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A Clinical Intervention Study of Tangningtongluo on Diabetic Foot Ulcer

4 mars 2022 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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 d'étude

Interventionnel

Inscription (Anticipé)

80

Phase

  • La phase 1

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Chine
    • Jiangsu
      • Nantong, Jiangsu, Chine, 226001
        • Recrutement
        • Gu Yunjuan
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 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).
Médicament: Standardized Western Medicine Treatment
Standardized Western Medicine Treatment includes hypoglycemic, debridement and anti infection treatments.
Autres noms:
  • Classic Diabetic Foot Ulcer treatment
Expérimental: 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.
Médicament: Standardized Western Medicine Treatment
Standardized Western Medicine Treatment includes hypoglycemic, debridement and anti infection treatments.
Autres noms:
  • Classic Diabetic Foot Ulcer treatment
Médicament: 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.
Autres noms:
  • Tangningtongluo Pian and Tangningtongluo Gao
Expérimental: 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.
Médicament: Standardized Western Medicine Treatment
Standardized Western Medicine Treatment includes hypoglycemic, debridement and anti infection treatments.
Autres noms:
  • Classic Diabetic Foot Ulcer treatment
Médicament: 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.
Autres noms:
  • Tangningtongluo Pian
Expérimental: 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.
Médicament: Standardized Western Medicine Treatment
Standardized Western Medicine Treatment includes hypoglycemic, debridement and anti infection treatments.
Autres noms:
  • Classic Diabetic Foot Ulcer treatment
Médicament: 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.
Autres noms:
  • Tangningtongluo Gao

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Decrease area of wound healing due to Diabetic Foot Ulcer
Délai: 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.
Délai: 12 weeks
Measurement of depth of ulcer involve the deep fascia. The unit is millimeters.
12 weeks
Amputation Rate
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Fasting glucose
Délai: 12 weeks
10 hours after fasting peripheral blood glucose level, and the unit is mmol/L
12 weeks
2-H postload glucose
Délai: 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
Délai: 12 weeks
The calculation formula of Body Mass Index is: BMI = weight ÷ height 2. (weight in kilograms; height in meters.)
12 weeks
WHR Index
Délai: 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
Délai: 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)
Délai: 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)
Délai: 12 weeks
Determine the level of TNF-α in peripheral blood , the unit is ng/ml.
12 weeks
C-reactive protein(CRP)
Délai: 12 weeks
Determine the level of C-reactive protein(CRP) in peripheral blood , the unit is μg/L.
12 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Affiliated Hospital of Nantong University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

15 janvier 2022

Achèvement primaire (Anticipé)

30 décembre 2022

Achèvement de l'étude (Anticipé)

31 mars 2023

Dates d'inscription aux études

Première soumission

2 septembre 2021

Première soumission répondant aux critères de contrôle qualité

2 décembre 2021

Première publication (Réel)

6 décembre 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

18 mars 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

4 mars 2022

Dernière vérification

1 septembre 2021

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • TNTL on diabetic foot ulcer

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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