A Clinical Intervention Study of Tangningtongluo on Diabetic Foot Ulcer
1 other identifier
interventional
80
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 2, 2021
CompletedFirst Posted
Study publicly available on registry
December 6, 2021
CompletedStudy Start
First participant enrolled
January 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2023
CompletedMarch 18, 2022
September 1, 2021
12 months
September 2, 2021
March 4, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
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 .
12 weeks
Decrease of depth of ulcer involve the deep fascia.
Measurement of depth of ulcer involve the deep fascia. The unit is millimeters.
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
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.
12 weeks
Secondary Outcomes (8)
Fasting glucose
12 weeks
2-H postload glucose
12 weeks
BMI Index
12 weeks
WHR Index
12 weeks
Islet B cell function
12 weeks
- +3 more secondary outcomes
Study Arms (4)
Standardized Western Medicine Treatment Group
ACTIVE COMPARATORAll 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
EXPERIMENTALTreatment 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
EXPERIMENTALTreatment with TNTL tablets:the oral administration of TNTL tablets, 4 tablets each time, 3 times a day.
Standardized Western Medicine Treatment +TNTL cream Group
EXPERIMENTALTreatment with TNTL cream: topical application of sterile TNTL cream on the wound surface, the dressing is continuously changed according to the wound healing.
Interventions
Standardized Western Medicine Treatment includes hypoglycemic, debridement and anti infection treatments.
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(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(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.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of Type 2 diabetes mellitus
- Clinical diagnosis of Diabetic Foot Ulcer
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gu Yunjuan
Nantong, Jiangsu, 226001, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2021
First Posted
December 6, 2021
Study Start
January 15, 2022
Primary Completion
December 30, 2022
Study Completion
March 31, 2023
Last Updated
March 18, 2022
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share