Nocardia Cell Wall Skeleton for the Treatment of Diabetic Foot Ulcer Wounds

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetic Foot Ulcer; Therapy, Directly Observed
• Intervention / Treatment: Drug: Nocardia rubra Cell Wall Skeleton; Drug: Silver ions dressing

• Study Type: Interventional
• Enrollment (Anticipated): 116
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Caiqi Shen; Phone Number: 86-15062128691; Email: shencaiqi@163.com
• Study Contact Backup: Name: Yixian Shan; Phone Number: 86-15062121367; Email: 834093222@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: N-CWS treatment group; Patients with N-CWS treatment	Drug: Nocardia rubra Cell Wall Skeleton; Nocardia rubra cell wall skeleton for external application; Other Names: Treatment group
Placebo Comparator: Control group（ treatment with Silver Ion-releasin); Patients with Silver Ion-releasin	Drug: Silver ions dressing; Silver ions dressing for external application; Other Names: Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound healing rate up to 30 days	The wound healing rate for 30 days treatment（physiological parameter）	30 days after first medicine application

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healing time	The time with complete closure of wound within 30 days treatment	From date medicine application until the complete closure of wound, assessed up to 30 days
Healing rate	The rate of complete closure of wound for 30 days treatment	30 days after first medicine application
Surgical intervention rate	The rate of Surgical intervention for 30 days treatment（physiological parameter）	From first medicine application to 30 days
Pathogenic bacteria positive rate	The rate of Pathogenic bacteria positive for 30 days treatment（physiological parameter）	30 days after first medicine application

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Xuzhou Medical University
• Collaborators: Affiliated Hospital of Jiangnan University; Suzhou Municipal Hospital; Affiliated Hospital of Nantong University; Huai'an First People's Hospital; Gulou Hospital Affiliated to Medical College of Nanjing University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 20, 2022
• Primary Completion (Anticipated): June 15, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: July 27, 2021
• First Submitted That Met QC Criteria: May 9, 2022
• First Posted (Actual): May 10, 2022

Study Record Updates

• Last Update Posted (Actual): May 10, 2022
• Last Update Submitted That Met QC Criteria: May 9, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Diabetic Foot Ulcer; Nocardia Rubra Cell Wall Skeleton
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer; Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; Cell Wall Skeleton
• Other Study ID Numbers: XYFY2021-KL151-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No