Becaplermin

Summary

Becaplermin is a topical gel containing recombinant human platelet‑derived growth factor‑BB (rhPDGF‑BB). It is approved for the treatment of neuropathic diabetic foot ulcers and has been used off‑label for ulcerated infantile hemangiomas. The gel is applied to the wound in conjunction with standard ulcer care, aiming to accelerate healing and reduce complications such as amputation.

Mechanism of Action

Becaplermin delivers PDGF‑BB, a dimeric growth factor that binds PDGF receptors (α and β isoforms) on fibroblasts, smooth‑muscle cells and endothelial cells. Receptor activation triggers intracellular signaling cascades (e.g., PI3K/Akt, MAPK) that promote chemotaxis, proliferation, extracellular‑matrix production and angiogenesis, processes essential for wound repair and granulation‑tissue formation.

What the Research Shows

Four multicenter, randomized, placebo‑controlled trials involving 922 patients examined becaplermin gel (30 µg/g or 100 µg/g) added to good ulcer care. Two trials showed significantly higher complete‑healing rates versus placebo, a third suggested a two‑fold increase (not powered for statistical analysis), and a fourth found no difference. Safety analyses across six controlled studies (538 becaplermin‑treated patients) reported adverse‑event rates comparable to placebo or standard care, with mild erythematous rash in ~2% of treated wounds and no neutralising antibodies. A Markov model of European health systems projected an average gain of 0.81 ulcer‑free months per patient and a 9% lower amputation risk, with cost‑saving potential in several countries. Expert reviews cite becaplermin as an advanced option for hard‑to‑heal diabetic foot ulcers, though they stress the need for larger trials and note limited uptake due to expense. A retrospective pediatric series reported its use as part of combination therapy for ulcerated hemangiomas.

Reported Benefits

Clinical trials have demonstrated that becaplermin can increase the proportion of diabetic foot ulcers achieving complete closure compared with placebo when used with good wound care. Economic modeling suggests it may extend ulcer‑free time and lower amputation risk, achieving cost‑saving or modest cost‑effectiveness in some European settings. Safety data show a similar adverse‑event profile to standard care, with only mild skin rash observed in a small minority.

Limitations of the Evidence

Efficacy results are inconsistent; one trial found no benefit over standard care. The drug is expensive, limiting accessibility, especially in low‑resource settings. Evidence is confined mainly to diabetic foot ulcers, with only anecdotal reports for ulcerated hemangiomas. Long‑term outcomes and comparative effectiveness versus newer agents remain unclear, and larger, high‑quality RCTs are still needed to define its role in routine practice.

Safety Considerations

Across six controlled studies, becaplermin gel showed a safety profile comparable to placebo and good ulcer care. Ulcer‑related complications (infection, cellulitis, osteomyelitis) occurred at similar rates. A mild erythematous rash was reported in about 2% of treated patients, versus 1% with placebo, and no rash was seen with ulcer care alone. Systemic adverse events, mortality and the development of neutralising antibodies were not increased, indicating overall tolerability when applied topically.

How It Is Administered

Becaplermin is supplied as a topical gel (30 µg/g or 100 µg/g) applied directly to the ulcer surface, typically once daily, in conjunction with standardized good wound care practices such as debridement, off‑loading and infection control. The formulation is intended for external use only and is stored according to manufacturer recommendations.

Routes of Administration

Goals & Uses

• Diabetic foot ulcer healingWound HealingHigh
• Granulation tissue formationTissue RepairHigh
• Chronic wound managementWound HealingModerate
• Accelerate diabetic foot ulcer closureWound HealingHigh

Contraindications

• Active malignancyOncologyHighUse caution or avoid depending on agent and context
• Hypersensitivity to becaplermin or parabensAllergic/immunologicHigh
• Neoplasm at application siteOncologicHigh
• Application near wounds with inadequate blood supplyVascularModerate
• Known hypersensitivity to becaplermin or any gel componentAllergyModerate

Adverse Effects

• Skin irritationDermatologicCommon
• Potential increased risk of malignancySystemic RiskRare
• Application site erythemaLocalCommon
• Pain at application siteLocal Skin ReactionCommon
• Local erythemaDermatologicCommon
• Increased cancer mortality riskOncologicRare
• Infection at wound siteInfectiousUncommon

Drug Interactions

• Topical antiseptics (e.g., povidone-iodine, hydrogen peroxide)Moderate
• Systemic immunosuppressants (e.g., corticosteroids)Moderate

Population Constraints

• Pediatric patientsAgeRelative
• Patients < 18 yearsAgeRelative
• Pregnant womenReproductiveRelative
• Patients with diabetic foot ulcersIndicationAbsolute
• Patients with History of MalignancyOncologyRelative

Regulatory Status

• European UnionUnapprovedNot authorized in the European Union.
• United StatesApprovedApproved: Diabetic foot ulcer (non‑healing)Approved under NDA 021917; marketed as Regranex.
• United KingdomUnapprovedNo marketing authorization; may be accessed via compassionate use.

FDA‑approved (Regranex) for diabetic foot ulcer healing; contraindicated in patients with active malignancy or known hypersensitivity; boxed warning for potential increased risk of cancer with prolonged use.

Evidence & Sources

• Cost effectiveness of Becaplermin in the treatment of diabetic foot ulcers in four European countries
  Journal ArticleHighGhatnekar O, et al.2001-01-01T00:00:00.000000Z
• Advancing pharmacotherapy for diabetic foot ulcers
  Journal ArticleModerateEleftheriadou I, et al.2019-01-01T00:00:00.000000Z
• Clinical efficacy of becaplermin (rhPDGF-BB) gel. Becaplermin Gel Studies Group
  Journal ArticleModerateWieman TJ1998-01-01T00:00:00.000000Z
• Clinical safety of becaplermin (rhPDGF-BB) gel. Becaplermin Studies Group
  Journal ArticleModerateSmiell JM1998-01-01T00:00:00.000000Z
• Therapy of ulcerated hemangiomas
  Journal ArticleModerateMcCuaig CC, et al.2013-01-01T00:00:00.000000Z
• Becaplermin gel in the treatment of diabetic neuropathic foot ulcers
  Journal ArticleModeratePapanas N, Maltezos E2008-01-01T00:00:00.000000Z

Frequently Asked Questions