A Clinical Intervention Study of Tangningtongluo on Diabetic Foot Ulcer

Diabetic Foot Ulcer Clinical Trial

Official title:

A Clinical Intervention Study of Tangningtongluo on Diabetic Foot Ulcer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05145140
• Other study ID #: TNTL on diabetic foot ulcer
• Status: Recruiting
• Phase: Phase 1
• Start date: January 15, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: September 2021
• Source: Affiliated Hospital of Nantong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 31, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of Type 2 diabetes mellitus

• Clinical diagnosis of Diabetic Foot Ulcer

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Gu Yunjuan	Nantong	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital of Nantong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Decrease of depth of ulcer involve the deep fascia.	Measurement of depth of ulcer involve the deep fascia. The unit is millimeters.	12 weeks
Primary	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
Primary	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	Fasting glucose	10 hours after fasting peripheral blood glucose level, and the unit is mmol/L	12 weeks
Secondary	2-H postload glucose	2 hours after peripheral blood glucose level eating 75g glucose or 100g steamed bread, and the unit is mmol/L	12 weeks
Secondary	BMI Index	The calculation formula of Body Mass Index is: BMI = weight ÷ height 2. (weight in kilograms; height in meters.)	12 weeks
Secondary	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.	12 weeks
Secondary	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 .	12 weeks
Secondary	interleukin-6(IL-6)	Determine the level of interleukin-6(IL-6) in peripheral blood by ELISA, the unit is ng/L.	12 weeks
Secondary	tumour necrosis factor-a(TNF-a)	Determine the level of TNF-a in peripheral blood , the unit is ng/ml.	12 weeks
Secondary	C-reactive protein(CRP)	Determine the level of C-reactive protein(CRP) in peripheral blood , the unit is µg/L.	12 weeks