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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
The Affiliated Hospital of Xuzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

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

    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
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    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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