Diabetic Foot UlcerNCT07008573
Prospective, Randomized, Multi-Center Comparative Study on Topical Probiotics in Diabetic Foot Ulcers
An observational study of Diabetic Foot Ulcer, run by Tzu Chi University at 1 site in Taiwan.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- probiotics in soybean concentrate
- How many people
- 65 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Feb 2022to 31 Dec 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with diabetic foot ulcers without bone or tendon exposure with ulcer size between 1 cm² and < 25 cm²
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Randomized, Multi-Center Comparative Study Evaluating the Efficacy of Topical Probiotics in Soyabean Concentrate in the Management of Diabetic Foot Ulcers
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
Read the 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
- Being tested
- probiotics in soybean concentrate
- Keywords
- probiotics, soybean concentrate
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probiotics in soybean concentrateOther
Also called Lactera
treatment with topical probiotics on DFU
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Treated with probiotics in soybean concentrate Receives: Other: probiotics in soybean concentrate | |
| control group | Treated with placebo Receives: Other: probiotics in soybean concentrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of complete wound closure at 24weeks.
Measured: 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
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start1 Feb 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Tzu Chi University
- Sponsor type
- University, hospital or other
- Collaborators
- Hualien Tzu Chi General Hospital, Taichung Tzu Chi Hospital
- Responsible party
- Principal investigator, Honda Hsu, Tzu Chi University
- Investigators
- Honda Hsu, MBChB, Principal investigator, Tzu Chi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008573
- Sponsor's protocol ID
- A11002001
- Status last verified
- May 2025
- First submitted
- 29 May 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Multi-Center Comparative Study Evaluating the Efficacy of Topical Probiotics in Soyabean Concentrate in the Management of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT07008573
- Acronym / sponsor ID
- A11002001
- Conditions
- Diabetic Foot Ulcer
- Keywords
- probiotics, soybean concentrate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Tzu Chi UniversityUniversity, hospital or other
- Collaborators
- Hualien Tzu Chi General Hospital, Taichung Tzu Chi Hospital
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | – | Other: probiotics in soybean concentrateTreated with probiotics in soybean concentrate |
| control group | – | Other: probiotics in soybean concentrateTreated with placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with diabetic foot ulcers without bone or tendon exposure with ulcer size between 1 cm² and < 25 cm²
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| probiotics in soybean concentrateAlso: Lacteratreatment with topical probiotics on DFU | Other | Treatment group, control group |
Primary outcome
incidence of complete wound closure at 24weeks.
Time frame: 24 weeks
1 secondary outcome
time to healing and incidence of ulcer recurrence at the site of the study ulcer during the follow-up phase
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Honda Hsu, MBChB principal investigator
Tzu Chi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot Ulcer, run by Tzu Chi University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of complete wound closure at 24weeks. (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.