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A Clinical Intervention Study of Tangningtongluo on Diabetic Foot Ulcer

4 mars 2022 uppdaterad av: Affiliated Hospital of Nantong University

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Förväntat)

80

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Kina
    • Jiangsu
      • Nantong, Jiangsu, Kina, 226001
        • Rekrytering
        • Gu Yunjuan
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: 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).
Läkemedel: Standardized Western Medicine Treatment
Standardized Western Medicine Treatment includes hypoglycemic, debridement and anti infection treatments.
Andra namn:
  • Classic Diabetic Foot Ulcer treatment
Experimentell: 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.
Läkemedel: Standardized Western Medicine Treatment
Standardized Western Medicine Treatment includes hypoglycemic, debridement and anti infection treatments.
Andra namn:
  • Classic Diabetic Foot Ulcer treatment
Läkemedel: 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.
Andra namn:
  • Tangningtongluo Pian and Tangningtongluo Gao
Experimentell: 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.
Läkemedel: Standardized Western Medicine Treatment
Standardized Western Medicine Treatment includes hypoglycemic, debridement and anti infection treatments.
Andra namn:
  • Classic Diabetic Foot Ulcer treatment
Läkemedel: 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.
Andra namn:
  • Tangningtongluo Pian
Experimentell: 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.
Läkemedel: Standardized Western Medicine Treatment
Standardized Western Medicine Treatment includes hypoglycemic, debridement and anti infection treatments.
Andra namn:
  • Classic Diabetic Foot Ulcer treatment
Läkemedel: 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.
Andra namn:
  • Tangningtongluo Gao

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Decrease area of wound healing due to Diabetic Foot Ulcer
Tidsram: 12 weeks
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.
Tidsram: 12 weeks
Measurement of depth of ulcer involve the deep fascia. The unit is millimeters.
12 weeks
Amputation Rate
Tidsram: 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
12 weeks
Diabetic Foot Ulcer relapse rate
Tidsram: 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.
12 weeks

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Fasting glucose
Tidsram: 12 weeks
10 hours after fasting peripheral blood glucose level, and the unit is mmol/L
12 weeks
2-H postload glucose
Tidsram: 12 weeks
2 hours after peripheral blood glucose level eating 75g glucose or 100g steamed bread, and the unit is mmol/L
12 weeks
BMI Index
Tidsram: 12 weeks
The calculation formula of Body Mass Index is: BMI = weight ÷ height 2. (weight in kilograms; height in meters.)
12 weeks
WHR Index
Tidsram: 12 weeks
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
Islet B cell function
Tidsram: 12 weeks
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
interleukin-6(IL-6)
Tidsram: 12 weeks
Determine the level of interleukin-6(IL-6) in peripheral blood by ELISA, the unit is ng/L.
12 weeks
tumour necrosis factor-α(TNF-α)
Tidsram: 12 weeks
Determine the level of TNF-α in peripheral blood , the unit is ng/ml.
12 weeks
C-reactive protein(CRP)
Tidsram: 12 weeks
Determine the level of C-reactive protein(CRP) in peripheral blood , the unit is μg/L.
12 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Affiliated Hospital of Nantong University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

15 januari 2022

Primärt slutförande (Förväntat)

30 december 2022

Avslutad studie (Förväntat)

31 mars 2023

Studieregistreringsdatum

Först inskickad

2 september 2021

Först inskickad som uppfyllde QC-kriterierna

2 december 2021

Första postat (Faktisk)

6 december 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

18 mars 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 mars 2022

Senast verifierad

1 september 2021

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • TNTL on diabetic foot ulcer

Plan för individuella deltagardata (IPD)

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NEJ

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