Diabetic Foot UlcerPhase 1NCT05145140
A Clinical Intervention Study of Tangningtongluo on Diabetic Foot Ulcer
A Phase 1 study testing Standardized Western Medicine Treatment, Tangningtongluo tablet and cream and Tangningtongluo tablet in people with Diabetic Foot Ulcer, run by Affiliated Hospital of Nantong University at 1 site in China.
Trial summary
Purpose and significance:With the increasing incidence of Diabetes mellitus (DM), the incidence rate of Diabetic Foot (DF) is raised. DF is a foot infection, ulceration and / or deep tissue destruction caused by nerve abnormalities and varying degrees of vascular lesions in DM patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Standardized Western Medicine Treatment, Tangningtongluo tablet and cream and Tangningtongluo tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2022to 31 Mar 2023
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Type 2 diabetes mellitus
- Clinical diagnosis of Diabetic Foot Ulcer
Who cannot join
- Type 1 diabetes mellitus(T1DM), special type of diabetes, gestational diabetes mellitus, drug-induced hyperglycemia
- TNTL allergy
- Chronic kidney failure（eGFR≤30ml/min/1.73cm2）, severe liver function damage (transaminase ≥ 3 times the normal value), acute or chronic pancreatitis, autoimmune disease, malignant tumors
- Recent acute complications of type 2 diabetes mellitus（ketoacidosis, hyperosmolar nonketotic diabetic coma, lactic acidosis etc.）or other emergency situations
- History of using glucocorticoids and immunosuppressants
- Mental illness and cognitive dysfunction or poor compliance, unable to take medication as required
- Malignant ulcer
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Gu Yunjuan
Nantong, Jiangsu, 226001
Gu Yunjuan, M.D/Ph.D, +8615851207860, desette@ntu.edu.cn
About this study
Purpose and significance:With the increasing incidence of Diabetes mellitus (DM), the incidence rate of Diabetic Foot (DF) is raised. DF is a foot infection, ulceration and / or deep tissue destruction caused by nerve abnormalities and varying degrees of vascular lesions in DM patients. The high incidence, disability and mortality rate of DF make it urgent to explore new ways to improve the cure rate, reduce the burden and elevate the quality of life. Previous studies have confirmed that traditional Miao ethic medicine Tangningtongluo(TNTL) can improve the remission rate of diabetes mellitus and diabetic foot disease, but the clinical research evidence is not sufficient. This study aims to provide effective clinical evidence for the treatment of diabetic foot patients with TNTL by observing growth rate of wound, prognosis and outcome.
Methods: From September 2021 to March 2023, a total of 80 diabetic foot ulcer patients admitted to Department of Endocrinology and Metabolism at the Affiliated Hospital of Nantong University were recruited. Participants are randomized in a ratio of 1: 1: 1:1 into four treatment groups of 20 participants: (i) standardized western medicine treatment group, (ii) standardized western medicine treatment+TNTL tablet+TNTL cream group , (iii) standardized western medicine treatment+TNTL tablet group, and (iiii) standardized western medicine treatment+TNTL cream group. Treatment with TNTL tablets: the oral administration of TNTL tablets, 4 tablets each time, 3 times a day. Treatment with TNTL cream: topical application of sterile TNTL cream on the wound surface, the dressing is continuously changed according to the wound healing. Anthropometric parameters, serum biochemical index, glycosylated hemoglobin, urinary microalbumin/creatinine ratio, islet-specific autoantibodies(ISAs), fat mass, and islet β-cell function were measured. The healing stage of the wound surface and the growth degree of granulation tissue were graded, and the time required for wound repairing to each healing stage was observed.
Type of study: randomized controlled, prospective,intervention study.
Read the detailed description
From September 2021 to March 2023, a total of 80 diabetic foot ulcer patients admitted to Department of Endocrinology and Metabolism at the Affiliated Hospital of Nantong University were recruited. Participants are randomized in a ratio of 1: 1: 1:1 into four treatment groups of 20 participants: (i) standardized western medicine treatment group, (ii) standardized western medicine treatment+TNTL tablet+TNTL cream group , (iii) standardized western medicine treatment+TNTL tablet group, and (iiii) standardized western medicine treatment+TNTL cream group. Treatment with TNTL tablets: the oral administration of TNTL tablets, 4 tablets each time, 3 times a day. Treatment with TNTL cream: topical application of sterile TNTL cream on the wound surface, the dressing is continuously changed according to the wound healing. Anthropometric parameters, serum biochemical index, glycosylated hemoglobin, urinary microalbumin/creatinine ratio, islet-specific autoantibodies(ISAs), fat mass, and islet β-cell function were measured. The healing stage of the wound surface and the growth degree of granulation tissue were graded, and the time required for wound repairing to each healing stage was observed.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Standardized Western Medicine Treatment, Tangningtongluo tablet and cream, Tangningtongluo tablet, Tangningtongluo cream
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Western Medicine TreatmentDrug
Also called Classic Diabetic Foot Ulcer treatment
Standardized Western Medicine Treatment includes hypoglycemic, debridement and anti infection treatments.
