Diabetic Foot Ulcers - Pipeline Insight, 2025

DelveInsight's, "Diabetic Foot Ulcers - Pipeline Insight, 2025" report provides comprehensive insights about 20+ companies and 25+ pipeline drugs in Diabetic Foot Ulcers pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered:

• Global coverage

Diabetic Foot Ulcers: Understanding

Diabetic Foot Ulcers: Overview

Diabetic foot ulcers (DFUs) are a common and serious complication of diabetes, often leading to hospitalization and amputation. They are characterized by skin lesions that can extend into deeper tissues, sometimes involving bone and muscle. The lifetime risk of developing a DFU for individuals with diabetes is estimated at 34%. DFUs not only cause significant suffering but also result in substantial healthcare costs, with the treatment of DFUs and lower extremity amputations costing billions annually. The high mortality rate associated with DFUs, especially in patients with concomitant kidney disease or those on dialysis, underscores the urgent need for preventive strategies. Effective foot care for high-risk patients can significantly reduce complications, highlighting the importance of early intervention and regular monitoring.

The pathway to diabetic foot ulceration is complex, involving the interaction of multiple risk factors. In a study, 63% of foot ulcers resulted from a combination of neuropathy, deformity, and trauma, with ill-fitting footwear being the most common cause of trauma in Western countries. Neuropathy often leads to reduced sensory input, causing individuals to wear shoes that may be too tight, increasing pressure and the risk of ulceration. Common risk factor combinations include neuropathy and mechanical trauma (e.g., a foreign body in the shoe), thermal trauma (e.g., burns from hot surfaces), and chemical trauma (e.g., improper use of over-the-counter treatments). Neuropathy remains the leading risk factor for new ulcers, but the rising prevalence of neuro-ischemic ulcers-resulting from both neuropathy and poor circulation-has become more common in recent years.

The clinical evaluation of a Diabetic Foot Ulcer involves assessing the site, size, depth, and the vascular and neuropathic status of the wound. Neuropathic ulcers typically occur in warm, insensate feet, often under pressure areas, and are surrounded by callus, while ischemic wounds are usually found in cool, poorly perfused feet, with no callus present. In neuro-ischemic wounds, the appearance depends on the dominance of either neuropathy or ischemia. Accurate identification of ischemia is crucial, with non-invasive Doppler ultrasound studies recommended for cool feet with impalpable pulses. When diagnosing infection, clinical evaluation is key, but tissue specimens should be cultured for sensitivity testing. Osteomyelitis, commonly present in diabetic foot ulcers, can be diagnosed using the "probe to bone" test, and radiographic imaging, especially plain X-rays, remains the first step in diagnosis, though more advanced imaging may be necessary for definitive assessment. Regular and high-quality radiographic studies, along with clinical context, are essential in diagnosing osteomyelitis and guiding treatment decisions.

The management of Diabetic Foot Ulcers (DFUs) involves several key principles, guided by the University of Texas Wound Classification System. For neuropathic plantar ulcers, the primary treatment includes sharp debridement of the ulcer and surrounding callus, followed by offloading pressure from the affected area using devices such as casts, boots, or felted foam dressings. The total contact cast (TCC) is considered the gold standard for offloading, and healing typically occurs within three months for uncomplicated cases. Neuro-ischemic ulcers, which involve both neuropathy and impaired arterial flow, require vascular assessment and may necessitate revascularization, along with appropriate antibiotic treatment for infections. For infected ulcers, debridement, offloading, and targeted antibiotics are essential, with antibiotics adjusted based on culture results. Osteomyelitis, often present in DFUs, may be managed with antibiotics alone for localized cases, but surgery is still common for more extensive infections. Adjunctive treatments like sucrose octasulfate dressings, hyperbaric oxygen therapy, and negative pressure wound therapy (NPWT) are considered for complex, non-healing wounds. Recent guidelines from the American Diabetes Association and the International Working Group on the Diabetic Foot highlight these treatments, with support for evidence-based therapies such as NPWT and bioengineered skin substitutes.

"Diabetic Foot Ulcers- Pipeline Insight, 2025" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Diabetic Foot Ulcers pipeline landscape is provided which includes the disease overview and Diabetic Foot Ulcers treatment guidelines. The assessment part of the report embraces, in depth Diabetic Foot Ulcers commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Diabetic Foot Ulcers collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights:

• The companies and academics are working to assess challenges and seek opportunities that could influence Diabetic Foot Ulcers R&D. The therapies under development are focused on novel approaches to treat/improve Diabetic Foot Ulcers.

Diabetic Foot Ulcers Emerging Drugs Chapters

This segment of the Diabetic Foot Ulcers report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III, II, I, Preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Diabetic Foot Ulcers Emerging Drugs

• ENERGI-F703 GEL: Energenesis Biomedical Co., Ltd.

