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

NCT07008573 | Completed DMC

• 1 other identifier: A11002001
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Diabetic Foot Ulcer

Keywords

probiotics; soybean concentrate

Outcome Measures

Primary Outcomes (1)

• incidence of complete wound closure at 24weeks.

  24 weeks

Secondary Outcomes (1)

• time to healing and incidence of ulcer recurrence at the site of the study ulcer during the follow-up phase

  24 weeks

Study Arms (2)

Treatment group

Treated with probiotics in soybean concentrate

Other: probiotics in soybean concentrate

control group

Treated with placebo

Other: probiotics in soybean concentrate

Interventions

probiotics in soybean concentrate OTHER

treatment with topical probiotics on DFU

Also known as: Lactera

Treatment group; control group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with diabetic foot ulcers without bone or tendon exposure with ulcer size between 1 cm² and \< 25 cm²

You may qualify if:

• Age 20 or older Type 1 or Type 2 diabetes Able and willing to provide consent and agrees to comply with study procedures and follow-up evaluations Ulcer size 1cm2 and \< 25cm2 Ulcer duration of 4 weeks, unresponsive to standard wound care Serum creatinine \<3.0 mg/dL HBA1C \<12% No clinical peripheral arterial occlusive disease. Able to carry out the wound care as described in the study

You may not qualify if:

• Current participation in another clinical trial Ulcer with exposure of tendon or bone Severely infected wound Currently under radio or chemotherapy Known or suspected malignancy of current ulcer Use of biomedical/topical growth factor within previous 30 days Pregnant or breast feeding Taking medications considered to be immune system modulators Allergy to known sensitivity to Probiotics of Soyabean. Inability to carry out wound care as described in the study. Inability to sign an informed consent form

Sponsors & Collaborators

• Tzu Chi University: lead
• Hualien Tzu Chi General Hospital: collaborator
• Taichung Tzu Chi Hospital: collaborator

Study Sites (1)

Dalin Tzu Chi Hospital

Dalin, Chaiyi, Taiwan

Location

MeSH Terms

Conditions

Diabetic Foot

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Honda Hsu, MBChB

  Tzu Chi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 6, 2025
• Study Start: February 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 6, 2025

Record last verified: 2025-05

Locations

TW (1)