Nocardia Cell Wall Skeleton for the Treatment of Diabetic Foot Ulcer Wounds
Primary Purpose
Diabetic Foot Ulcer, Therapy, Directly Observed
Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Nocardia rubra Cell Wall Skeleton
Silver ions dressing
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Diabetic Foot Ulcer, Nocardia Rubra Cell Wall Skeleton
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
N-CWS treatment group
Control group( treatment with Silver Ion-releasin)
Arm Description
Patients with N-CWS treatment
Patients with Silver Ion-releasin
Outcomes
Primary Outcome Measures
Wound healing rate up to 30 days
The wound healing rate for 30 days treatment(physiological parameter)
Secondary Outcome Measures
Healing time
The time with complete closure of wound within 30 days treatment
Healing rate
The rate of complete closure of wound for 30 days treatment
Surgical intervention rate
The rate of Surgical intervention for 30 days treatment(physiological parameter)
Pathogenic bacteria positive rate
The rate of Pathogenic bacteria positive for 30 days treatment(physiological parameter)
Full Information
NCT ID
NCT05368142
First Posted
July 27, 2021
Last Updated
May 9, 2022
Sponsor
The Affiliated Hospital of Xuzhou Medical University
Collaborators
Gulou Hospital Affiliated to Medical College of Nanjing University, Suzhou Municipal Hospital, Affiliated Hospital of Nantong University, Affiliated Hospital of Jiangnan University, Huai'an First People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05368142
Brief Title
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
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 20, 2022 (Anticipated)
Primary Completion Date
June 15, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Affiliated Hospital of Xuzhou Medical University
Collaborators
Gulou Hospital Affiliated to Medical College of Nanjing University, Suzhou Municipal Hospital, Affiliated Hospital of Nantong University, Affiliated Hospital of Jiangnan University, Huai'an First People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer, Therapy, Directly Observed
Keywords
Diabetic Foot Ulcer, Nocardia Rubra Cell Wall Skeleton
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
116 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
N-CWS treatment group
Arm Type
Experimental
Arm Description
Patients with N-CWS treatment
Arm Title
Control group( treatment with Silver Ion-releasin)
Arm Type
Placebo Comparator
Arm Description
Patients with Silver Ion-releasin
Intervention Type
Drug
Intervention Name(s)
Nocardia rubra Cell Wall Skeleton
Other Intervention Name(s)
Treatment group
Intervention Description
Nocardia rubra cell wall skeleton for external application
Intervention Type
Drug
Intervention Name(s)
Silver ions dressing
Other Intervention Name(s)
Control group
Intervention Description
Silver ions dressing for external application
Primary Outcome Measure Information:
Title
Wound healing rate up to 30 days
Description
The wound healing rate for 30 days treatment(physiological parameter)
Time Frame
30 days after first medicine application
Secondary Outcome Measure Information:
Title
Healing time
Description
The time with complete closure of wound within 30 days treatment
Time Frame
From date medicine application until the complete closure of wound, assessed up to 30 days
Title
Healing rate
Description
The rate of complete closure of wound for 30 days treatment
Time Frame
30 days after first medicine application
Title
Surgical intervention rate
Description
The rate of Surgical intervention for 30 days treatment(physiological parameter)
Time Frame
From first medicine application to 30 days
Title
Pathogenic bacteria positive rate
Description
The rate of Pathogenic bacteria positive for 30 days treatment(physiological parameter)
Time Frame
30 days after first medicine application
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caiqi Shen
Phone
86-15062128691
Email
shencaiqi@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yixian Shan
Phone
86-15062121367
Email
834093222@qq.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Nocardia Cell Wall Skeleton for the Treatment of Diabetic Foot Ulcer Wounds
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