Nano selenium and hybrid polymer incorporated nano hydrogel for Rapid diabetic wound healing activity
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
Diabetic foot ulcers are a common and serious complication of Type 2 Diabetes Mellitus and are associated with delayed wound healing increased risk of infection and higher rates of hospitalization and amputation Persistent oxidative stress chronic inflammation and impaired angiogenesis play a key role in poor wound healing in diabetic patients Conventional wound dressings often fail to provide sustained therapeutic benefits
This study aims to evaluate the safety and efficacy of a nano selenium and hybrid polymer incorporated nano hydrogel for rapid diabetic wound healing Selenium nanoparticles possess antioxidant anti inflammatory and antimicrobial properties which may reduce oxidative stress control infection and promote tissue regeneration The hybrid polymer nano hydrogel is designed to provide a moist wound environment controlled release of active components and enhanced biocompatibility
This randomized controlled clinical study will include patients with Wagner Grade I and II diabetic foot ulcers The primary outcome will be percentage reduction in wound area and time to complete wound closure Secondary outcomes will include infection status pain score and safety assessment
The study intends to determine whether the novel nano hydrogel formulation improves healing outcomes compared to standard wound care in diabetic patients
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Age between 18 and 75 years Confirmed diagnosis of Type 2 Diabetes Mellitus Presence of a chronic diabetic foot ulcer of duration greater than 4 weeks Wagner Grade I or II diabetic foot ulcers Ulcer size measuring 1 to 10 cm2 at baseline assessment HbA1c less than or equal to 12 percent indicating manageable glycemic status.
排除标准
- •Wagner Grade III to V ulcers including deep infection gangrene or osteomyelitis Non diabetic ulcers including venous arterial traumatic or malignant ulcers Severe peripheral arterial disease defined as Ankle Brachial Index less than 0.8 Active systemic infection or sepsis Known allergy to selenium or any hydrogel components Chronic kidney disease stage IV or V.
研究者
DR S NIMITHAP
SAVEETHA MEDICAL COLLEGE AND HOSPITAL