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Abstract

Diabetic foot ulcers (DFUs) are a prevalent and debilitating complication of diabetes, affecting 15–25% of patients and posing significant clinical and economic burdens. Conventional wound care strategies—including hydrocolloids, foams, antimicrobial dressings, growth factor therapies, and bioengineered skin substitutes—offer partial relief but remain limited by low healing rates, infection control challenges, high costs, and poor patient adherence. Emerging next-generation formulation technologies provide promising solutions to these limitations. Nanotechnology-based carriers, stimuli-responsive hydrogels, electrospun nanofibrous scaffolds, stem cell-derived exosomes, smart sensor-integrated dressings, and 3D-printed scaffolds enable targeted, sustained, and multifunctional therapeutic delivery, addressing infection, oxidative stress, hypoxia, and impaired tissue regeneration. Integration of herbal and polyherbal nanocarriers further expands options for cost-effective and natural adjunctive therapies. This review comprehensively evaluates the market landscape, current limitations, and future perspectives of DFU management, emphasising translational relevance. The convergence of biomaterials engineering, advanced drug delivery, and biosensing technologies holds transformative potential to improve healing outcomes, reduce healthcare costs, and advance personalised DFU care.

Keywords

DFU, novel drug delivery platform, new market trends, nanoparticles, herbal medicine.

Introduction

1.1 Prevalence and Incidence:

The global prevalence of diabetic foot ulcers (DFUs) is approximately 6.3%, with regional variability. For instance, studies have reported a prevalence of 13% in North America, 7.2% in Africa, and 5.1% in Europe (Zhang et al., 2017; Almobarak et al., 2017). The annual incidence of DFUs ranges from 1.0% to 4.1%, influenced by factors such as diabetes type, duration, and comorbidities (Singh et al., 2005).

1.2 Clinical Outcomes:

DFUs are associated with several adverse:

Figure 1 – Clinical Outcomes.

  • Slow Healing: Delayed wound healing is common due to factors like poor circulation, neuropathy, and impaired immune response (Ndosi et al., 2017).
  • Infection: Infections in DFUs can lead to complications such as osteomyelitis and sepsis, necessitating aggressive treatment (Matheson et al., 2021).
  • Amputation: Approximately 80% of all non-traumatic lower-limb amputations in diabetic individuals are preceded by foot ulcers (Boulton, 2015).
  • Recurrence: The recurrence rate of DFUs is notably high, with estimates suggesting that 60% of patients experience recurrence within 3 years after healing (Hsu et al., 2024).

1.3 Economic Burden:

The economic impact of DFUs is substantial, encompassing direct medical costs such as hospitalisation, surgical interventions, and long-term care, as well as indirect costs related to lost productivity and disability. In the United States, the estimated annual cost of treating a diabetic foot ulcer is approximately $28,000, with costs escalating if amputation is required (Singh et al., 2005). Globally, the financial burden is significant, with estimates indicating that the cost of DFUs can be over 5.4 times higher than for diabetic patients without them (Raghav et al., 2017).

2.0 LIMITATIONS OF EXISTING THERAPIES:

Despite advances in wound care, current therapies for diabetic foot ulcers (DFUs) face significant limitations that affect their efficacy and accessibility.

Figure 2 - Limitations of Existing Therapies

3. METHODOLOGY:

3.1 Diabetic Foot Ulcers (DFUs): Pathophysiology-

Diabetic foot ulcers are chronic, non-healing wounds that primarily result from peripheral neuropathy, peripheral arterial disease, and impaired immune response in diabetic patients (Zhao et al., 2025). Neuropathy leads to a loss of protective sensation, while vascular insufficiency reduces the oxygen and nutrient supply to tissues, thereby delaying healing (Guo et al., 2024). Additionally, hyperglycemia impairs collagen synthesis, angiogenesis, and fibroblast activity, thereby contributing to the formation of chronic wounds (Meng et al., 2025). DFUs are frequently colonised by polymicrobial communities, which increases the risk of infection and further complicates wound healing (Hosseini et al., 2024).

3.2 Conventional Treatments- Traditional DFU management includes:

Figure 3- Conventional Treatments- Traditional DFU management includes

Figure 4- Treatments for DFU

Although effective to some extent, these approaches often fail in chronic or complicated DFUs, with recurrence rates as high as 40% within one year (Chary et al., 2024). Limitations include poor localised drug delivery, inadequate tissue regeneration, and the inability to monitor the wound microenvironment.

3.3 Advanced Formulation Approaches-

To overcome these limitations, novel drug delivery and tissue engineering strategies have been developed:

Figure 5- Advanced Formulation Approaches.

