What drugs are FDA approved for diabetic foot ulcers?: A Comprehensive Guide

October 12, 2025 •

4 min read

Approximately 15% of patients with diabetes will develop a diabetic foot ulcer, and finding effective treatments is crucial to prevent serious complications. A key part of treating these challenging wounds involves FDA-approved interventions that aid in healing and managing infection. So, what drugs are FDA approved for diabetic foot ulcers?

Quick Summary

A guide detailing the FDA-approved medications and biologic products for treating diabetic foot ulcers, exploring topical treatments, advanced skin substitutes, and the role of antibiotics in managing associated infections.

Key Points

Regranex (Becaplermin): A topical gel approved for neuropathic diabetic ulcers to stimulate wound healing by promoting granulation tissue growth.
Santyl (Collagenase) Ointment: An enzymatic debriding agent that selectively removes necrotic tissue to prepare the wound bed for healing.
Biologic Skin Substitutes: Products like Apligraf, Dermagraft, and Omnigraft provide biological scaffolds or living cells to promote skin and tissue regeneration in chronic ulcers.
Antibiotics for Infection: A range of FDA-approved oral and intravenous antibiotics, such as linezolid and piperacillin-tazobactam, are used to treat infections, a common complication of DFUs.
Comprehensive Care is Crucial: Effective treatment relies on a combination of these products with standard care, including offloading, debridement, and managing blood glucose.

The Foundation of Diabetic Foot Ulcer Treatment

Diabetic foot ulcers (DFUs) are a significant complication of diabetes, often resulting from a combination of peripheral neuropathy, peripheral artery disease, and impaired immune function. The foundation of effective DFU management includes proper glycemic control, offloading pressure from the wound, regular debridement of dead tissue, and addressing any underlying infections. Specialized medications and wound care products approved by the U.S. Food and Drug Administration (FDA) play a critical role in supplementing this standard care to promote healing.

FDA-Approved Prescription Treatments

Topical Growth Factor Therapy: Regranex (Becaplermin)

Regranex is an FDA-approved topical gel containing becaplermin, a recombinant human platelet-derived growth factor (PDGF). It is approved for diabetic neuropathic ulcers with adequate blood supply that extend into or beyond the subcutaneous tissue. Becaplermin promotes wound repair by stimulating cells involved in healing and enhancing granulation tissue formation. Regranex is applied daily to a cleaned wound and rinsed off after 12 hours. A black box warning exists due to an increased risk of cancer mortality with extensive use, and it should not be used on wounds with necrotic tissue or malignancy.

Enzymatic Debridement Agent: Santyl (Collagenase) Ointment

Santyl is the only FDA-approved enzymatic debriding agent for chronic dermal ulcers, including DFUs. It contains collagenase, an enzyme from Clostridium histolyticum, that specifically breaks down collagen in necrotic tissue without harming healthy tissue. By removing dead tissue, Santyl prepares the wound bed for healing and may stimulate tissue repair. It is applied topically to the wound, often under a sterile dressing.

Biologic Skin Substitutes and Dermal Matrices

For complex or non-healing ulcers, the FDA has approved biologic products, considered medical devices, to aid tissue regeneration.

Apligraf (Graftskin)

Apligraf is a living bilayered skin substitute with human keratinocytes and fibroblasts in a bovine collagen matrix. It is indicated for non-healing DFUs that haven't responded to standard care for four to eight weeks. Apligraf provides living cells and proteins to promote healing and is applied by a healthcare provider after debridement, used with standard wound care. It is not for infected wounds or patients allergic to bovine collagen.

Dermagraft

Dermagraft is a human fibroblast-derived dermal substitute using fibroblasts and extracellular matrix on a bioabsorbable mesh. It is for full-thickness DFUs lasting over six weeks without tendon or bone exposure. Dermagraft provides a scaffold to recruit cells and growth factors for healing. Like Apligraf, it is used with standard care and not on infected wounds.

Omnigraft Dermal Regeneration Matrix

Omnigraft, approved in 2016, is a dermal regeneration matrix from silicone, bovine collagen, and shark cartilage. It acts as a scaffold to support the growth of new skin tissue and blood vessels. It is approved for partial- and full-thickness neuropathic DFUs over six weeks, provided there is no bone, tendon, or capsule exposure. A study showed Omnigraft with standard care resulted in complete wound closure in 51% of patients after 16 weeks, compared to 32% with standard care alone.

