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
Sponsor study identifier
interventional
116
0 countries
N/A
Study Start
May 20, 2022
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Primary Completion
June 15, 2023
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Study Completion
December 31, 2023
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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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2023
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 27, 2021
Actual (reported)May 10, 2022
Actual (reported)May 20, 2022
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June 15, 2023
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December 31, 2023
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Wound healing rate up to 30 days
The wound healing rate for 30 days treatment（physiological parameter）
30 days after first medicine application
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
Patients with N-CWS treatment
Patients with Silver Ion-releasin
Nocardia rubra cell wall skeleton for external application
Silver ions dressing for external application
First Submitted
July 27, 2021
First Posted
May 10, 2022
Study Start
May 20, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 15, 2023
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Study Completion
December 31, 2023
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Last Updated
May 10, 2022
Record last verified: 2022-01
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Source: ClinicalTrials.gov.
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