  • Hydrogels: Hydrogels are hydrophilic polymer networks capable of absorbing large amounts of water while maintaining a moist environment that facilitates healing (Mallanagoudra et al., 2025). They can encapsulate bioactive molecules, growth factors, and antimicrobial agents, ensuring sustained and localised release (Yang et al., 2024).
  • Exosome-Based Therapy: Exosomes are nano-sized extracellular vesicles secreted by cells, rich in proteins, lipids, and nucleic acids. They promote angiogenesis, collagen deposition, and immune modulation, making them promising candidates for DFU therapy (Zhu et al., 2025; Guo et al., 2024).
  • Nanoparticles: Nanoparticles (metallic, lipid-based, polymeric) allow targeted drug delivery, controlled release, and antimicrobial action (Li et al., 2025). They enhance penetration into biofilms and protect labile drugs from degradation, improving efficacy in infected or chronic wounds (Hosseini et al., 2024).
  • Smart Dressings: Smart dressings integrate sensing and therapeutic functionalities, allowing real-time monitoring of pH, glucose, or infection markers and on-demand drug release (Zhao et al., 2025). This adaptive therapy reduces the risk of infection and accelerates healing.
  • Bioengineered Scaffolds: Bioengineered scaffolds (e.g., chitosan, silk fibroin) mimic the extracellular matrix to provide structural support, facilitate cell adhesion, proliferation, and angiogenesis, and can deliver stem cells or growth factors directly to the wound site (Abdollahi et al., 2024; Almasoudi et al., 2025).

3.4 Mechanism of Action of Advanced DFU Therapies-

3.4.1 Hydrogels:

Hydrogels act as three-dimensional polymeric networks capable of absorbing exudate while maintaining a moist wound environment, which is crucial for epithelialization and angiogenesis (Mallanagoudra et al., 2025).

  • Drug Delivery: Hydrogels can encapsulate antimicrobial agents, growth factors, or nanoparticles, providing sustained and localised release at the wound site (Yang et al., 2024).
  • Healing Facilitation: By maintaining hydration, they prevent desiccation, reduce scarring, and promote fibroblast proliferation, enhancing extracellular matrix formation.

Figure 6- DUF therapies – Hydrogels.

3.4.2 Exosome-Based Therapy:

Exosomes are cell-derived nano-vesicles (30–150 nm) that contain proteins, lipids, mRNA, and miRNA, which can modulate cellular signalling in the wound microenvironment (Guo et al., 2024).

  • Angiogenesis: Exosomal VEGF and miRNA cargo stimulate endothelial cell migration and capillary formation.
  • Collagen Deposition: Promotes fibroblast proliferation and extracellular matrix deposition, essential for tissue repair.
  • Immunomodulation: Modulate macrophage polarisation toward the pro-healing M2 phenotype, reducing chronic inflammation (Zhu et al., 2025).

Figure 7- DUF Therapies - Exosome-Based Therapy

3.4.3 Nanoparticles:

Nanoparticles serve as carriers for drugs or bioactive molecules, improving stability, bioavailability, and tissue penetration (Chary et al., 2024).

  • Antimicrobial Activity: Silver, zinc oxide, or other metal nanoparticles disrupt bacterial membranes, preventing biofilm formation.
  • Controlled Release: Polymeric nanoparticles release therapeutic agents in a sustained, site-specific manner, reducing systemic toxicity (Li et al., 2025).
  • Enhanced Cellular Uptake: Their nanoscale size facilitates endocytosis by keratinocytes and fibroblasts, accelerating wound closure.

Figure 7- DUF Therapies – Nanoparticles

3.4.4 Smart Dressings:

Smart dressings integrate biosensors, responsive hydrogels, or stimuli-sensitive polymers to actively monitor and respond to the wound environment (Zhao et al., 2025).

  • Real-Time Monitoring: Detect pH, glucose, or inflammatory markers, indicating infection or delayed healing.
  • On-Demand Drug Release: Release antibiotics, growth factors, or antioxidants in response to environmental triggers such as pH shifts or temperature changes.
  • Dynamic Therapy: Facilitates adaptive treatment, reducing chronicity and preventing complications.

Figure 8- DFU Therapies- Smart Dressings.

3.4.5 Bioengineered Scaffolds:

Bioengineered scaffolds mimic the extracellular matrix (ECM) and provide a structural and biochemical framework for tissue regeneration (Abdollahi et al., 2024).

  • Cellular Support: Promote adhesion, proliferation, and differentiation of keratinocytes, fibroblasts, and endothelial cells.
  • Growth Factor Delivery: Can be loaded with VEGF, PDGF, or other bioactive molecules for localised angiogenesis and tissue repair.
  • Stem Cell Incorporation: Supports mesenchymal stem cell (MSC) survival and paracrine signalling, enhancing wound closure and vascularisation (Almasoudi et al., 2025).