ENERGI-F703 is a gel for external use accelerating healing of diabetes-caused wounds, mainly by activating AMPK inside cells to boost the density of ATP, energy molecules, in tissues near the wounds. Cellular and animal tests show that the application of ENERGI-F703 can produce the various effects. It can reduce the inflammation of endothelial cells of blood vessels. It can accelerate the fibrosis of fibroblasts in the skin of wounds and increasing the deposition of collagen and the formation of granulation tissues. It can also speed up the healing of wounds by promoting the migration of epithelia cells in the skin of wounds. Via the utilization of diabetic model mouse, it's proven that the application of ENERGI-F703 gel on wounds can accelerate healing of wounds. Currently, the drug is in Phase III stage of its development for the treatment of Diabetic Foot Ulcers.

• Topical Pravibismane: Microbion Corporation

Topically administered pravibismane, comprised of a suspension of pravibismane in a hydrogel formulation (MBN-101), has the potential to provide important advantages for the treatment of DFIs, including the dual broad-spectrum antimicrobial and anti-biofilm effects of the drug and its ability to kill common antibiotic resistant species. Standard of care is frequently ineffective in treating these patients. Ineffective management of DFIs has the potential to result in lower limb amputations; high treatment costs; additional hospitalizations; and the need for long courses of systemic antibiotics. Additionally, Qualified Infectious Disease Product (QIDP) designation and Fast Track status have been also granted for topical pravibismane (MBN-101) by the US FDA for adjunctive treatment of moderate and severe diabetic foot ulcer infections. Currently, the drug is in Phase II stage of its development for the treatment of Diabetic Foot Ulcers.

• PEP (Purified Exosome Product): Rion Inc.

RION's Purified Exosome Product(TM) (PEP(TM)) is a shelf stable product in a lyophilized powder derived from human platelets that contains stabilized platelet-derived regenerative exosomes. PEP(TM) is an exosome therapeutic that is designed to promote cell growth and formation of new blood vessels, while also reducing inflammation and protecting cells. Exosomes are nanoscale extracellular vesicles, secreted by cells that act as carriers of biological messages. These messages, composed of proteins, nucleic acids, and lipids, are transported from their cell of origin to other cells, orchestrating a multitude of processes that underpin health, disease, and the regenerative capabilities of the body. RION harnesses the unique regenerative properties of platelets, an ideal source of regenerative exosomes, due to their natural role in healing and regeneration. Currently, the drug is in Phase II stage of its development for the treatment of Diabetic Foot Ulcers.

• AUP1602-C: Aurealis Oy

AUP-16 is a genetically engineered Lactococcus Cremoris, a non-pathogenic, probiotic bacteria, expressing human basic fibroblast growth factor (FGF-2, bFGF), interleukin-4 (IL-4) and macrophage colony stimulating factor (CSF-1, mCSF), an all in one product and accepted as one active pharmaceutical ingredient from regulatory perspective. AUP-16 is topically applied on chronic wounds and covered by wound dressing like in diabetic foot ulcers, venous leg ulcers or other ulcer types. In the wound AUP-16 acts as millions of bioreactors producing the therapeutic proteins, which are designed to halt chronic inflammation in the wound, induce growth of new blood vessels, and promote granulation tissue formation and skin re-epithelization, all in one product. Currently, the drug is in Phase II stage of its development for the treatment of Diabetic Foot Ulcers.

Diabetic Foot Ulcers: Therapeutic Assessment

This segment of the report provides insights about the different Diabetic Foot Ulcers drugs segregated based on following parameters that define the scope of the report, such as:

• Major Players in Diabetic Foot Ulcers
• There are approx. 20+ key companies which are developing the therapies for Diabetic Foot Ulcers. The companies which have their Diabetic Foot Ulcers drug candidates in the most advanced stage, i.e. Phase II include, Energenesis Biomedical Co., Ltd.
• Phases

DelveInsight's report covers around 25+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
• Route of Administration

Diabetic Foot Ulcers pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical
• Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy
• Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Diabetic Foot Ulcers: Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses Diabetic Foot Ulcers therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Diabetic Foot Ulcers drugs.

Diabetic Foot Ulcers Report Insights

• Diabetic Foot Ulcers Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Diabetic Foot Ulcers Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions:

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Diabetic Foot Ulcers drugs?
• How many Diabetic Foot Ulcers drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Diabetic Foot Ulcers?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Diabetic Foot Ulcers therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Diabetic Foot Ulcers and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Energenesis Biomedical Co., Ltd
• Microbion Corporation
• Rion Inc.
• Aurealis Oy
• BioTissue Holdings, Inc
• Technophage, SA
• Biocomposites Ltd
• PolarityTE
• NOxy Health Products, LLC
• Cytora Ltd.
• Jiangsu ProteLight Pharmaceutical & Biotechnology Co., Ltd.
• Anterogen Co., Ltd.
• Cell2Cure ApS
• Lakewood-Amedex Inc
• FibroBiologics

Key Products

• ENERGI-F703 GEL
• Topical Pravibismane
• PEP (Purified Exosome Product)
• AUP1602-C
• TTAX01
• TP-102
• STIMULAN VG
• SkinTE
• NOX1416
• hOMSC200
• Antimicrobial Peptide PL-5 Topical Spray
• ALLO-ASC-DFU
• Cell2Cure
• Nu-3 gel
• CYW 628