A Clinical Intervention Study of Tangningtongluo on Diabetic Foot Ulcer
NCT ID: NCT05145140
Last Updated: 2022-03-18
Study Results
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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UNKNOWN
PHASE1
80 participants
INTERVENTIONAL
2022-01-15
2023-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standardized Western Medicine Treatment Group
All participants undergo a similar treatment protocol for the diabetic foot, based on the Infectious Diseases Society of America (IDSA).
Standardized Western Medicine Treatment
Standardized Western Medicine Treatment includes hypoglycemic, debridement and anti infection treatments.
Standardized Western Medicine Treatment +TNTL tablet+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.
Standardized Western Medicine Treatment
Standardized Western Medicine Treatment includes hypoglycemic, debridement and anti infection treatments.
Tangningtongluo tablet and cream
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.
Standardized Western Medicine Treatment +TNTL tablet Group
Treatment with TNTL tablets:the oral administration of TNTL tablets, 4 tablets each time, 3 times a day.
Standardized Western Medicine Treatment
Standardized Western Medicine Treatment includes hypoglycemic, debridement and anti infection treatments.
Tangningtongluo tablet
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.
Standardized Western Medicine Treatment +TNTL cream Group
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
Standardized Western Medicine Treatment includes hypoglycemic, debridement and anti infection treatments.
Tangningtongluo cream
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.
Interventions
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Standardized Western Medicine Treatment
Standardized Western Medicine Treatment includes hypoglycemic, debridement and anti infection treatments.
Tangningtongluo tablet and cream
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 tablet
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 cream
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of Diabetic Foot Ulcer
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Affiliated Hospital of Nantong University
OTHER
Responsible Party
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Locations
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Gu Yunjuan
Nantong, Jiangsu, China
Countries
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Facility Contacts
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Other Identifiers
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TNTL on diabetic foot ulcer
Identifier Type: -
Identifier Source: org_study_id
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