Antibiotics for Associated Infections

Antibiotics are essential FDA-approved medications for treating infections complicating DFUs, though they don't heal the ulcer directly. The choice depends on infection severity and bacteria type. Mild to moderate infections may use oral antibiotics like amoxicillin-clavulanate. Moderate to severe infections typically require IV antibiotics, such as piperacillin-tazobactam or ertapenem. For suspected or confirmed MRSA, antibiotics like linezolid or vancomycin are used.

Comparison of Key FDA-Approved Treatments for DFUs


Treatment	Type	Mechanism of Action	Application Method	Typical Indication
Regranex (Becaplermin)	Topical Gel	Recombinant PDGF promotes granulation tissue formation.	Once-daily topical application.	Neuropathic ulcers with adequate blood flow.
Santyl (Collagenase)	Ointment	Enzymatic debridement of necrotic tissue.	Topical application.	Chronic dermal ulcers with necrotic tissue.
Apligraf	Bilayered Skin Substitute	Provides living cells and collagen to stimulate healing.	Applied topically by clinician.	Non-healing DFUs after standard therapy.
Dermagraft	Dermal Substitute	Fibroblast-derived matrix promotes tissue regeneration.	Applied topically by clinician.	Full-thickness DFUs over 6 weeks, no bone exposure.
Omnigraft	Dermal Regeneration Matrix	Scaffold of collagen and cartilage for tissue growth.	Applied topically by clinician.	Partial/full-thickness DFUs >6 weeks, no bone exposure.
Antibiotics	Oral/Intravenous	Eliminate bacterial infections complicating ulcers.	Varies based on infection severity.	Infected DFUs.

The Role of Comprehensive Care

FDA-approved products are part of a broader treatment strategy, not a standalone solution. Fundamental care practices are crucial for optimal outcomes.

Offloading: Reducing pressure on the ulcer is essential for healing, using special footwear, casts, or crutches.
Blood Glucose Control: Stable blood sugar is fundamental for proper healing.
Debridement: Regular professional removal of dead tissue promotes healthy growth.
Infection Management: Appropriate antibiotic therapy is vital for infected ulcers to prevent spread.

Conclusion

Several FDA-approved medications and biologic products are available to aid diabetic foot ulcer healing, including the growth factor gel Regranex, the enzymatic ointment Santyl, and skin substitutes like Apligraf, Dermagraft, and Omnigraft. FDA-approved antibiotics treat complicating infections. Success depends on these treatments being part of comprehensive care, including proper wound management, offloading, and glycemic control. Patients should consult their healthcare team for personalized treatment plans.

Visit the FDA website for more information on approved medical products

Frequently Asked Questions

Regranex is a prescription topical gel containing recombinant human platelet-derived growth factor. It is used to promote the healing of neuropathic diabetic foot ulcers that have adequate blood supply, by stimulating the growth of new tissue.

Santyl is an ointment containing collagenase, an enzyme that specifically breaks down and removes necrotic (dead) tissue from a wound. This process, called enzymatic debridement, helps prepare the wound for healing.

No, Apligraf and Dermagraft are considered advanced biologic medical devices, not traditional drugs. They contain living or biological materials that are applied to the wound to help promote healing by regenerating tissue.

Antibiotics are used when a diabetic foot ulcer becomes infected with bacteria. The specific antibiotic and treatment duration depend on the severity of the infection and the type of bacteria identified.

Yes, offloading, or reducing pressure on the ulcerated area, is a critical part of treatment. It prevents further damage and allows the wound bed to heal without repeated injury from walking or standing.

Yes, the FDA has issued a black box warning for Regranex due to an increased risk of cancer mortality in patients who have used three or more large tubes of the gel. It is contraindicated in patients with known skin cancers at the application site.

Omnigraft is a dermal regeneration matrix that provides a scaffold made of collagen and cartilage. When placed on an ulcer, it facilitates the growth of new skin and blood vessels, leading to wound closure.