Clinical Research Directory

Evaluating the Efficacy of Pulsating Electromagnetic Field Therapy by CRAD ULCER X-01 for Diabetic Foot Ulcers

Background: Diabetic foot ulcer (DFU) is a frequent complication of chronic, uncontrolled diabetes mellitus (DM). Treatment with antibiotics, daily dressing, wound debridement, and wound off-loading is often prescribed. However, many DFU patients still progress into severe outcomes, including non-healing of wounds, infections, necrosis, and osteomyelitis. Prior research has shown that the application of pulsating electromagnetic field (PEMF) could accelerate wound healing, including in those afflicted with DFUs. Therefore, this study aimed to evaluate the efficacy of a locally developed CRAD ULCER X-01 device that uses the principles of PEMF in promoting DFU healing. Methods: A total of 32 patients with chronic, non-healing DFUs will be recruited from the Orthopaedic Clinic of Hospital Angkatan Tentera Tuanku Mizan and divided into control (C) (n=8) and treatment (T) (n=24) groups. All patients will receive a standard daily dressing. The PEMF will be supplemented for 1 hour/day, 2 hours/day, and 3 hours/day for T1, T2, and T3 subgroups, respectively (n=8 per group); whereas the C group will be controlled for placebo effect (device in-place but switched off). The therapy duration will be until the wound is closed or for a maximum period of three months. All patients will undergo wound assessment, wound edge tissue histology by haematoxylin and eosin (H\&E) staining, and immunohistology (for vascular endothelial growth factor \[VEGF\] and fibroblast growth factor 2 \[FGF-2\] expression), as well as serum superoxide dismutase (SOD) and C-reactive protein (CRP) at preand post-treatment, along with glycated haemoglobin (HbA1c) measurement only at post-treatment to control for confounder (i.e., glucose control for the past three months). This study hypothesizes that PEMF therapy by CRAD ULCER X-01 device will accelerate DFU healing and improve tissue integrity, with minimal systemic effects assessed via oxidative stress and inflammatory markers. Conclusion: The results from this study will validate PEMF's effectiveness in promoting DFU healing and establish the potential use of locally developed CRAD ULCER X-01 devices as supplementary therapy to standard DFU care.

This Study is Conducted to Evaluate the 18-month Clinical Performance of Complete Bioactive Restorative System for Occlusal Restorations Between Diabetic and Non-diabetic Patients.

This study is conducted to evaluate the 18-month clinical performance of complete bioactive restorative system for occlusal restorations between diabetic and non-diabetic patients.

Central Sensitization in Painful and Painless Diabetic Peripheral Neuropathy

This research is structured as a cross-sectional observational study. The primary objective is to compare central sensitization across painful and painless phenotypes of diabetic peripheral neuropathy. The study will be conducted among individuals diagnosed with type 2 diabetes mellitus at the Department of Geriatrics, İnönü University Turgut Özal Medical Center. All assessments will be administered in accordance with a rigorously standardized protocol. Eligible participants will include individuals aged 18 to 80 years who have had a confirmed diagnosis of type 2 diabetes mellitus for at least one year, are capable of comprehending and following verbal instructions in Turkish required for the study procedures, and provide written informed consent. All statistical analyses will be performed using IBM SPSS Statistics (v.29, Armonk, NY, USA) and JASP (v.0.18, Amsterdam, Netherlands).

Evaluation of the Psychometric Properties of the Turkish Version of the Hypoglycaemia Self-Care Behaviour Scale

The aim of this study is to validate the validity and reliability of the Hypoglycaemia Self-Care Behaviour Scale, developed to assess hypoglycaemia self-care behaviours in patients with type 2 diabetes, through a prospective cross-sectional study.

Effect of Golden Rice-Piper Crocatum Cookies on Neuropathy Prevention in Diabetes

Diabetes mellitus is a chronic disease that can cause many complications, one of the most common being diabetic neuropathy. This condition occurs due to long-term high blood sugar levels that damage the nerves. Symptoms include tingling, burning, pain, and loss of sensation in the feet. If not prevented, neuropathy can progress to diabetic foot ulcers and even lead to amputation. This study aims to evaluate whether Golden Rice Cookies enriched with Red Betel Leaf (Piper crocatum) can help prevent diabetic neuropathy in patients with diabetes. Golden rice is a type of rice that contains beta-carotene (provitamin A) and high fiber, which help maintain stable blood sugar levels and reduce oxidative stress. Meanwhile, red betel leaf contains flavonoids, polyphenols, and alkaloids with antioxidant, anti-inflammatory, and hypoglycemic properties that may protect nerves from damage. Cookies were chosen as the intervention form because they are practical, easy to consume, and widely accepted by patients. In this study, patients will be divided into two groups: an intervention group receiving golden rice cookies with red betel leaf extract, and a control group receiving golden rice cookies without the extract. Changes in neuropathy symptoms will be assessed using the Neuropathy Symptom Score (NSS) before and after the intervention. The expected outcome of this research is to provide scientific evidence that the combination of golden rice and red betel leaf in the form of cookies can serve as an effective, safe, and acceptable functional food to help prevent diabetic neuropathy. This nutritional intervention may support comprehensive diabetes management and improve patients' quality of life.

Impact of Golden Rice-Piper Crocatum Cookies on Lipid Control in Diabetes Mellitus Patients

People with diabetes often experience abnormal blood fat levels, known as dyslipidemia, which increase the risk of heart disease and stroke. The aim of the study, researchers are exploring a natural and practical solution through a healthy snack in the form of cookies. These cookies are made from Golden Rice, which is rich in beta-carotene as a natural antioxidant, and Piper crocatum (red betel leaf) extract, which contains polyphenols and flavonoids that may help lower cholesterol, reduce inflammation, and protect blood vessels. In this study, patients with diabetes will consume the cookies for 28 days, and their blood fat levels will be measured before and after the intervention. The results will then be compared with those of a control group who receive the Golden rice cookies without piper crocatum extract. This research aims to show that Golden Rice with Piper crocatum extract cookies can reduce bad cholesterol and triglycerides, increase good cholesterol, and serve as a safe, affordable, and acceptable food option to support daily diabetes care. If successful, this approach may offer patients and families a simple way to help prevent complications and improve quality of life, alongside regular treatment and lifestyle changes.

Improving the Activation Level of Diabetic Individuals

This study was planned to determine the activation levels of diabetic individuals and to improve the activation level. The study, planned as a descriptive and experimental type, is an attempt to increase the activation level of diabetic individuals.