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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-01

Study Completion Date

2023-12-31

Brief Summary

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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

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Detailed Description

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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

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Diabetic Foot Ulcer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Treatment group

Treated with probiotics in soybean concentrate

probiotics in soybean concentrate

Intervention Type OTHER

treatment with topical probiotics on DFU

control group

Treated with placebo

probiotics in soybean concentrate

Intervention Type OTHER

treatment with topical probiotics on DFU

Interventions

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probiotics in soybean concentrate

treatment with topical probiotics on DFU

Intervention Type OTHER

Other Intervention Names

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Lactera

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No