NCT05368142

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: The Affiliated Hospital of Xuzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Nocardia rubra Cell Wall Skeleton	Nocardia rubra cell wall skeleton for external application
DRUG	Silver ions dressing	Silver ions dressing for external application

Timeline

• Start date: 2022-05-20
• Primary completion: 2023-06-15
• Completion: 2023-12-31
• First posted: 2022-05-10
• Last updated: 2022-05-10