The Affiliated Hospital of Xuzhou Medical University
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.
Diabetic Foot Ulcer
Therapy, Directly Observed
Nocardia rubra Cell Wall Skeleton
Silver ions dressing
Phase 4
Study Type : | Interventional |
Estimated Enrollment : | 116 participants |
Masking: | Single |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | May 20, 2022 |
Estimated Primary Completion Date : | June 15, 2023 |
Estimated Study Completion Date : | December 31, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: N-CWS treatment group Patients with N-CWS treatment |
Drug: Nocardia rubra Cell Wall Skeleton |
Placebo Comparator: Control group( treatment with Silver Ion-releasin) Patients with Silver Ion-releasin |
Drug: Silver ions dressing |
Ages Eligible for Study: | 18 Years to 80 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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