NCT06827171CompletedPhase 2
Impact of LLL and Aerobic Exercise on Peripheral Arterial Outcomes in Patients With Type 2 Diabetes
Impact of Low-level Laser and Aerobic Exercise on Peripheral Arterial Outcomes in Patients With Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 19 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 19 Jan 2025
- Start date
- 20 Feb 2025
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- Nouran Hesham Slama Younis
- Diseases
- Type 2 diabetes
- NCT number
- NCT06827171
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 40
- From 20 Feb 2025 to the primary completion date, 30 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- 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
Who the study is looking for
- 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)
Age in the registry: 55 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cairo University Coordinator of this site? Confirm its status | Cairo | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.