Figure 9- DUF Therapies - Bioengineered Scaffolds

4. Rationale for Next-Generation Formulations:

The limitations of existing diabetic foot ulcer (DFU) therapies underscore the urgent need for next-generation wound formulations that are multifunctional, responsive, and cost-effective. Current treatments, including conventional dressings, antimicrobial therapies, and growth factor products, often target single aspects of wound healing and fail to simultaneously address the complex pathophysiology of DFUs, which involves infection, impaired angiogenesis, chronic inflammation, and tissue degeneration (Armstrong et al., 2020; Ndosi et al., 2017).

Next-generation formulations aim to integrate multiple therapeutic functionalities within a single platform. For instance, advanced wound dressings can be engineered to:

  1. Control infection via sustained release of antimicrobial agents or incorporation of nanomaterials with antibacterial properties (Lipsky et al., 2020).
  2. Promote angiogenesis and tissue regeneration through delivery of growth factors, stem cells, or bioactive peptides that stimulate vascularisation and extracellular matrix formation (Boulton, 2015; Matheson et al., 2021).
  3. Respond to the wound environment by releasing therapeutics in response to pH, enzymatic activity, or oxidative stress, ensuring targeted and timely therapy (Everett & Mathioudakis, 2018).

Moreover, these innovative platforms provide a bridge between marketed systems and emerging delivery technologies, highlighting their translational potential. By integrating multifunctionality, environmental responsiveness, and scalability, these systems offer a clinically relevant approach to accelerate healing, reduce recurrence, minimise infection risk, and improve patient outcomes (Raghav et al., 2017).

Overall, the rationale for next-generation formulations is grounded in the need for therapeutic convergence: combining antimicrobial efficacy, regenerative stimulation, and wound responsiveness within cost-effective and clinically translatable platforms, thereby addressing the multidimensional challenges of DFU management.

Table1. Bridging Marketed DFU Therapies and Emerging Delivery Platforms

Category

Marketed/ Conventional Systems

Limitations

Emerging/ Next-Generation Platforms

Advantages/ Translational Potential

Dressings

Standard gauze, hydrocolloid, foam

Limited antimicrobial activity, low regenerative potential

Antimicrobial nanofiber dressings, hydrogel with bioactive molecules

Controlled drug release, infection control, moisture retention, tissue regeneration

Growth Factor Therapy

Recombinant PDGF gels, EGF creams

High cost, short half-life, single-function

Nanoparticle-encapsulated growth factors, dual/multi-factor delivery

Sustained release, enhanced angiogenesis and tissue repair

Skin Substitutes

Bioengineered skin (Apligraf®, Dermagraft®)

Storage issues, immunogenicity, and high cost

3D-printed skin scaffolds, stem cell-laden hydrogels

Personalised, multifunctional, responsive to wound microenvironment

Antimicrobial Therapy

Topical antibiotics, silver dressings

Resistance development, limited depth penetration

Metal/peptide nanoparticles, enzyme-responsive antimicrobial hydrogels

Targeted, controlled, broad-spectrum antimicrobial activity

Negative Pressure Therapy

VAC® systems

High cost, bulky, requires hospitalisation

Miniaturised, portable NPWT devices combined with drug delivery

Ambulatory use, localised healing enhancement, synergistic effect with active therapeutics

5. PATHOPHYSIOLOGY AND CHALLENGES IN DFU FORMULATION DESIGN-

5.1 Pathophysiological Barriers:

Diabetic foot ulcers (DFUs) present a complex microenvironment that significantly impairs wound healing. Key pathophysiological barriers include:

Figure 10 - Pathophysiological Barriers.

  1. Hypoxia: Peripheral vascular disease and impaired microcirculation lead to reduced oxygen supply, limiting cellular metabolism and angiogenesis (Brem & Tomic-Canic, 2007).
  2. Oxidative Stress: Excess reactive oxygen species (ROS) damage cellular components, inhibit fibroblast activity, and delay tissue repair (Falanga, 2005).
  3. Neuropathy: Sensory loss leads to unrecognised trauma, while autonomic neuropathy causes impaired sweat gland function and dry skin, increasing ulcer susceptibility (Armstrong et al., 2017).
  4. Ischemia: Macrovascular occlusions reduce perfusion, resulting in tissue necrosis and poor healing potential (Boulton, 2015).
  5. Biofilm-Associated Infection: Chronic DFUs are often colonised by polymicrobial biofilms, which protect bacteria from antibiotics and host immune responses, perpetuating inflammation and non-healing wounds (James et al., 2008).

