Review Article

Advances in Topical Chinese Herbal Medicine Formulas for Treating Diabetic Foot Ulcers

DOI:

10.3791/69239

⸱

February 27th, 2026

 ,  ,  ,  ,  ,  ,  ,  ,  ,  ,  , 
1Department of Geriatrics, Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University, 2Department of Orthopedics, The first affiliated hospital of Zhejiang University, 3Department of Orthopedics, The second affiliated hospital of Zhejiang Chinese Medical University, 4Department of Orthopedics, Third Xiangya Hospital of Central South University, 5Department of School of Medicine, Zhejiang University, 6Department of General Surgery, Salmaniya Medical Complex, 7Department of Orthopedic Physical Therapy, Faculty of Physical Therapy, Nahda University, 8Department of Nuclear Medicine, The first affiliated hospital of Zhejiang University

* These authors contributed equally

In This Article

Summary

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This article reviews the use of topical Chinese herbal medicine (CHM) for diabetic foot ulcers, highlighting current clinical challenges, recent evidence, therapeutic mechanisms, and the potential role of CHM as an integrative strategy to enhance wound healing and reduce complications.

Abstract

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The prevalence of diabetic foot ulcers (DFU), one of the most common complications of diabetes mellitus (DM), varies significantly across different countries, but remains high globally. The presence of DFU is associated with escalated healthcare expenditures, compromised physical functioning, and diminished quality of life, with a 5-year mortality rate 2.5 times higher than diabetes patients without foot ulcers. Common therapeutic strategies for DFU include glycemic control, eradication of infections, alleviation of pressure on the ulcers, and facilitation of wound healing. CHM, a fundamental element of Traditional Chinese Medicine, has gained widespread recognition in both oral and topical applications for the management of chronic wounds, owing to its functions of detoxification, promotion of blood circulation, removal of blood stasis, and enhancement of wound healing, as outlined in Chinese Medicine theories. Therefore, it is imperative to conduct a comprehensive literature review on the utilization of topical CHM for treating DFU in order to provide evidence-based guidance for clinical practice.

Introduction

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Diabetes mellitus (DM) has become one of the most pressing global health challenges, affecting an estimated 537 million adults in 2021, with projections suggesting this number will reach around 783 million by 20451. As the most commonly recognized complication of diabetes2, the prevalence of DFU varies significantly across different countries, but a commonality exists in that the prevalence of DFU remains high. The prevalence in African countries typically ranges from 10% to 30%, while in certain high-income regions, it accounts for 1% to 17%1. The presence of DFU is associated with escalated healthcare expenditures, compromised physical functioning, and diminished quality of life2. Patients with DFU have a 2.5-fold higher 5-year mortality rate compared with diabetic patients without ulcers3. Over 50% of ulcers develop infections, while approximately 20% of moderate or severe diabetic foot infections result in varying degrees of amputation4. The financial consequences are also staggering: annual direct and indirect costs of diabetes care in the United States alone reach $273 billion and $90 billion, respectively5, with DFU accounting for a substantial portion due to repeated outpatient visits, prolonged hospitalizations, and long-term wound care needs6,7,8 (Figure 1).

Despite the availability of standard clinical treatments -- including glycemic control, infection management, mechanical off-loading, and wound-healing promotion -- these strategies often fall short for chronic, non-healing ulcers9,10. In recent years, interest has grown in complementary and integrative medicine approaches, particularly CHM, which forms the cornerstone of Traditional Chinese Medicine11. Rooted in holistic principles, CHM emphasizes detoxification, promotes blood circulation, removes stasis, and enhances tissue regeneration. Both oral formulations and topical preparations of CHM are increasingly used in clinical practice for chronic wound management12. However, despite accumulating evidence and clinical use, the therapeutic mechanisms, efficacy profiles, and standardization challenges of topical CHM for DFU remain incompletely understood.

