairo University

Cairo, Egypt, 12613, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Peripheral Arterial Disease

Interventions

Exercise; Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Nesreen Gh EL NAHAS, doctor

  head of physical therapy department for internal medicine, Cairo university.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical investigator, police hospital, Egypt

Model Details: the study is going to contain 2 experimental groups, the first one will receive combined therapy (aerobic exercise program for PAD + low-level laser therapy) the other group will receive aerobic exercise program for PAD only.

Study Record Dates

• First Submitted: January 19, 2025
• First Posted: February 14, 2025
• Study Start: February 20, 2025
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)