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

NCT05368142 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2022-05-10

No results posted yet for this study

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.

Conditions

  • Diabetic Foot Ulcer
  • Therapy, Directly Observed

Interventions

DRUG

Nocardia rubra Cell Wall Skeleton

Nocardia rubra cell wall skeleton for external application

DRUG

Silver ions dressing

Silver ions dressing for external application

Sponsors & Collaborators

  • Gulou Hospital Affiliated to Medical College of Nanjing University

    collaborator UNKNOWN

  • Suzhou Municipal Hospital

    collaborator OTHER

  • Affiliated Hospital of Nantong University

    collaborator OTHER

  • Affiliated Hospital of Jiangnan University

    collaborator OTHER

  • Huai'an First People's Hospital

    collaborator OTHER

  • The Affiliated Hospital of Xuzhou Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-20
Primary Completion
2023-06-15
Completion
2023-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05368142 on ClinicalTrials.gov