drugset / Trial / NCT05368142
Nocardia Cell Wall Skeleton for the Treatment of Diabetic Foot Ulcer Wounds
Phase 4
Unknown
116 enrolled
The Affiliated Hospital of Xuzhou Medical University
Affiliated Hospital of Jiangnan University · collabAffiliated Hospital of Nantong University · collabGulou Hospital Affiliated to Medical College of Nanjing University · collabHuai'an First People's Hospital · collabSuzhou Municipal Hospital · collab
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2022-05-20
- Primary completion
- 2023-06-15
- Completion
- 2023-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fentanyl | Other / unclassified | — | Topical |
| Subject | Nocardia Rubra Cell Wall Skeleton | Unknown | — | Topical |