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
1 other identifier
interventional
116
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started May 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 27, 2021
CompletedFirst Posted
Study publicly available on registry
May 10, 2022
CompletedStudy Start
First participant enrolled
May 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedMay 10, 2022
January 1, 2022
1.1 years
July 27, 2021
May 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Wound healing rate up to 30 days
The wound healing rate for 30 days treatment（physiological parameter）
30 days after first medicine application
Secondary Outcomes (4)
Healing time
From date medicine application until the complete closure of wound, assessed up to 30 days
Healing rate
30 days after first medicine application
Surgical intervention rate
From first medicine application to 30 days
Pathogenic bacteria positive rate
30 days after first medicine application
Study Arms (2)
N-CWS treatment group
EXPERIMENTALPatients with N-CWS treatment
Control group（ treatment with Silver Ion-releasin)
PLACEBO COMPARATORPatients with Silver Ion-releasin
Interventions
Nocardia rubra cell wall skeleton for external application
Silver ions dressing for external application
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Affiliated Hospital of Xuzhou Medical Universitylead
- Gulou Hospital Affiliated to Medical College of Nanjing Universitycollaborator
- Suzhou Municipal Hospitalcollaborator
- Affiliated Hospital of Nantong Universitycollaborator
- Affiliated Hospital of Jiangnan Universitycollaborator
- Huai'an First People's Hospitalcollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2021
First Posted
May 10, 2022
Study Start
May 20, 2022
Primary Completion
June 15, 2023
Study Completion
December 31, 2023
Last Updated
May 10, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share