A Clinical Intervention Study of Tangningtongluo on Diabetic Foot Ulcer
Status:
Not yet recruiting
Trial end date:
2023-03-31
Target enrollment:
Participant gender:
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.