How to reduce diabetic foot ulcer wounds with Regen-D (Becaplermin) ointment?

Diabetic Foot Ulcer Treatment with Regen-D (Becaplermin) Ointment

Apply becaplermin gel 0.01% (100 mcg/g) once daily as an adjunct to comprehensive wound care, which significantly increases complete healing rates by 39% compared to standard care alone and reduces healing time by 30%. 1

Application Protocol

Becaplermin must be used in conjunction with specific wound care practices to achieve optimal outcomes:

• Perform complete sharp debridement of necrotic tissue and debris before initiating treatment 2
• Apply becaplermin gel 0.01% (100 mcg/g formulation) once daily to the ulcer surface 1
• Maintain a moist wound environment throughout treatment 2
• Ensure complete offloading and optimal weight displacement from the affected area 2
• Control any infection before or during treatment 2

Expected Clinical Outcomes

The evidence demonstrates substantial clinical benefit when becaplermin is properly utilized:

• Complete healing occurs in 50% of patients treated with becaplermin plus good wound care versus only 36% with standard care alone (p=0.007) 1
• Median time to complete healing is reduced from 20.1 weeks to 14.1 weeks—a 30% reduction 1
• Predicted complete wound closure occurs by 27 weeks with becaplermin versus 88% closure at 52 weeks without it 3

These results are based on a combined analysis of 922 patients with chronic, full-thickness lower extremity diabetic ulcers of at least 8 weeks' duration 1

Patient Selection Criteria

Becaplermin is most effective in patients meeting specific criteria:

• Full-thickness diabetic foot ulcers that have failed to heal despite appropriate therapy 4
• Adequate lower extremity vasculature (critical requirement) 4
• Infection-free ulcers at treatment initiation 4
• Ulcers ≤10 cm² show best response, with median ulcer area of 1.5 cm² in successful trials 1

Treatment Duration and Monitoring

Implement a structured approach to treatment duration:

• Continue becaplermin for up to 20 weeks if showing response 4
• Discontinue treatment at 10 weeks if the ulcer shows no response to avoid unnecessary cost and optimize resource utilization 4
• Monitor wound surface area reduction as a predictor of complete closure 3

Safety Profile

Becaplermin demonstrates excellent tolerability:

• Adverse events are similar in nature and incidence to placebo groups 1
• The medication is safe and easy to use with once-daily application 2
• No unexpected adverse events occurred during treatment or 3-month follow-up periods 1

Cost-Effectiveness Considerations

Becaplermin provides economic value despite higher medication costs:

• Total 1-year direct cost of care is lower with becaplermin ($4,414) versus standard care alone ($6,809) 3
• Cost per cm² of wound closure is reduced from $3,501 to $2,006 3
• Incremental cost-effectiveness ratio is $6 per ulcer-day averted, resulting in 26 fewer ulcer-days per patient per year 4

Mechanism of Action

Becaplermin is recombinant human platelet-derived growth factor-BB (PDGF-BB):

• Produced through insertion of the PDGF B-chain gene into Saccharomyces cerevisiae yeast 2
• Promotes chemotactic recruitment and proliferation of cells involved in wound repair 2
• Active in all stages of the healing process 2
• Currently the only growth factor licensed for wound healing 2

Critical Pitfalls to Avoid

Treatment failure commonly results from inadequate wound care practices:

• Never use becaplermin as monotherapy—it requires concurrent comprehensive wound care 2
• Failure to debride necrotic tissue will prevent healing regardless of becaplermin use 2
• Inadequate offloading negates the benefits of growth factor therapy 2
• Treating infected ulcers without infection control first will result in poor outcomes 2
• Using becaplermin in patients with inadequate vasculature is ineffective 4