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

Sponsor

The Affiliated Hospital of Xuzhou Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05368142

Collaborator

Gulou Hospital Affiliated to Medical College of Nanjing University (Other), Suzhou Municipal Hospital (Other), Affiliated Hospital of Nantong University (Other), Affiliated Hospital of Jiangnan University (Other), Huai'an First People's Hospital (Other)

116

Enrollment

Arms

19.4

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Foot Ulcer Therapy, Directly Observed	Drug: Nocardia rubra Cell Wall Skeleton Drug: Silver ions dressing	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

116 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

May 20, 2022

Anticipated Primary Completion Date :

Jun 15, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Wound healing rate up to 30 days [30 days after first medicine application]
The wound healing rate for 30 days treatment（physiological parameter）

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.