5.2 Formulation Challenges-

Designing effective DFU formulations requires overcoming several critical challenges:

  • Poor Penetration Across Necrotic Tissue: Thick necrotic layers and slough impede drug diffusion and bioactive delivery to deeper wound beds (Everett & Mathioudakis, 2018).
  • Degradation of Bioactives: Growth factors, peptides, and other sensitive molecules are prone to enzymatic and oxidative degradation in the chronic wound environment (Matheson et al., 2021).
  • Lack of Sustained and Targeted Delivery: Conventional dressings fail to provide controlled release or site-specific delivery, reducing therapeutic efficacy and requiring frequent reapplication (Ndosi et al., 2017).
  • Patient Compliance and Application Issues: Frequent dressing changes, complex handling, and discomfort from existing wound care products reduce adherence, particularly in elderly or immobile patients (Singh et al., 2005).

Overcoming these challenges requires innovative delivery strategies, including nanocarrier systems, responsive hydrogels, and multifunctional scaffolds that can penetrate necrotic tissue, provide sustained release, and respond to the wound microenvironment.

6.0 CURRENT MARKETED FORMULATIONS AND DEVICES:

6.1 Conventional Wound Dressings:

Conventional dressings are the cornerstone of DFU management and include hydrocolloid, foam, alginate, and hydrogel-based systems (Thomas, 2008; Vowden & Vowden, 2017).

  • Mechanism: These dressings maintain a moist wound environment, absorb exudates, and provide mechanical protection. Hydrogels can also facilitate autolytic debridement.
  • Examples: Hydrocolloid dressings (Duoderm®), foam dressings (Allevyn®), alginate dressings (Kaltostat®), hydrogel dressings (Intrasite®).
  • Limitations: Limited antimicrobial action, lack of bioactive delivery, and minimal regenerative stimulation. Frequent dressing changes are often required, which can reduce patient compliance

6.2 Antimicrobial Formulations:

Antimicrobial dressings are used to prevent or control infection in DFUs. Common types include silver, iodine, and honey-based products (Lipsky et al., 2020; O’Meara et al., 2014).

  • Silver-based dressings: Release silver ions to kill bacteria; risk of cytotoxicity to keratinocytes and fibroblasts if overused.
  • Iodine-based dressings: Broad-spectrum antimicrobial activity but may impair thyroid function with prolonged use.
  • Honey-based products: Promote moist healing and possess antimicrobial activity; however, effects vary by honey type, and hyperglycemic patients require careful monitoring.
  • Limitations: Emergence of microbial resistance, cytotoxicity, and inconsistent clinical outcomes.

6.3 Growth Factor-Based Formulations:

Growth factors aim to stimulate angiogenesis and tissue repair (Falanga et al., 2006; Steed et al., 2006).

  • Becaplermin gel (PDGF): Shown to accelerate healing in chronic DFUs; requires daily application for weeks. Risk of malignancy with prolonged use is debated.
  • EGF-based sprays: Promote epithelialization; efficacy is limited by rapid degradation in the wound environment.
  • Limitations: High cost, short half-life, need for frequent administration, and variable clinical efficacy.

6.4 Bioengineered Skin Substitutes:

Bioengineered products provide living or acellular matrices to promote regeneration (Marston et al., 2003; Falanga et al., 2012).

  • Examples: Apligraf® (living bilayered skin), Dermagraft® (fibroblast-seeded dermal substitute), EpiFix® (amniotic membrane allograft).
  • Mechanism: Deliver viable cells, growth factors, and ECM components to support tissue repair.
  • Clinical efficacy: Shown to improve healing rates in chronic DFUs compared to standard care.
  • Limitations: High cost, storage under cold-chain conditions, limited reimbursement, and potential immunogenicity.

Table 2 – Type and Mechanism of DUF.

Type

Mechanism

Examples

Status

Key Limitation

Hydrocolloid Dressing

Moisture retention, autolytic debridement

Comfeel®, DuoDERM®

Marketed

Maceration, no antimicrobial action

Foam Dressing

Absorption,

cushioning

Allevyn®

Marketed

Frequent changes, limited bioactive delivery

Alginate Dressing

Exudate gel formation

Kaltostat®

Marketed

Poor antimicrobial activity

Hydrogel Dressing

Moisture retention, autolytic debridement

Intrasite Gel®

Marketed

Rapid dehydration

Silver Dressing

Antimicrobial

Acticoat®

Marketed

Cytotoxicity, resistance

Iodine Dressing

Antimicrobial

Iodosorb®

Marketed

Cytotoxicity, thyroid risk

Honey Dressing

Antimicrobial, anti-inflammatory

Medihoney®

Marketed

Variable potency

PDGF Gel

Stimulates granulation

Becaplermin

Marketed

High cost, malignancy risk

EGF Spray

Promotes epithelialization

-

Marketed

Short half-life, limited penetration

Apligraf®

Living cell therapy

Organogenesis

Marketed

Cost, storage, reimbursement

Dermagraft®

Fibroblast-derived dermal substitute

Organogenesis

Marketed

Cost, storage, availability

EpiFix®

Amniotic membrane graft

MiMedx

Marketed

Cost, limited access

6.5 Topical Oxygen Therapy and Negative Pressure Wound Devices:

  • Topical oxygen therapy: Enhances tissue oxygenation and promotes angiogenesis. Clinical adoption is limited due to equipment cost and variable evidence (Fife et al., 2012).
  • Negative pressure wound therapy (NPWT): Applies controlled suction to remove exudate, stimulate granulation tissue, and reduce oedema. Devices such as VAC® systems are widely used, though cost and bulkiness are limitations. Comparative trials suggest NPWT often outperforms standard dressings in healing rates but requires careful patient monitoring.