Against this background, this review aims to provide a comprehensive and critical overview of topical Chinese herbal medicine in the management of diabetic foot ulcers, summarizing recent advances, clinical outcomes, and underlying biological mechanisms. By integrating evidence from both modern biomedical studies and traditional therapeutic perspectives, this work aims to clarify the potential role of CHM in enhancing wound healing, reducing complications, and contributing to global strategies for diabetic foot care.

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Review and Perspective

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Pathophysiology of DFU
DFU is characterized by a disruption of the epidermis and at least partial involvement of the dermis in individuals with diabetes. Its development is attributed to multifactorial causes, including peripheral artery disease (PAD), diabetic peripheral sensory, motor, and autonomic neuropathy13.

Peripheral neuropathy
Peripheral neuropathy (PN) most commonly presents as symmetric polyneuropathy with pain or paresthesia, though up to 50% of cases may be asymptomatic14. It involves sensory, motor, and autonomic deficits15. Sensory neuropathy causes loss of pain, temperature, and proprioception, increasing unnoticed injuries and abnormal gait16. Motor neuropathy induces muscle atrophy-especially of extensors-leading to deformities, gait abnormalities, and pressure-related ulcers16. Autonomic neuropathy reduces sweating, causing dry, fissured skin and impaired vasoconstriction, which leads to edema and delayed wound healing17.

Peripheral artery disease (PAD)
PAD refers to the stenosis or occlusion of blood vessels in the extremities, typically the lower limbs, leading to diminished perfusion11,19. Its development and acceleration are closely linked to diabetes19 and result in the manifestations of a distinctive phenotype in PAD20. In contrast to individuals without diabetes, individuals with diabetes who have PAD are more susceptible to experiencing extensive arterial blockages that span long segments18. Moreover, they exhibit medial arterial calcification instead of the intraluminal atherosclerosis commonly observed in nondiabetic PAD21. The presence of PAD plays a pivotal role in approximately 50%-70% of cases involving DFU, thereby presenting a significant risk for delayed wound healing, infection, the necessity for amputation, and mortality22,23 (Figure 2).

Chinese herbal formula
The practice of Traditional Chinese Medicine (TCM), rooted in Oriental philosophy and culture, encompasses a range of modalities, including acupuncture, therapeutic exercises, herbal medicine, dietary therapy, and massage, for both curative and preventive purposes. TCM is recognized as a form of complementary and alternative medicine in Western countries24. In the extensive chronicles of Chinese history, TCM, specifically topical application of Chinese herbal remedies, has been extensively employed for the management of diabetic foot ulcers, exhibiting favorable outcomes and presenting numerous advantages such as convenience and cost-effectiveness25.

Topical medicine (Table 1)
Tangzu Yuyang Ointment
Tangzu Yuyang Ointment (TYO), a topical CHM, consists of two natural minerals and nine herbs26. The components include Duanshigao (Gypsum fibrosum praeparatum), Xuejie (Daemonorops draco Bl), Chuanxiong (Ligusticum chuanxiong Hort), Huanglian (Coptis chinensis Franch), Cangzu (Atractylodes lancea), Sanqi (Panax notoginseng), Danggui (Angelica sinensis), Zicao (Arnebia euchroma), Huangbo (Phellodendron chinense Schneid), Dahuang (Rheum officinale Baill), Bingpian (Borneolum syntheticum). Sesame oil and Beeswax as used as the base constituents.

A randomized controlled study was conducted by Li et al., which included diabetic patients with grade 1-3 DFU according to Wagner's classification, excluding those with ischemic involvement26. The study, comprising a total of 57 patients, was stratified into two cohorts: standard wound treatment (SWT) and SWT supplemented with TYO. The results demonstrated that there was a significant improvement in the TYO group at 12 weeks (79.2% vs. 41.7%, p = 0.017) and 24 weeks (91.7% vs. 50%, p = 0.003). In addition, another evaluation revealed a reduction of over 50% in the area of the ulcer, demonstrating a significant difference between the groups at 24 weeks (70.8% vs. 41.7%; p = 0.08)25.

