An open-label, non-interventional, observational study of Human Placental extract Cream in patients with diabetic foot ulcers and bedsores across tertiary care centers.

Albert David Limited2 个研究点分布在 1 个国家目标入组 100 人开始时间: 2024年10月14日最近更新: 2025年10月3日

试验速览

阶段: 4 期
状态: 尚未招募
发起方
入组人数: 100
试验地点: 2
主要终点: Response to treatment is measured by percentage of patients with

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

In a pioneering observational study, 100 participants with diabetic foot ulcers or bedsores will be observed over 12 weeks at tertiary care centers. After informed consent, 60 subjects with diabetic foot ulcers and 40 with bedsores will undergo thorough physical and wound examinations, alongside laboratory tests. Wound characteristics, including size, type, redness, infection, inflammation, slough, vascular insufficiencies, and atrophy signs, will be meticulously recorded. Wound dimensions will be measured using translucent graph paper, and baseline photographs will be taken. Subjects will apply a topical Cream twice daily after cleaning wounds with povidone iodine. Healing will be visually assessed at baseline and study’s end, with photographs documenting progress. Participants, aged 40-70, must have wounds persisting for over two weeks, meet specific size criteria, and exhibit no signs of infection. The study aims to measure wound healing percentage, safety, tolerability, and healing time, with evaluations at weeks 4, 8, and 12. Treatment response will be gauged by wound size reduction, healthy tissue, absence of pus or necrosis, no bleeding during dressing, scar formation, and lack of skin discoloration or atrophy. Adverse events and other care aspects will also be monitored to ensure safety and efficacy.

研究设计

研究类型: Interventional
分配方式: Na
盲法: None

入排标准

年龄范围: 40.00 Year(s) 至 70.00 Year(s)（—）
性别: All

入选标准

•Subjects aged between 40-70 years of any sex.
•Subjects clinically diagnosed with diabetic foot ulcers and bedsores with wounds of more than two weeks duration.
•Subjects with diabetic foot ulcers having an area not more than 5cm squire of area of ulcer and of more than six weeks duration
•Diabetic foot ulcers ulcer should be free of necrotic debris, foreign bodies, sinus tracts, tunnelling, and undermining.
•Subjects with bedsores having an area not more than 3 cm squire of area of ulcer.
•The diabetic foot ulcers had to be clinically noninfected (Infection will be diagnosed based on clinical signs and symptoms)
•Subjects with bedsores with wounds of more than 1 to 2 weeks duration.
•Subjects willing for informed consent.
•Subjects willing for regular follow up.
•Women of childbearing age should not be pregnant or lactating.

排除标准

•Pregnancy and lactating mothers
•Pediatric subjects (less than 18 years of age).
•Subjects with diabetic foot ulcers having an area more than 5Ã—5 cm of area of ulcer, full thickness and exposure of bone, muscle, ligaments, or tendons.
•Subjects with chronic CVD (Coronary/Cerebro Vascular Disease), CKD.
•stages III and IV.
•Ulcers with malignant aetiologies.
•Subjects who require hospitalization.
•Subject with history of active ulcer, active arthropathy or foot infection.
•Subjects not willing to participate in the study.