Clinical Research Directory

Mailuo Shutong Pills for Diabetic Wound Healing: A Multicenter Randomized Trial

Mailuo Shutong Pills are a Chinese patent medicine approved for market release by the China Food and Drug Administration (CFDA) in 2009. It is formulated by integrating five classical herbal formulas, including Ermiao San, Simiao Yongan Tang, and Zhijing San. Its composition is as follows: Honeysuckle Flower (Jinyinhua) serves as the principal component (Jun herb) for clearing heat and detoxifying; Astragalus Root (Huangqi) for tonifying qi, expelling toxin, and promoting diuresis; Phellodendron Bark (Huangbai), Atractylodes Rhizome (Cangzhu), and Coix Seed (Yiyiren) act as deputy components (Chen herbs) to clear heat and resolve dampness; Chinese Angelica (Danggui), Peony Root (Baishao), and Licorice Root (Gancao) alleviate spasm and pain; Figwort Root (Xuanshen) cools the blood, clears heat, drains fire, detoxifies, and softens hard masses. Leeches (Shuizhi), Centipede (Wugong), and Scorpion (Quanxie) serve as assistant components (Zuo herbs) to invigorate blood, resolve stasis, attack toxicity, dissipate nodules, and unblock collaterals to relieve pain. Licorice Root (Gancao) also harmonizes the various components in the formula as the envoy component (Shi herb). The complete formula possesses the effects of clearing heat and detoxifying, dissolving stasis and unblocking collaterals, and dispelling dampness and reducing swelling. It is indicated for various conditions differentiated in Traditional Chinese Medicine (TCM) as presenting with a pattern of dampness-heat and stasis obstruction, such as superficial thrombophlebitis and deep vein thrombosis in the non-acute stage. Some studies suggest that Mailuo Shutong Pills may have a positive effect in the field of wound healing, for example, by significantly reducing the release of inflammatory mediators such as IL-1β, IL-6, CRP, and TNF-α caused by inflammatory diseases \[11-13\], and accelerating the healing of diabetic foot wounds \[14\]. Clinical guidelines, including the "Clinical Application Guide for Chinese Patent Medicines - Diabetes Volume" from the Diabetes Branch of the China Association of Chinese Medicine and the "Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment Guidelines for Diabetic Foot" from the Chinese Medical Doctor Association, recommend Mailuo Shutong Pills for the treatment of diabetic foot ulcers \[15\]. However, the current related evidence-based medical evidence is insufficient. We have also observed that the adjunctive use of Mailuo Shutong Pills does not guarantee a shortened healing time for all patients with diabetic wounds. From a TCM perspective, the presence of a dampness-heat and stasis obstruction pattern is a key factor determining the efficacy of adjunctive Mailuo Shutong therapy. For Western medicine practitioners, tongue diagnosis presents a practicable factor for assessing pattern manifestation. Therefore, based on differences in patient patterns and using tongue appearance as an inclusion/exclusion criterion, to screen for the indications of Mailuo Shutong Pills combined with existing standard treatment for diabetic wounds constitutes an effective technical approach to address the aforementioned issues. Consequently, this study aims to explore the indications for Mailuo Shutong Pills in diabetic wounds and obtain evidence-based medical evidence for its clinical efficacy within an integrated Chinese-Western medicine approach. Furthermore, to enhance the study's external validity and participant recruitment efficiency, thereby accelerating the research progress, this study is designed as an exploratory trial conducted across multiple centers.

Efficacy of Tetrachlorodecaoxide (TCDO) Drops in Chronic Wound Healing

This is a single-center, randomized controlled trial evaluating the effectiveness of topical tetrachlorodecaoxide (TCDO) solution in enhancing chronic wound healing. The study will compare standard wound care with and without the addition of topical TCDO drops. Eligible adult participants with chronic wounds of more than six weeks' duration will be randomly assigned to either the intervention or control group. The trial aims to assess the rate of wound healing, time to 50% wound closure, pain reduction measured by the Visual Analog Scale (VAS), and cost-effectiveness.

Evaluate Use of Tropocells(R) Autologous Platelet-rich Fibrin (PRF) for Wagner Grade 1 and Grade 2, Mild to Mod Neuroischemic Plantar Diabetic Foot Ulcer Wound Care.

The goal of this investigational study is to evaluate the safety and clinical performance of Tropocells Autologous Platelet-rich Fibrin (PRF) for wound care for both males and females, ages 18-80 years old, with Grade 1 and 2, mild to moderate, neuroischemic diabetic chronic foot ulcers in subjects with Type 1 and Type 2 Diabetes Mellitus. The main question\[s\] it aims to answer \[is/are\]: Measure 1: Wound Closure with Tropocells Autologous PRF System for DFU Measure 2: Safety of Tropocells Autologous PRF System for DFU Researchers will enroll to acquire approximately 30 evaluable subjects with no comparison group. Run-In Phase (2 weeks): participants with chronic diabetic foot wounds will undergo a 2-week run in phase presenting to the clinic for weekly visits, for standard of care. Active Treatment Phase (12 weeks): participants that do not show a reduction of at least 20% may be qualified to advance to the active treatment phase where wounds will be evaluated and treated weekly in the research clinic to receive standard of care with Tropocells Autologous PRF System. Follow-up Phase (1 month and 3 months): participants with wounds that losed during the Active Treatment Phase ( 100% wound closure with two weekly assessments demonstrating persistent closure) will be advanced to the follow-up phase to show if the wound remains closed at 1 month and 3 months.