Should plermin gel (becaplermin) be used as the first line of treatment for diabetic foot ulcers?

Management of Diabetic Foot Ulcers: Role of Becaplermin Gel

Becaplermin gel (PDGF-BB) should not be used as first-line treatment for diabetic foot ulcers. Instead, standard of care interventions should be implemented first, with becaplermin considered only after standard care has failed 1.

First-Line Management of Diabetic Foot Ulcers

The principles of care for diabetic foot ulcers should follow this algorithm:

1. Standard of Care (First Line):

   • Treatment of any associated infection
   • Revascularization if appropriate
   • Offloading to minimize trauma to the ulcer site
   • Regular wound cleaning with water or saline
   • Appropriate dressing selection based on wound characteristics
   • Regular sharp debridement as needed 1

2. Offloading Strategies:

   • For plantar ulcers: Non-removable knee-high devices (total contact cast) when possible
   • For non-plantar ulcers: Removable walkers or appropriate footwear modifications 2

3. Wound Dressing Selection:

   • Select based on wound characteristics, exudate level, and cost
   • Use sterile, inert protective dressings to maintain moist wound environment 1

When to Consider Becaplermin Gel

Becaplermin gel (recombinant platelet-derived growth factor-BB) should only be considered as an adjunctive therapy when:

• Standard of care has been properly implemented for at least 2-4 weeks
• The ulcer shows poor healing response despite good perfusion
• The patient has no active infection 1, 3

Evidence on Becaplermin Effectiveness

The evidence regarding becaplermin's effectiveness is mixed:

• The 2012 IWGDF guidelines state that "the effectiveness of topical platelet-derived growth factor (becaplermin) remains to be confirmed" 1
• The 2020 IWGDF guidelines note that although some studies suggest benefit, the evidence is inconclusive, and cost-effectiveness has not been established 1
• Older research studies showed that becaplermin gel increased complete healing compared to placebo (50% vs 36%) and decreased time to healing 4, 5

Important Considerations and Limitations

• Cost concerns: Becaplermin is expensive, and cost-effectiveness studies are lacking 1
• Limited application: Should be tried for a 2-week period and objectively assessed before continuing therapy 3
• Patient selection: Most appropriate for patients with smaller ulcers (≤5 cm²) with adequate perfusion 4
• Compliance: Treatment efficacy is significantly associated with drug and dressing compliance 5

Alternative Adjunctive Therapies to Consider

If standard care fails, other adjunctive therapies with more recent evidence might be considered before becaplermin:

• Autologous leucocyte, platelet, and fibrin patch (conditional recommendation with moderate evidence) 1
• Hyperbaric oxygen therapy for neuro-ischemic or ischemic ulcers 2
• Topical oxygen therapy as an adjunct to standard care 2

Conclusion

Standard of care interventions (offloading, debridement, appropriate dressings, infection control) should be optimized before considering becaplermin gel. When standard care fails, becaplermin may be considered as an adjunctive therapy, but its effectiveness remains uncertain according to recent guidelines, and other adjunctive therapies may be preferable based on more recent evidence.