Clinical trial NCT05368142: Nocardia Cell Wall Skeleton for the Treatment of Diabetic Foot Ulcer Wounds
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetic Foot Ulcer
Therapy, Directly Observed
Keywords: Diabetic Foot Ulcer
Nocardia Rubra Cell Wall Skeleton
Lead sponsor: The Affiliated Hospital of Xuzhou Medical University
Sponsor class: OTHER
Collaborators: name: Gulou Hospital Affiliated to Medical College of Nanjing University
name: Suzhou Municipal Hospital
name: Affiliated Hospital of Nantong University
name: Affiliated Hospital of Jiangnan University
name: Huai'an First People's Hospital
First posted: 2022-05-10
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Wound healing rate up to 30 days
timeFrame: 30 days after first medicine application
Secondary outcomes:
measure: Healing time
timeFrame: From date medicine application until the complete closure of wound, assessed up to 30 days
measure: Healing rate
timeFrame: 30 days after first medicine application
measure: Surgical intervention rate
timeFrame: From first medicine application to 30 days
measure: Pathogenic bacteria positive rate
timeFrame: 30 days after first medicine application
Other outcomes:
Locations:
Study officials:
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