7.0 LIMITATIONS AND GAPS IN CURRENT MARKET PRODUCTS:

Despite significant advancements in diabetic foot ulcer (DFU) management, current market products exhibit several shortcomings that limit their clinical effectiveness and accessibility.

7.1 Limited Bioactivity and Targeted Therapy:

Most marketed wound dressings and topical formulations provide passive protection and moisture balance but lack active biological modulation of the wound microenvironment (Falanga, 2005; Brem & Tomic-Canic, 2007). For instance, hydrocolloid and foam dressings are primarily supportive, offering little stimulation for angiogenesis or re-epithelialization (Armstrong et al., 2020). Even bioactive formulations such as Becaplermin (PDGF) gel demonstrate only moderate healing rates, partly due to poor penetration into necrotic or ischemic tissues (Steed et al., 1995). There is also limited targeting capability toward infection sites, leading to uneven drug distribution and suboptimal efficacy (Lipsky et al., 2020).

7.2 Single-Function Focus:

Current therapies often focus on a single function, such as antimicrobial activity, without addressing other critical pathophysiological aspects like oxidative stress, ischemia, and impaired angiogenesis (Frykberg & Banks, 2015). Silver-based dressings, for example, are effective antimicrobials but do not promote tissue regeneration, and prolonged use may lead to cytotoxicity (Matheson et al., 2021). This one-dimensional approach fails to provide comprehensive wound healing, prolonging recovery and increasing recurrence rates (Singh et al., 2005).

7.3 Economic Barriers and Accessibility Issues:

The high cost of bioengineered skin substitutes and growth factor-based formulations significantly restricts their adoption, particularly in low- and middle-income countries (Marston et al., 2003; Raghav et al., 2017). Products like Apligraf® and Dermagraft® require specialised storage and handling, further increasing logistical and operational expenses. Consequently, most patients in resource-limited settings continue to rely on low-cost, non-bioactive dressings, resulting in persistent chronic wounds and higher amputation rates (Armstrong et al., 2020).

7.4 Lack of Personalised and Smart Feedback Systems:

Another critical gap lies in the absence of smart, patient-tailored systems that can monitor wound conditions (e.g., moisture, pH, infection markers) and respond dynamically (Lipsky et al., 2020; Frykberg & Banks, 2015). Smart dressings with real-time biosensing and controlled drug release remain largely in the research stage, with few commercial prototypes. Such technologies could significantly improve therapeutic precision and reduce hospital visits, particularly for diabetic patients with limited mobility (Raghav et al., 2017).

8. NEXT-GENERATION FORMULATION TECHNOLOGIES:

Advancements in drug delivery have significantly reshaped the landscape of diabetic foot ulcer (DFU) management. The primary goal of next-generation formulation systems is to provide multifunctional, targeted, and responsive therapies capable of addressing infection, oxidative stress, ischemia, and impaired tissue regeneration simultaneously (Frykberg & Banks, 2015; Falanga, 2005). The following subsections summarise emerging formulation platforms with promising translational potential.

8.1 Nanotechnology-Based Systems-

Nanotechnology enables controlled and site-specific delivery of therapeutic molecules through nanoscale carriers, enhancing penetration, bioavailability, and wound residence time.

Polymeric Nanoparticles: Polymeric nanoparticles made from PLGA, chitosan, and Eudragit® polymers have shown remarkable potential for sustained delivery of antimicrobials, antioxidants, and herbal extracts (Zhang et al., 2020). For instance, curcumin-loaded chitosan nanoparticles demonstrated accelerated wound contraction and collagen deposition in diabetic rats (Ponnanikajamideen et al., 2021).

Metal and Metal Oxide Nanoparticles: Nanoparticles such as silver (AgNPs), zinc oxide (ZnO), and copper oxide (CuO) exhibit      strong antimicrobial and angiogenic properties (Raguvaran et al., 2017). Silver nanoparticles disrupt bacterial biofilms, while ZnO nanoparticles stimulate fibroblast proliferation and wound closure (Lipsky et al., 2020).