She Xiang Yu Hong ointment
She Xiang Yu Hong (SXYH), as a kind of TCM, is used for the treatment of diabetic foot infection and bedsores in Chinese hospitals for more than decades25. However, limited research has been conducted to assess the impact of SXYH on wound healing. Li et al.27 conducted an investigation to evaluate the efficacy of SXYH using a comprehensive macroscopic approach, which encompassed assessment of wound healing area, examination of pathological sections, analysis of inflammatory factors, and utilization of immunohistochemical methods.

The study27 monitored wound size over a period of 3 weeks. In terms of skin appearance, the SXYH ointment group exhibited superior outcomes. Specifically, at 7 days, the rate of wound healing was significantly accelerated in the SXYH ointment group compared to the control group. The results of Masson's trichrome staining revealed that the collagen fibers in the SXYH ointment-treated group exhibited a significantly greater extent and more organized arrangement compared to those in the untreated group. Furthermore, biopsy results revealed a noticeable reduction in the concentration of TNF-α and IL-6 cytokines, pivotal factors contributing to persistent inflammation, within the SXYH group at 7 days and 14 days. Finally, immunohistochemical staining results demonstrated a significant increase in the positive expression of CD31 and VEGF, both of which are known to contribute to wound healing, at 7 and 14 days within the SXYH group.

Zizhu ointment
Zizhu ointment consists of Zhusa (Cinnabaris), Zicao (Arnebia guttata Bunge), Huangqi (Astragalus mongholicus Bunge), Ejiao (Asini corii colla), Bingpian (Borneolum), and Xuejie (Calamus draco Willd)28. It has demonstrated its efficacy in significantly improving the cure rate for chronic ulcers in the lower limbs across numerous cases29.

In order to assess the efficacy of Zizhu ointment in enhancing wound healing in diabetic models, Han et al. devised an experimental design that simulated diabetic wound healing by inducing burns on non-diabetic or diabetic rats using a heated metal plate29. Subsequently, the rats were categorized into two groups: wounded rats (group A) and diabetic wounded rats (group D). The diabetic wounded rats were inoculated with a combination of S. aureus or P. aeruginosa and subsequently referred to as the Infectious Wounded Rat group (Group F). Varying dosages of Zizhu ointment were topically administered to the injured area for a duration of 2 weeks. The levels of inflammatory response-related factors, such as CRP, IL6, and NO, exhibited a significant decrease in both group D and group F. In addition, the groups treated with Zizhu ointment exhibited a decrease in the expression of angiogenic factors, including CD34 and VEGF. Previous studies28,30 have reported an increase in NF-κB, JNK, and PI3K proteins within wound tissues of diabetic individuals. After treatment with different doses of Zizhu ointment, the activation levels of PI3K, P65, and JNK were significantly reduced (Figure 3, Figure 4).

Shengji ointment
Shengji ointment consists of Danggui (Angelica sinensis), Dihuang (Rehmannia glutinosa), Shigao (Gypsum fibrosum), Xueyutan (Crinis carbonisatus), calamina, and beeswax. Zhao et al. conducted a multicenter, randomized controlled trial, which recruited 180 patients with diabetic foot ulcers classified as Wagner grade 3-4 from four hospitals31. In addition to routine medical and surgical treatment, including glycemic control, blood pressure reduction, and debridement, the intervention group received topical application of Shengji ointment, while the control group was treated with a hydrocolloid dressing for wound coverage. After a 4-week observation period, the study concluded that the application of Chinese herbal Shengi ointment appears to promote granulation tissue formation, thereby accelerating the wound healing process.

Jing Wan Hong ointment
Jin Wan Hong comprises approximately 30 Chinese herbal components, including Radix Ampelopsis, Angelica dahurica, Chinese lobelia, Borneol, Rhizoma Atractylodis, Red Peony Root, Rhizoma Ligustici Chuanxiong, and Pangolin. The formula exerts effects of promoting blood circulation to eliminate stasis, clearing heat, resolving dampness, and reducing swelling through detoxification, thereby facilitating ulcer healing32.