Tangningtongluo tablet and creamDrug
Also called Tangningtongluo Pian and Tangningtongluo Gao
Tangningtongluo(TNTL) , a traditional botanical ethnic medicine, composed of plantain, honeysuckle, agrimony, etc. It is famous for its effects of promoting blood circulation, dredging collaterals, reducing thirst and lowering glucose.There are two dosage forms: tablet and cream.
Tangningtongluo tabletDrug
Also called Tangningtongluo Pian
Tangningtongluo(TNTL) , a traditional botanical ethnic medicine, composed of plantain, honeysuckle, agrimony, etc. It is famous for its effects of promoting blood circulation, dredging collaterals, reducing thirst and lowering glucose.The participants in this arm use tablet.
Tangningtongluo creamDrug
Also called Tangningtongluo Gao
Tangningtongluo(TNTL) , a traditional botanical ethnic medicine, composed of plantain, honeysuckle, agrimony, etc. It is famous for its effects of promoting blood circulation, dredging collaterals, reducing thirst and lowering glucose.The participants in this arm use cream.
| Study group | Role | What they receive |
|---|---|---|
| Standardized Western Medicine Treatment Group | Active comparator | All participants undergo a similar treatment protocol for the diabetic foot, based on the Infectious Diseases Society of America (IDSA). Receives: Drug: Standardized Western Medicine Treatment |
| Standardized Western Medicine Treatment +TNTL tablet+TNTL cream Group | Experimental | Treatment with TNTL tablets:the oral administration of TNTL tablets, 4 tablets each time, 3 times a day. Treatment with TNTL cream: topical application of sterile TNTL cream on the wound surface, the dressing is continuously changed according to the wound healing. Receives: Drug: Standardized Western Medicine Treatment; Drug: Tangningtongluo tablet and cream |
| Standardized Western Medicine Treatment +TNTL tablet Group | Experimental | Treatment with TNTL tablets:the oral administration of TNTL tablets, 4 tablets each time, 3 times a day. Receives: Drug: Standardized Western Medicine Treatment; Drug: Tangningtongluo tablet |
| Standardized Western Medicine Treatment +TNTL cream Group | Experimental | Treatment with TNTL cream: topical application of sterile TNTL cream on the wound surface, the dressing is continuously changed according to the wound healing. Receives: Drug: Standardized Western Medicine Treatment; Drug: Tangningtongluo cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease area of wound healing due to Diabetic Foot Ulcer
Assessment the decrease of whole area of diabetic foot ulcers. The unit is square centimeters .
Measured: 12 weeks
Decrease of depth of ulcer involve the deep fascia.
Measurement of depth of ulcer involve the deep fascia. The unit is millimeters.
Measured: 12 weeks
Amputation Rate
The difference of end-stage amputation rates between the experimental group and the control group were evaluated by the arterial and venous blood circulation of the lower limbs
Measured: 12 weeks
Diabetic Foot Ulcer relapse rate
The relapse of Diabetic Foot Ulcers is a common complication in the advanced stage of DFU. The difference of treatment between the experimental group and the control group indicates that the prognosis is variability.
Measured: 12 weeks
Secondary outcomes (8)
Fasting glucose
10 hours after fasting peripheral blood glucose level, and the unit is mmol/L
Measured: 12 weeks
2-H postload glucose
2 hours after peripheral blood glucose level eating 75g glucose or 100g steamed bread, and the unit is mmol/L
Measured: 12 weeks
BMI Index
The calculation formula of Body Mass Index is: BMI = weight ÷ height 2. (weight in kilograms; height in meters.)
Measured: 12 weeks
WHR Index
Waist to hip ratio (WHR) = waist / hip.Waist circumference or minimum waist circumference shall be used for measurement, and evaluation of WHR is an important value to central obesity.
Measured: 12 weeks
Islet B cell function
The ability of islet B cells to secrete insulin was reflected by the level of C peptide, which is measured after fasting. The unit is ng/dL .
Measured: 12 weeks
interleukin-6(IL-6)
Determine the level of interleukin-6(IL-6) in peripheral blood by ELISA, the unit is ng/L.