Lipid Nanoparticles and Nano-emulsions:
Solid lipid nanoparticles (SLNs) and nanoemulsions improve transdermal drug transport and bioavailability (Basha et al., 2018). For example, silver-sulfadiazine-loaded SLNs demonstrated superior antibacterial efficacy and reduced cytotoxicity compared to conventional creams (Girish et al., 2020).

8.2 Hydrogel and Injectable Formulations:

Hydrogels offer a three-dimensional matrix mimicking extracellular tissue, providing a moist environment for healing.

Stimuli-Responsive Hydrogels: These “smart” materials release drugs in response to pH, ROS, or enzymatic activity within the wound. For instance, ROS-responsive chitosan hydrogels release antibiotics selectively at infection sites, minimising side effects (Liu et al., 2021).

Injectable Thermosensitive Hydrogels: Thermo-responsive hydrogels composed of chitosan, PEG, and gelatin transform into gels at body temperature, offering sustained drug release and ease of application (Zhao et al., 2020).

Oxygen-Releasing Hydrogels: Hydrogels incorporating calcium peroxide or hydrogen peroxide microspheres generate localised oxygen to correct hypoxia and stimulate angiogenesis, improving healing outcomes (Zhao et al., 2020).

8.3 Electrospun Nanofibrous Dressings:

Electrospun nanofibers replicate the extracellular matrix (ECM) architecture and support cell adhesion, migration, and nutrient transport.

Multilayered Nanofibers: Layered systems enable sequential drug release — for example, antimicrobials in the outer layer for infection control and growth factors in the inner layer for regeneration (Ravichandran et al., 2016).

Herbal and Peptide-Loaded Nanofibers: Curcumin, Aloe vera, and peptide (LL37)-loaded nanofibers have shown enhanced collagen formation, reduced inflammation, and faster wound re-epithelialization in diabetic models (Balaji et al., 2021).

Electrospun scaffolds can also integrate nanoparticles or exosomes for combined therapeutic effects, offering a biomimetic, tunable, and cost-effective approach (Lipsky et al., 2020).

8.4 Exosome and Cell-Free Biologics:

Exosomes are nano-vesicles secreted by cells, rich in proteins, cytokines, and microRNAs that modulate inflammation and promote tissue regeneration (Hu et al., 2021).

Stem Cell-Derived Exosomes: Mesenchymal stem cell (MSC)-derived exosomes accelerate angiogenesis and fibroblast migration without the risks associated with live-cell therapies (Li et al., 2020). Commercial candidates such as RION’s PEP™ and ADSC-exosomes have entered early clinical evaluation, showing reduced inflammation and improved granulation in DFUs (Hu et al., 2021).

Advantages: Exosome-based therapies are cell-free, low-immunogenic, and scalable for industrial production, representing a major leap toward regenerative, biologic-based DFU management.

8.5 Smart and Sensor-Integrated Dressings:

Smart wound dressings can detect microenvironmental changes and deliver therapy dynamically.

Sensing Capabilities: These dressings can respond to pH, temperature, glucose, and bacterial enzyme changes, enabling real-time wound assessment (Mostafalu et al., 2018).

Colour-Changing Indicators: Some hydrogels incorporate pH-sensitive dyes that visually indicate infection progression (Zhang et al., 2020).

Sensor-Integrated Platforms: Recent prototypes combine graphene or conductive polymer-based sensors that transmit wound data wirelessly to smartphones, aiding remote monitoring (Yadav et al., 2022). These systems align with the concept of personalised digital wound care and represent the future of diabetic ulcer management.

8.5 3D-Printed Scaffolds and Sprayable Systems:

3D printing enables the fabrication of personalised scaffolds tailored to wound size and depth.

Bioprinted Scaffolds: Incorporating growth factors (VEGF, PDGF) and nanoparticles allows controlled release and cellular support (Ng et al., 2020).

Table 3 - Formulation and Mechanisms.

Formulation Type

Representative Actives

Mechanism / Function

Advantages

Development Stage

Polymeric nanoparticles

Curcumin, Ag, EGF

Sustained, targeted release

Enhanced bioavailability

Preclinical

Metal/metal oxide NPs

ZnO, AgNPs

Antimicrobial, angiogenic

Dual-function healing

Preclinical

Stimuli-responsive hydrogel

Antibiotics, antioxidants

pH/ROS-triggered release

Site-specific action

Preclinical

Injectable thermogel

Growth factors, herbal extracts

Local sustained delivery

Non-invasive, prolonged effect

Preclinical

Electrospun nanofibers

Curcumin, LL37 peptide

ECM mimicry, sequential release

Regenerative and antimicrobial

Preclinical

Exosome therapy

MSC-exosomes

Anti-inflammatory, regenerative

Cell-free, low immunogenicity

Early clinical

Smart dressings

Sensors, antibiotics

pH/temp-responsive, feedback

Real-time monitoring

Prototype

3D-printed scaffold

VEGF, AgNPs

Structural support, controlled release

Personalized healing

Preclinical

Sprayable polymer

AgNPs, herbal actives

Rapid coverage, antimicrobial

Portable, flexible

Preclinical

Herbal nanocarriers

Aloe vera, Centella asiatica

Antioxidant, collagen synthesis

Cost-effective

Preclinical

Sprayable Polymeric Systems: These formulations offer rapid, uniform coverage for irregular wounds. For example, sprayable chitosan-silver composite systems provide antimicrobial protection and flexibility for ambulatory patients (Zhao et al., 2020).

