Clinical trial NCT07008573: Prospective, Randomized, Multi-Center Comparative Study on Topical Probiotics in Diabetic Foot Ulcers
Official title: Prospective, Randomized, Multi-Center Comparative Study Evaluating the Efficacy of Topical Probiotics in Soyabean Concentrate in the Management of Diabetic Foot Ulcers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Foot Ulcer
Keywords: probiotics
soybean concentrate
Lead sponsor: Tzu Chi University
Sponsor class: OTHER
Collaborators: name: Hualien Tzu Chi General Hospital
name: Taichung Tzu Chi Hospital
First posted: 2025-06-06
Enrollment: 65
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: incidence of complete wound closure at 24weeks.
timeFrame: 24 weeks
Secondary outcomes:
measure: time to healing and incidence of ulcer recurrence at the site of the study ulcer during the follow-up phase
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Dalin
country: Taiwan
facility: Dalin Tzu Chi Hospital
state: Chaiyi
Study officials:
affiliation: Tzu Chi University
name: Honda Hsu, MBChB
role: PRINCIPAL_INVESTIGATOR
References: