Clinical Research Directory

Safety and Effect of Peripheral Nerve Decompression Combined With Peripheral Nerve Stimulation for Painful Diabetic Peripheral Neuropathy

Diabetic peripheral neuropathy (DPN) is one of the most common chronic complications of diabetes mellitus and a major cause of lower extremity pain, numbness, sensory loss, balance disturbance, diabetic foot ulcer and amputation. Painful diabetic peripheral neuropathy (PDPN) is characterized by burning, stabbing or electric-shock pain, accompanied by numbness, paresthesia and sleep disturbance. Current treatments including glycemic control, neurotrophic agents and analgesics such as pregabalin and duloxetine only provide limited pain relief with adverse effects, and cannot effectively improve numbness or restore nerve function. Secondary peripheral nerve entrapment induced by nerve edema contributes to the progression of DPN. Peripheral nerve decompression can relieve nerve compression, improve nerve blood supply and alleviate pain and numbness, and reduce the risk of foot ulcer and amputation. However, numbness may not be fully relieved in some patients after decompression alone, due to chronic nerve injury. Peripheral nerve stimulation (PNS), a targeted neuromodulation technique, can modulate abnormal nerve discharge and reduce peripheral sensitization, which may further improve pain and sensory abnormalities. To date, there are limited studies evaluating combined peripheral nerve decompression plus PNS for PDPN. This study aims to evaluate the safety and efficacy of combined peripheral nerve decompression and peripheral nerve stimulation compared with peripheral nerve decompression alone in patients with painful diabetic peripheral neuropathy. The primary objective is to explore whether the combined therapy yields superior pain relief and recovery of nerve function, to provide new clinical evidence for individualized treatment of PDPN.

Effects of a Specialized Diabetes and Heart Clinic and Detection of Unrecognized Heart Failure in People With Type 2 Diabetes and Cardiovascular Disease

The goal of this clinical trial is to investigate the effects of a specialized Cardio-Metabolic Clinic (CMC) in people with type 2 diabetes and established cardiovascular disease. The CMC provides integrated and individualized diabetes and cardiovascular care aimed at optimizing medication, lifestyle, and management of related health conditions. Treatment recommendations are supported by a decision-support algorithm combining individual patient information with current clinical guidelines. Echo-CT-ProtecT-2D comprises two parallel studies conducted within the same randomized study population: Study 1 - EchoProtecT-2D focuses on cardiac function and heart failure phenotyping. The main questions are: * Can treatment in the CMC improve heart function at rest and during physical activity compared with usual care? * Can treatment in the CMC reduce systemic inflammation and improve physical function, symptoms, and quality of life? * How common is previously unrecognized heart failure, particularly heart failure with preserved ejection fraction (HFpEF), in this high-risk population? Study 2 - CT-ProtecT-2D focuses on coronary inflammation and atherosclerosis. The main questions are: * Can treatment in the CMC reduce inflammation around the coronary arteries compared with usual care? * Can treatment in the CMC reduce the burden of coronary atherosclerosis compared with usual care? * Can treatment in the CMC lead to favorable changes in the composition and high-risk features of coronary atherosclerotic plaques compared with usual care? Participants will be randomly assigned to either treatment in the CMC or usual care provided by their regular healthcare providers. Participants will: * Have an ultrasound examination of the heart (echocardiography) at rest and during physical activity at baseline and after 12 months * Have a CT scan of the coronary arteries at baseline and after 12 months * Provide blood and urine samples * Complete questionnaires about symptoms and quality of life * Complete a six-minute walk test to assess physical function * If assigned to the CMC, attend additional clinic visits as needed to optimize treatment

Effect of Resisted Blood Flow Restriction

The goal of this clinical trial is to investigate the effect of adding resisted blood flow restriction (BFR) training to a standard exercise program in adults aged 50-60 with Type 2 Diabetes Mellitus (T2DM). The main questions it aims to answer are: Does adding BFR training significantly increase muscle strength compared to standard exercise alone? Does the BFR intervention lead to measurable improvements in balance and physical function? Researchers will compare a group performing standard therapeutic exercise combined with BFR to a control group performing the same exercise program without BFR to see if the BFR group achieves superior gains in strength and functional independence. Participants will: Complete a 12-week supervised exercise program in an outpatient setting. Wear compression cuffs on their limbs during low-intensity resistance exercises (for the BFR group). Undergo assessments for muscle strength (via handheld dynamometry), balance, and functional mobility before and after the intervention.

Effects of Leg Ergometer Versus Arm Ergometer on Blood Glucose, Exercise Tolerance, Weight, and Psychological Stress Among Gestational Diabetic Patients

The current study is a single-blind, parallel-group randomized controlled trial involving 108 participants with diabetes during pregnancy. The trial will compare leg ergometer with arm ergometer. Interventions will be delivered three times per week for eight weeks. The primary outcomes are glucose, exercise tolerance, weight, and psychological stress. Assessments will be conducted at baseline and after eight weeks. The trial will be carried out at Jinnah hospital, Services hospital, Sir Ganga Ram Hospital, Lahore. The hypothesis is that the leg ergometer including aerobic exercise will result in greater reduction in glucose and exercise tolerance, weight and stress management than arm ergometer.

Evaluation of Perioperative Myocardial Injury in Patients Undergoing Below-Knee Lower Extremity Surgery

The aim of this observational study was to detect myocardial damage by monitoring high-sensitive troponin I levels in patients undergoing below-knee extremity surgery with peripheral nerve block. The primary question it aims to answer is: How effective are peroperative high-sensitive troponin I levels in predicting myocardial damage? High-sensitive troponin I levels will be monitored intraoperatively and at 24 and 48 hours postoperatively.