8.6 Herbal and Polyherbal Nanocarriers (Novel Integration):

Phytochemical-based nanoformulations provide cost-effective alternatives for resource-limited settings. Curcumin, Aloe vera, and Centella asiatica-loaded nanoparticles exhibit strong antioxidant and anti-inflammatory activity, accelerating wound contraction and collagen synthesis (Ponnanikajamideen et al., 2021). Polyherbal nanoemulsions and hydrogels can combine multiple natural bioactives, offering synergistic and sustained healing effects (Ravichandran et al., 2016).

9.0 TRANSLATIONAL, REGULATORY, AND MANUFACTURING CHALLENGES:

9.1 Scale-up and reproducibility for biologics and exosomes

Large-scale production of exosomes and extracellular vesicles (EVs) remains a critical bottleneck. Yields from producer cells are typically low, and vesicle heterogeneity and process variability lead to inconsistent therapeutic performance (Ahn et al., 2022; Palakurthi et al., 2024). While ultracentrifugation and chromatography provide purity, they lack throughput for industrial scale. Bioreactor systems—such as hollow-fibre or stirred-tank reactors—improve productivity but require optimisation of shear stress and nutrient transfer to maintain exosome integrity (Lener et al., 2020). Harmonisation of critical quality attributes (CQAs)—including vesicle size, marker proteins (CD9, CD63, TSG101), RNA cargo, and potency assays—is essential for reproducibility and regulatory compliance (Gurunathan et al., 2021).

9.2 Sterility, stability, and quality assurance-

Exosome dressings must meet biologic-grade sterility and stability standards. Storage and transport conditions affect vesicle integrity; repeated freeze–thaw cycles or aggregation can impair function (Ahn et al., 2022). Lyophilisation and encapsulation in hydrogels or nanoparticles improve stability but require validated stability-indicating assays to confirm retention of potency (Brennan et al., 2023). Quality assurance therefore, integrates Good Manufacturing Practice (GMP) for aseptic processing, endotoxin testing, and real-time stability studies (FDA, 2024).

9.3 Combination product regulations (device + biologic)

Exosome-based wound dressings often qualify as “combination products,” requiring concurrent compliance with biologic and medical-device regulations. In the United States, oversight depends on the product’s primary mode of action under FDA’s Office of Combination Products (FDA, 2024). Manufacturers must align device-related testing (ISO 10993 biocompatibility, mechanical integrity) with biologic Chemistry-Manufacturing-Control (CMC) and sterility expectations (Riehemann et al., 2021). Early regulatory engagement facilitates efficient review and avoids jurisdictional delays.

9.4 Cost-effectiveness and reimbursement issues

Advanced biologic dressings typically cost more than conventional wound dressings, so payers demand clear evidence of clinical and economic benefit (Al-Gharibi, 2019). Health-economic analyses using cost-utility or budget-impact models are required to demonstrate value through faster healing, fewer complications, or reduced hospitalisations (Wounds International, 2025). Real-world outcome registries further support reimbursement dossiers.

9.5 Ethical considerations and clinical validation pathways

Ethical challenges include donor-cell sourcing, informed consent, and equitable access (Lener et al., 2020). Translational pathways should progress from robust preclinical validation to early human studies emphasising safety, immunogenicity, and biomarker endpoints, followed by adaptive phase II/III trials focused on time-to-closure and infection control (Palakurthi et al., 2024). Adaptive trial designs and biomarker-guided monitoring may shorten timelines while maintaining scientific rigour.

10.0 Market and Commercial Perspective-

  • 2024–2032 market projections:

The global wound-care market is forecast to rise from ≈ USD 21 billion in 2024 to ≈ USD 36 billion by 2032 (Fortune Business Insights, 2025). The advanced-wound-care segment alone is projected to grow at ≈ a 6–7 % CAGR, driven by chronic-wound prevalence and adoption of bioactive and smart dressings (SkyQuest Analytics, 2025).

  • Key commercial players-

Major corporations—including 3M (Health Care / Solventum), Smith & Nephew, Organogenesis, and ConvaTec—dominate the advanced wound-management sector through broad portfolios (hydrocolloids, collagen scaffolds, cellular skin substitutes) and extensive clinical-trial infrastructure (Smith & Nephew, 2024; Organogenesis, 2024; ConvaTec, 2024).

