Nocardia Cell Wall Skeleton for the Treatment of Diabetic Foot Ulcer Wounds
NCT ID: NCT05368142
Last Updated: 2022-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
116 participants
INTERVENTIONAL
2022-05-20
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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N-CWS treatment group
Patients with N-CWS treatment
Nocardia rubra Cell Wall Skeleton
Nocardia rubra cell wall skeleton for external application
Control group（ treatment with Silver Ion-releasin)
Patients with Silver Ion-releasin
Silver ions dressing
Silver ions dressing for external application
Interventions
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Nocardia rubra Cell Wall Skeleton
Nocardia rubra cell wall skeleton for external application
Silver ions dressing
Silver ions dressing for external application
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Gulou Hospital Affiliated to Medical College of Nanjing University
UNKNOWN
Suzhou Municipal Hospital
OTHER
Affiliated Hospital of Nantong University
OTHER
Affiliated Hospital of Jiangnan University
OTHER
Huai'an First People's Hospital
OTHER
The Affiliated Hospital of Xuzhou Medical University
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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XYFY2021-KL151-01
Identifier Type: -
Identifier Source: org_study_id
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