NCT06713720 Remote Ischemic Conditioning for Non-Proliferative Diabetic Retinopathy
| NCT ID | NCT06713720 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xuxiang Zhang, MD |
| Condition | Diabetic Retinopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 68 participants |
| Start Date | 2025-04-20 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 68 participants in total. It began in 2025-04-20 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to evaluate whether remote ischemic conditioning (RIC) is a safe and effective treatment for non-proliferative diabetic retinopathy (NPDR) in adults aged 40-80 years with type 2 diabetes. The study aims to address the limitations of current treatments for NPDR by using RIC, a technique involving repeated cycles of ischemia and hypoxia stimulation to activate protective mechanisms against retinal damage. The main questions it aims to answer are: Does RIC improve the Diabetic Retinopathy Severity Score (DRSS) after one year of treatment? Does RIC reduce the incidence of vision-threatening proliferative diabetic retinopathy (PDR)? What are the changes in retinal neurovascular unit parameters, visual acuity, and retinal oxygen saturation after RIC treatment? Participants will: Undergo RIC therapy using a specialized device on both upper limbs (or a placebo intervention for the control group) for 1 year. Complete 5 cycles of RIC or placebo treatment twice daily, 5 days per week. Receive routine care for diabetic retinopathy as per clinical guidelines. Key outcome measures: Primary outcome: Change in DRSS from baseline after one year. Secondary outcomes: Incidence of PDR, changes in visual acuity, retinal neurovascular unit measures, retinal oxygen saturation, and serum biomarkers (e.g., VEGF, CRP, IL-6). This randomized, double-blind, placebo-controlled trial aims to recruit 68 participants to ensure 60 complete the study, accounting for a 13% dropout rate. The findings are expected to provide insights into RIC as a novel intervention for NPDR, reducing blindness risk and supporting future large-scale trials.
Eligibility Criteria
Inclusion Criteria: * Age between 40 and 80 years. * Diagnosed with Type 2 diabetes mellitus. * Diagnosed with mild to moderate non-proliferative diabetic retinopathy (NPDR) with a DR Severity Score (DRSS) grade of 20-47D. * Capable of performing daily activities independently. * Willing and able to provide informed consent. Exclusion Criteria: * Presence of diabetic macular edema (macular thickness \> 250 μm). * Significant eye diseases affecting evaluation, such as high myopia, severe cataract, corneal leucoma, glaucoma, retinal detachment, retinal vein occlusion, congenital eye diseases, ocular tumors, or severe infection. * History of ocular laser or intraocular surgery. * Poor imaging quality due to refractive media opacity. * Contraindication to fluorescein fundus angiography. * Unstable blood glucose (HbA1c ≥ 8.0%) despite oral antidiabetic drugs. * Severe diabetes complications within the past 6 months. * Severe, sustained hypertension (systolic ≥ 180 mmHg or diastolic ≥ 110 mmHg). * Body mass index (BMI) ≥ 28 kg/m². * Hepatic or renal insufficiency: Alanine aminotransferase or aspartate aminotransferase \> 2 times the upper limit of normal. Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73m². Urine albumin/creatinine ratio ≥ 30 mg/g. * Myocardial infarction within the past 6 months. * Neurological diseases such as Alzheimer's, Parkinson's, cerebrovascular disease, intracranial tumor, cerebrovascular malformation, or aneurysm. * Contraindications to RIC, including one-sided subclavian artery stenosis, upper limb injuries or vascular diseases, or limb deformities. * Severe systemic diseases, such as malignant tumors with a life expectancy of less than 24 months. * Known pregnancy or breastfeeding. * Participation in other experimental clinical studies. * Any other conditions deemed unsuitable by the investigator.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06713720 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 80 Years, studying Diabetic Retinopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06713720 currently recruiting?
Yes, NCT06713720 is actively recruiting participants. Contact the research team at shanhe829@163.com for enrollment information.
Where is the NCT06713720 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China.
Who is sponsoring the NCT06713720 clinical trial?
NCT06713720 is sponsored by Xuxiang Zhang, MD. The trial plans to enroll 68 participants.