  • Start-ups focusing on exosome and nanotech platforms-

A growing number of start-ups are translating nanotechnology and exosome science into commercial wound-care applications. Examples include ExoLab Italia (plant-derived exosomes), Imbed Biosciences (nanomembrane dressings), NanoTess, and Cresilon—each leveraging unique nanomaterial or biologic systems (Labiotech, 2025). These innovators often partner with established med-tech companies for GMP manufacturing and distribution.

  • Cost–benefit comparison-

Marketed dressings offer proven safety and established reimbursement but limited biological activity. In contrast, exosome and nanotech platforms deliver antimicrobial, angiogenic, and regenerative functionality. If these systems achieve faster healing and reduced recurrence, they could yield long-term cost savings despite higher upfront prices (Al-Gharibi, 2019). However, confirmatory randomised controlled trials and formal HTA evaluations are essential to justify adoption.

11.0 Future Perspectives and Research Roadmap:

  • Multifunctional formulations: antimicrobial + angiogenic + antioxidant--

Future wound dressings will integrate multiple mechanisms—antimicrobial nanoparticles, pro-angiogenic exosomes, antioxidant phytochemicals—to create synergistic healing environments (Wisdom et al., 2024). Hybrid hydrogels and electrospun scaffolds already demonstrate dual infection control and tissue-regeneration potential in preclinical models.

  • Smart-responsive systems: on-demand drug release + biosensing-

Smart polymeric systems capable of sensing wound pH, reactive oxygen species, or bacterial enzymes and releasing drugs accordingly are advancing rapidly (Jain et al., 2023). Integration of biosensors and wireless modules could enable real-time wound monitoring and remote care.

  • Data-driven personalised wound care: integrating AI with smart dressings-

Machine-learning models analysing wound-image data can predict healing trajectories and optimise dressing changes (Wounds International, 2025). Embedding AI into sensor-based dressings supports adaptive, patient-specific therapy—an important step toward precision wound care.

  • Affordable production for global accessibility-

To achieve global reach, scalable and low-cost materials—such as roll-to-roll-processed hydrogels or herbal-loaded polymeric matrices—should be prioritised (Ahn et al., 2022). Continuous bioprocessing and single-use bioreactors can reduce cost while maintaining GMP standards, enabling deployment in low- and middle-income countries.

  • Clinical-translation focus-

A structured roadmap is recommended: (1) harmonise preclinical potency assays and CQAs; (2) perform adaptive phase I/II human studies with safety and biomarker endpoints; (3) launch platform trials comparing multiple formulations; and (4) establish post-market registries for long-term safety and cost-effectiveness (Palakurthi et al., 2024). Early dialogue with regulators and payers will facilitate smooth translation.

CONCLUSION:

Diabetic foot ulcer (DFU) management remains a complex clinical challenge due to the multifactorial pathophysiology, limited efficacy of conventional therapies, and economic barriers. This review highlights that bridging existing marketed formulations with next-generation delivery platforms is critical to enhance healing rates, improve patient outcomes, and reduce healthcare costs.

Emerging technologies including nanotechnology-based carriers, stimuli-responsive hydrogels, electrospun nanofibrous scaffolds, exosome therapies, smart sensor-integrated dressings, and 3D-printed personalised scaffolds offer multifunctional, targeted, and responsive strategies to overcome limitations of current treatments. The integration of biomaterials, advanced drug delivery, and biosensing technologies is particularly transformative, enabling real-time wound monitoring and site-specific therapy.

Ultimately, the successful translation of these innovative strategies into clinical practice will depend on synergistic collaboration among academia, industry, and regulatory agencies, combined with rigorous preclinical and clinical evaluation. Such integrated efforts promise to redefine DFU care, shifting from reactive management toward precision, personalised, and cost-effective wound healing solutions.

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Devina Gaike
Corresponding author

Yash Institute of Pharmacy. Chhatrapati Sambhajinagar

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Rutuja Sahajrao
Co-author

Yash Institute of Pharmacy. Chhatrapati Sambhajinagar

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Ajay Rore
Co-author

Yash Institute of Pharmacy. Chhatrapati Sambhajinagar

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Dr. S. S. Angadi
Co-author

Yash Institute of Pharmacy. Chhatrapati Sambhajinagar

Rutuja Sahajrao, Devina Gaike, Ajay Rore, Dr. S. S. Angadi, Advanced Formulation Strategies for Diabetic Foot Ulcers: Bridging Current Market Therapies with Future Drug Delivery Platforms, Int. J. of Pharm. Sci., 2025, Vol 3, Issue 11, 1839-1860. https://doi.org/10.5281/zenodo.17590071

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