Clinical study for external washing by traditional Chinese medicine in the treatment of multiple infectious wounds of diabetic foot

Abstract

Background: Diabetic foot (DF) is among the most serious complications of type 2 diabetes. DF infection (DFI) is a key factor in the deterioration and development of DF, so controlling infection plays an important role in the treatment of the disease. Traditional Chinese medicine foot bath has been widely used in China as a complementary and alternative therapy to improve circulation and infection control of DF. However, the existing evidence shows that its efficacy and safety are still insufficient. We report a study protocol about a multicenter, double-blind, randomized, placebo controlled trial which aims to make well-designed clinical trials to evaluate the efficacy and safety of herbal medicine foot bath decoction (FBD) and explore the mechanism of external washing of Chinese herbs in DFI. Methods: This study is a multicenter, double-blind, randomized, placebo controlled clinical trial in which 60 eligible participants were randomly divided into an experimental group and control group at a 1:2 ratio. Both groups received the same basic treatment for DF disease, the experimental group used FBD and ordinary dressing changes, while half of the patients in the control group received placebo and ordinary dressings, and the other half received placebo and silver ion dressings. Patients in both groups will be evaluated weekly for efficacy during the intervention. The primary efficacy indicators include the types of wound pathogens, interleukin 6 and tumor necrosis factor α. Secondary efficacy indicators included blood glucose, blood lipids, wound area, lower extremity blood vessel diameter, blood flow speed, walking speed, walking distance, and traditional Chinese medicine syndrome scores. We will also conduct a safety evaluation of the drug at the end of the trial. Discussion: This multicenter, double-blind, randomized, placebo clinical trial not only provides data on the efficacy and safety of FBD, but also provides a novel treatment strategy for clinicians and DF patients.

Advances in traditional Chinese medicine as adjuvant therapy for diabetic foot

“…TCM foot bath using decoctions increases blood circulation for Grade 0 DF[ 68 ]. Additionally, herbal foot baths can improve local microcirculation and regulate skin permeability to increase drug absorption, thus effectively increasing drug concentration[ 69 , 70 ].…”

“…Additionally, herbal foot baths can improve local microcirculation and regulate skin permeability to increase drug absorption, thus effectively increasing drug concentration[ 69 , 70 ]. Recently, clinical trials have been designed to examine the efficacy and safety of TCM foot baths[ 68 , 71 ]. Nevertheless, foot baths can spread infection at the ulcer site in patients with chronic limb ulcers and increase the rate of toe loss (53%) and major amputation (30%)[ 72 ].…”

More studies are necessary to establish the effectiveness of Jinhuang powder in the treatment of diabetic foot

“…Previous study found that a group of traditional Chinese medicine (TCM) ( e.g. , herbal medicine foot bath decoction[ 5 ], TCM injections[ 6 , 7 ], Chinese herbal medicine ulcer oil[ 8 ], moxibustion[ 9 ], Astragali Radix and Rehmanniae Radix Mixture[ 10 ], the peptide compounds of Wuguchong[ 11 ], Astragali Radix and Rehmanniae Radix[ 12 , 13 ]) played an important role in the treatment of the disease. Some study also found that interventional radiology plays a crucial role in the treatment of diabetic foot disease[ 14 ].…”

“…In recent years, most diabetic foot patients in China are adopting TCM and western medicine[ 5 , 15 ]. A series of systematic review articles showed that TCM can increase the clinical effective rate of conventional therapies by 27%[ 6 ], regulate the signaling pathways to promote diabetic wound healing[ 16 ].…”

Production of an Animal Model of Semi-Yin and Semi-Yang Syndrome with Diabetic Ulcers and Study of Its Pathological and Metabolic Features

“…Many traditional Chinese medicine (TCM) ointments effectively treat diabetic ulcers, and they show a more significant curative effect during the early stages of treatment than in the later stages [ 3 ]. However, most Chinese herbal preparations for external application show intended results only after the correct differentiation of TCM syndrome.…”