Assessment of the Clinical, Cellular and Molecular Effects of Royalactin-Royal Jelly on the Healing of Wagner Grad II Diabetic Foot Ulcers.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Ulcer measurement in square centimeters
研究概览
简要总结
The aim of this study is to evaluate the clinical, cellular, and molecular effects of Royalactin as an adjunct to standard treatment, compared to standard treatment alone, in the treatment of Wagner grade II diabetic foot ulcers by assessing wound size, cell behavior (Epithelialization, polymorphonuclear neutrophils, fibroblasts, angiogenesis, and collagen), and growth factor expression. This is a prospective, randomized, double-blind, double-blind, experimental, longitudinal, comparative, controlled clinical trial.
详细描述
Materials and methods
Ethical Considerations The study was conducted in compliance with Good Clinical Practice (GCP) guidelines. All procedures adhered to the ethical standards of the Research and Bioethics Committee of the XXXXXXXXXX. the Declaration of Helsinki, and the General Health Law. Protocols were strictly followed, data were handled with rigorous confidentiality, and informed consent was obtained from all participants.
Inclusion Criteria Adult patients with Diabetes Mellitus undergoing treatment for foot and ankle wounds were included. Eligibility criteria required wounds larger than 4 cm², with more than 80% granulation tissue, involving skin, fat, or ligaments without bone involvement, and non-infected (Wagner Grade II). Additional requirements included a duration of more than 2 months, an ankle-brachial index (ABI) greater than 0.5, the signing of the informed consent form, and the ability to attend dressing changes three times per week for 4 weeks.
Experimental Agents and Randomization The FEMSA Biotechnology Center laboratory produced 20 tubes (50 ml) containing gold nanoparticles and emulsifiers. Ten tubes were formulated with Royalactin at 0.2 g/L, while the other 10 served as the control without the peptide. The laboratory randomized, numbered, and paired the tubes, providing a list for paired application.
Treatment Protocol Standardized dressing changes were performed three times per week for 4 weeks at the Chronic Wound, Diabetic Foot, and Hyperbaric Medicine Center of XXXXX. Each wound was first irrigated with sterile water and dried with sterile gauze. The wound was then divided (or the division was remarked) using black ink on the skin, and a 0.5 cm strip of Hypafix (BSN medical GmbH, ESSITY) was applied. A circular label was placed on the perilesional skin to identify the tube number (bottom), patient ID (top-right), and dressing change number (top-left).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Confirmed diagnosis of Diabetes Mellitus according to the 2020 ADA guidelines.
- •Stage II ulcer according to the Wagner classification for Diabetic Foot (deep ulcer, penetrating ligaments and muscles, without bone involvement or abscess formation).
- •Ulcer located on any area of the foot or ankle.
- •Ulcer with 80% granulation tissue.
- •Ankle-brachial index greater than 0.5 (not considered severe or critical arterial disease).
- •Negative stylet test.
- •Ability to attend wound care and follow-up appointments three times a week for four weeks.
- •Signed informed consent form.
排除标准
- •- History of hypersensitivity reactions to dermatological products.
- •History of generalized dermatological pathology or pathology affecting the foot.
- •Diagnosis of autoimmune disease.
- •Local or systemic infection.
- •Hypersensitivity to any of the components of the experimental product.
研究组 & 干预措施
Diabetic foot ulcers treated with Royalactin
Standardized wound care is performed 3 times a week with the application of Royalactin.
干预措施: Royalactina (Drug)
Diabetic foot ulcers with placebo application
Standardized treatments are performed 3 times a week with placebo application.
干预措施: Placebo (Drug)
结局指标
主要结局
Ulcer measurement in square centimeters
时间窗: 4 weeks
A photograph is taken at the beginning and at 4 weeks and measured with a program in square centimeters.
次要结局
- The histological section of the ulcer margins at baseline and at 4 weeks is tabulated and compared(4 weeks)
研究者
José Luis Elizondo Hinojosa
DOCTOR
Universidad Autonoma de Nuevo Leon