NCT07008573

Prospective, Randomized, Multi-Center Comparative Study on Topical Probiotics in Diabetic Foot Ulcers

Prospective, Randomized, Multi-Center Comparative Study Evaluating the Efficacy of Topical Probiotics in Soyabean Concentrate in the Management of Diabetic Foot Ulcers

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 65 (actual)
• Sponsor: Tzu Chi University · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Looking at the efficacy of using Probiotics in Soyabean Concentrate in the management of diabetic lower extremity ulcers when administered by a wider variety of clinicians at multiple locations with a more heterogeneous patient

Detailed description

Diabetic foot ulcers and pressure injury wounds are still a very common problem. According to International Diabetic Federation (IDF) around 12-15% of the general diabetic patient with develops a diabetic foot ulcer. These ulcers if not properly treated and managed can lead to major limb amputation. The 5-year survival rate according to our own previous study is around 67%. The management of the diabetic foot ulcer is at present being met using advanced wound care and surgical debridement and reconstruction. Probiotics has recently being discussed as an effective form of management for these chronic wounds. Probiotics exert their positive effects through multiple mechanisms including: (a) competition with pathogenic bacteria for nutrients and binding sites on the host cell; (b) inactivation of toxins and metabolites, (c) production of antimicrobial substances that inhibit the growth of pathogenic microorganisms, and (d) stimulation/modulation of host immune response. Probiotic-host interactions involving epithelial cells (EC), dendritic cells (DC), and regulatory T lymphocytes have also been well studied particularly in the GI tract. This study looks at the efficacy of using Probiotics in Soyabean Concentrate in the management of diabetic lower extremity ulcers when administered by a wider variety of clinicians at multiple locations with a more heterogeneous patient

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
OTHER	probiotics in soybean concentrate	treatment with topical probiotics on DFU

Timeline

• Start date: 2022-02-01
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2025-06-06
• Last updated: 2025-06-06

Locations

1 site across 1 country: Taiwan