Measured: 12 weeks
tumour necrosis factor-α(TNF-α)
Determine the level of TNF-α in peripheral blood , the unit is ng/ml.
Measured: 12 weeks
C-reactive protein(CRP)
Determine the level of C-reactive protein(CRP) in peripheral blood , the unit is μg/L.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start15 Jan 2022
- Primary completion30 Dec 2022 (estimated)
- Study completion31 Mar 2023 (estimated)
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.
- More trials run by Affiliated Hospital of Nantong UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05145140
- Sponsor's protocol ID
- TNTL on diabetic foot ulcer
- Status last verified
- Sep 2021
- First submitted
- 2 Sep 2021
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Intervention Study of Tangningtongluo on Diabetic Foot Ulcer
- ClinicalTrials.gov ID
- NCT05145140
- Acronym / sponsor ID
- TNTL on diabetic foot ulcer
- Conditions
- Diabetic Foot Ulcer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 6 Dec 2021 (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.
Purpose and significance:With the increasing incidence of Diabetes mellitus (DM), the incidence rate of Diabetic Foot (DF) is raised. DF is a foot infection, ulceration and / or deep tissue destruction caused by nerve abnormalities and varying degrees of vascular lesions in DM patients. The high incidence, disability and mortality rate of DF make it urgent to explore new ways to improve the cure rate, reduce the burden and elevate the quality of life. Previous studies have confirmed that traditional Miao ethic medicine Tangningtongluo(TNTL) can improve the remission rate of diabetes mellitus and diabetic foot disease, but the clinical research evidence is not sufficient. This study aims to provide effective clinical evidence for the treatment of diabetic foot patients with TNTL by observing growth rate of wound, prognosis and outcome.
Methods: From September 2021 to March 2023, a total of 80 diabetic foot ulcer patients admitted to Department of Endocrinology and Metabolism at the Affiliated Hospital of Nantong University were recruited. Participants are randomized in a ratio of 1: 1: 1:1 into four treatment groups of 20 participants: (i) standardized western medicine treatment group, (ii) standardized western medicine treatment+TNTL tablet+TNTL cream group , (iii) standardized western medicine treatment+TNTL tablet group, and (iiii) standardized western medicine treatment+TNTL cream group. Treatment with TNTL tablets: the oral administration of TNTL tablets, 4 tablets each time, 3 times a day. Treatment with TNTL cream: topical application of sterile TNTL cream on the wound surface, the dressing is continuously changed according to the wound healing. Anthropometric parameters, serum biochemical index, glycosylated hemoglobin, urinary microalbumin/creatinine ratio, islet-specific autoantibodies(ISAs), fat mass, and islet β-cell function were measured. The healing stage of the wound surface and the growth degree of granulation tissue were graded, and the time required for wound repairing to each healing stage was observed.
Type of study: randomized controlled, prospective,intervention study.
Detailed description
From September 2021 to March 2023, a total of 80 diabetic foot ulcer patients admitted to Department of Endocrinology and Metabolism at the Affiliated Hospital of Nantong University were recruited. Participants are randomized in a ratio of 1: 1: 1:1 into four treatment groups of 20 participants: (i) standardized western medicine treatment group, (ii) standardized western medicine treatment+TNTL tablet+TNTL cream group , (iii) standardized western medicine treatment+TNTL tablet group, and (iiii) standardized western medicine treatment+TNTL cream group. Treatment with TNTL tablets: the oral administration of TNTL tablets, 4 tablets each time, 3 times a day. Treatment with TNTL cream: topical application of sterile TNTL cream on the wound surface, the dressing is continuously changed according to the wound healing. Anthropometric parameters, serum biochemical index, glycosylated hemoglobin, urinary microalbumin/creatinine ratio, islet-specific autoantibodies(ISAs), fat mass, and islet β-cell function were measured. The healing stage of the wound surface and the growth degree of granulation tissue were graded, and the time required for wound repairing to each healing stage was observed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standardized Western Medicine Treatment Group | Active comparator | Drug: Standardized Western Medicine TreatmentAll participants undergo a similar treatment protocol for the diabetic foot, based on the Infectious Diseases Society of America (IDSA). |
| Standardized Western Medicine Treatment +TNTL tablet+TNTL cream Group | Experimental | Drug: Standardized Western Medicine Treatment, Drug: Tangningtongluo tablet and creamTreatment with TNTL tablets:the oral administration of TNTL tablets, 4 tablets each time, 3 times a day. Treatment with TNTL cream: topical application of sterile TNTL cream on the wound surface, the dressing is continuously changed according to the wound healing. |
