NCT05368142Unknown4 期
The Clinical Efficacy and Safety of Topical Nocardia Cell Wall Skeleton in the Treatment of Diabetic Foot Ulcer Wounds- A Prospective, Randomized, Controlled, Multicentre Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 116
- 主要终点
- Wound healing rate up to 30 days
研究概览
简要总结
This study was to investigate the efficacy and safety of Nocardia rubra Cell Wall Skeleton (NCWS) in the treatment of diabetic foot ulcer wounds. The study was a prospective, randomized, controlled, multicentre study . The subjects were randomly divided into two groups: NCWS group and control group（silver ions dressing）, with a total of 116 cases and 58 cases in each group. Patients in the NCWS group received nocardia rubra cell wall skeleton for external use, in parallel with silver ions dressing treatment. The efficacy and side effects were observed, with a primary endpoint of 30-days wound healing rate.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ages 18 to 80 years old (including 18 and 80 years of age), gender not limited;
- •in patients with type 2 diabetic foot, in 1999 the WHO diagnostic criteria, diabetic foot screening period or three months before randomization glycated hemoglobin (HbA1C) was detected in 10% or less;
- •the target body ankle brachial index of at least 0.8, without intermittent claudication walkers;
- •the target ulcer must have the following characteristics: A) according to the Wagner ulcer classification system for level 1 or level 2 B) ulcer is located in the foot, ankle and shin before; C) wound area of 2-5 cm2; D) has existed at least 4 weeks before randomization; E) if you have multiple wounds, select into the set standard and area is one of the biggest intervention and evaluation of the wound.The rest of the wound conventional treatment is not included in the study;If there are two or more wounds are the biggest, choose the worst into classification research;If there are two or more wound area and the classification, choice wound area are the longest study; F) without visible pus and necrotic material;
- •voluntary to participate in this clinical study, cooperate a doctor to conduct research, and sign the informed consent.
排除标准
- •with clear surgical indications, such as vascular occlusion, bone exposed, abscess, osteomyelitis, etc;
- •into the group of the first 3 months of vascular reconstruction or angioplasty;
- •impaired liver function (ALT and AST 3 times more than normal limit, AST, aspartate amino transferase;ALT: alanine aminotransferase);
- •serum creatinine greater than 2 times the upper limit of normal value;
- •serum albumin < 2.0 g/dL;
- •is undergoing immunosuppressive medication;
- •Various malignant tumor patients ;
- •of pregnant women, nursing mothers, or in the near future with family planning; ● with nerve, mental disorders and can't cooperation or unwilling to partners, has a history of alcoholism, drug abuse, and failed to quit;
- •into the group of the first 3 months participated in other clinical subjects; Cartesian bacteria cell wall
- •to use red, skeleton or silver products are taboo, allergies or known allergies;
- •researchers believe that patients should not participate in this study to other situations.
研究组 & 干预措施
N-CWS treatment group
Experimental
Patients with N-CWS treatment
干预措施: Nocardia rubra Cell Wall Skeleton (Drug)
Control group（ treatment with Silver Ion-releasin)
Placebo Comparator
Patients with Silver Ion-releasin
干预措施: Silver ions dressing (Drug)
结局指标
主要结局
Wound healing rate up to 30 days
时间窗: 30 days after first medicine application
The wound healing rate for 30 days treatment（physiological parameter）
次要结局
- Healing time(From date medicine application until the complete closure of wound, assessed up to 30 days)
- Surgical intervention rate(From first medicine application to 30 days)
- Pathogenic bacteria positive rate(30 days after first medicine application)
- Healing rate(30 days after first medicine application)
研究者
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