To investigate its therapeutic efficacy in diabetic foot ulcers associated with nerve injury, Jin et al. established a Wistar rat model induced by streptozotocin injection combined with sciatic nerve clamp injury. The animals were divided into four groups: diabetic control (DC), diabetic nerve injury model (DNIM), Jing Wan Hong (JWH) treatment, and recombinant human epidermal growth factor (rhEGF) as a positive control. The ointment was applied topically once daily for 21 days32. Macroscopic observation revealed that rats in the JWH group exhibited marked reductions in foot ulcer size and Wagner grade, with wound closure exceeding 80% after 21 days of treatment-comparable to the rhEGF-treated group. Histological examination confirmed re-epithelialization, reduction of inflammatory infiltration, and restoration of dermal structure, contrasting sharply with the persistent necrosis and exudation observed in the DNIM group. At the molecular level, Jing Wan Hong significantly upregulated platelet-derived growth factor (PDGF) mRNA, a key mediator in wound repair, while exerting minimal influence on TGF-β, VEGF, or FLT-1 expression32. The increased PDGF expression likely contributed to enhanced fibroblast proliferation, angiogenesis, and extracellular matrix remodeling, accelerating wound closure without affecting systemic glucose levels (Figure 5).

Perspective on the use of TCM
Although current literature suggests that Chinese herbal medicine may have a positive impact on the treatment of diabetic foot ulcers, numerous studies33,34 suffer from limitations such as small sample sizes and imprecise study designs35. These issues raise concerns regarding the reliability and validity of the conclusion.

Traditional CHM usually contains multiple active ingredients, which may interact with each other. There may also be variations in the composition and concentration of these ingredients among different batches of the same drug. This complexity makes standardization difficult and increases the risk of side effects and drug allergies36. Although traditional Chinese herbal medicine is generally regarded as natural and safe, the topical application of these herbs may still elicit local irritation, allergic reactions, or other dermatological complications. This is particularly pertinent for individuals with diabetes whose skin tends to exhibit heightened fragility and sensitivity towards external irritants and infections37. Consequently, exercising additional caution when employing topical herbal preparations is imperative.

The mechanism of action and clinical efficacy of the topical application of traditional Chinese herbal medicine remain incompletely elucidated, with a dearth of effective monitoring methods and standards, posing challenges in quantifying and evaluating treatment outcomes38. Simultaneously, interindividual variations may lead to divergent responses among patients despite receiving the same treatment regimen. The absorption efficiency of topical medications is limited by the barrier function of the skin, especially in diabetic skin lesions, where transdermal drug absorption may be more challenging, affecting treatment efficacy37. Additionally, delivering active ingredients stably to the affected areas is also a technical challenge. The application of traditional CHM for the topical treatment of diabetes has not yet established a standardized framework and guideline, hindering the provision of systematic and scientifically guided care. Clinical practitioners and patients often rely on experiential knowledge and traditional therapies, which compromise consistency and normativity in the treatment process.

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Conclusions

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The topical application of traditional CHM shows promising therapeutic potential in diabetic wound management, yet its clinical translation remains constrained by limited evidence quality and a lack of standardization. Most existing studies suffer from small sample sizes, inadequate controls, and heterogeneous formulations, making it difficult to draw firm conclusions regarding efficacy and safety. Standardization challenges -- including inconsistent raw material quality, variability in active compound concentrations, an...

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Disclosures

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The authors declare that they have no competing interests.

Acknowledgements

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Not applicable

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Tags

Diabetic Foot UlcersChinese Herbal MedicineTopical Herbal FormulasWound HealingBlood CirculationChronic Wound ManagementTraditional Chinese MedicineGlycemic ControlInfection EradicationBlood Stasis Removal

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