| Standardized Western Medicine Treatment +TNTL tablet Group | Experimental | Drug: Standardized Western Medicine Treatment, Drug: Tangningtongluo tabletTreatment with TNTL tablets:the oral administration of TNTL tablets, 4 tablets each time, 3 times a day. |
| Standardized Western Medicine Treatment +TNTL cream Group | Experimental | Drug: Standardized Western Medicine Treatment, Drug: Tangningtongluo creamTreatment with TNTL cream: topical application of sterile TNTL cream on the wound surface, the dressing is continuously changed according to the wound healing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of Type 2 diabetes mellitus
- Clinical diagnosis of Diabetic Foot Ulcer
Key exclusion criteria (7 listed)
- Type 1 diabetes mellitus(T1DM), special type of diabetes, gestational diabetes mellitus, drug-induced hyperglycemia
- TNTL allergy
- Chronic kidney failure（eGFR≤30ml/min/1.73cm2）, severe liver function damage (transaminase ≥ 3 times the normal value), acute or chronic pancreatitis, autoimmune disease, malignant tumors
- Recent acute complications of type 2 diabetes mellitus（ketoacidosis, hyperosmolar nonketotic diabetic coma, lactic acidosis etc.）or other emergency situations
- History of using glucocorticoids and immunosuppressants
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 |
|---|---|---|
| Standardized Western Medicine TreatmentAlso: Classic Diabetic Foot Ulcer treatmentStandardized Western Medicine Treatment includes hypoglycemic, debridement and anti infection treatments. | Drug | Standardized Western Medicine Treatment +TNTL cream Group, Standardized Western Medicine Treatment +TNTL tablet Group, Standardized Western Medicine Treatment +TNTL tablet+TNTL cream Group, Standardized Western Medicine Treatment Group |
| Tangningtongluo tablet and creamAlso: Tangningtongluo Pian and Tangningtongluo GaoTangningtongluo(TNTL) , a traditional botanical ethnic medicine, composed of plantain, honeysuckle, agrimony, etc. It is famous for its effects of promoting blood circulation, dredging collaterals, reducing thirst and lowering glucose.There are two dosage forms: tablet and cream. | Drug | Standardized Western Medicine Treatment +TNTL tablet+TNTL cream Group |
| Tangningtongluo tabletAlso: Tangningtongluo PianTangningtongluo(TNTL) , a traditional botanical ethnic medicine, composed of plantain, honeysuckle, agrimony, etc. It is famous for its effects of promoting blood circulation, dredging collaterals, reducing thirst and lowering glucose.The participants in this arm use tablet. | Drug | Standardized Western Medicine Treatment +TNTL tablet Group |
| Tangningtongluo creamAlso: Tangningtongluo GaoTangningtongluo(TNTL) , a traditional botanical ethnic medicine, composed of plantain, honeysuckle, agrimony, etc. It is famous for its effects of promoting blood circulation, dredging collaterals, reducing thirst and lowering glucose.The participants in this arm use cream. | Drug | Standardized Western Medicine Treatment +TNTL cream Group |
Primary outcome
Decrease area of wound healing due to Diabetic Foot Ulcer
Time frame: 12 weeks
Assessment the decrease of whole area of diabetic foot ulcers. The unit is square centimeters .
Decrease of depth of ulcer involve the deep fascia.
Time frame: 12 weeks
Measurement of depth of ulcer involve the deep fascia. The unit is millimeters.
Amputation Rate
Time frame: 12 weeks
The difference of end-stage amputation rates between the experimental group and the control group were evaluated by the arterial and venous blood circulation of the lower limbs
Diabetic Foot Ulcer relapse rate
Time frame: 12 weeks
The relapse of Diabetic Foot Ulcers is a common complication in the advanced stage of DFU. The difference of treatment between the experimental group and the control group indicates that the prognosis is variability.
8 secondary outcomes
Fasting glucose
Time frame: 12 weeks
2-H postload glucose
Time frame: 12 weeks
BMI Index
Time frame: 12 weeks
WHR Index
Time frame: 12 weeks
Islet B cell function
Time frame: 12 weeks
interleukin-6(IL-6)
Time frame: 12 weeks
tumour necrosis factor-α(TNF-α)
Time frame: 12 weeks
C-reactive protein(CRP)
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Standardized Western Medicine Treatment, Tangningtongluo tablet and cream and Tangningtongluo tablet in people with Diabetic Foot Ulcer, run by Affiliated Hospital of Nantong University at 1 site in China.
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 18 Mar 2022. 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 China. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease area of wound healing due to Diabetic Foot Ulcer (time frame: 12 weeks). The study lists 4 primary outcomes in all. 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 18 Mar 2022.