How is recombinant epidermal growth factor (recombinant EGF) ointment used to treat bedsores (pressure ulcers) and what is its effectiveness?

Recombinant EGF Ointment for Bedsores: Limited Evidence Does Not Support Routine Use

Based on the most recent and highest quality guideline evidence, recombinant epidermal growth factor (rhEGF) ointment should not be routinely used for treating pressure ulcers (bedsores), as the evidence remains insufficient and conflicting despite its widespread use in some countries. 1

Evidence Quality and Recommendations

Guideline Position on EGF for Chronic Ulcers

The International Working Group on the Diabetic Foot (IWGDF) 2020 guidelines—the most recent authoritative source—explicitly state that despite widespread use of EGF in some countries, only three moderate to high-scoring RCTs have been identified with conflicting results, and no clear outcomes in terms of healing or area reduction have been demonstrated. 1

The 2020 IWGDF systematic review found seven older studies of EGF with significant methodological limitations:

• Studies showed mixed results with no consistent benefit 1
• All studies on EGF were found to be at high risk of bias with significant limitations in study methodology, description of intervention and control care, and unclear statistical methods 1
• No recent controlled studies of EGF have been found, making it unclear whether EGF could improve ulcer healing when used with modern standards of care 1

Critical Limitation: Pressure Ulcers vs. Diabetic Foot Ulcers

Important caveat: The available guideline evidence specifically addresses diabetic foot ulcers, not pressure ulcers (bedsores). 1 The American College of Physicians 2015 guideline on pressure ulcer treatment does not mention EGF among evaluated therapies, suggesting insufficient evidence for this specific indication. 1

Application Method (When Used Despite Limited Evidence)

If rhEGF is used based on individual clinical judgment in settings where it is available, the research literature describes these protocols:

Topical Application

• Concentration: 0.005% rhEGF (10 μg/g) appears optimal based on dose-ranging studies 2, 3
• Frequency: Twice daily application to the wound bed 2, 4
• Preparation: Must be combined with wound debridement and advanced dressings (hydrocolloid or composite dressings) 2
• Duration: Treatment continued until healing or for 8-12 weeks 2, 4

Intralesional Injection (Alternative Route)

• Dose: 75 μg rhEGF three times per week for 5-8 weeks 5
• Route: Perilesional injections into wound margins 5
• Context: Used primarily for advanced diabetic foot ulcers with amputation risk 5

Effectiveness Data: Conflicting and Context-Dependent

Studies Showing Potential Benefit

• One RCT (n=167) found topical 0.005% rhEGF spray significantly improved complete ulcer healing at 12 weeks (healing rate difference approximately 20%, P=.001) 1
• A small study (n=34) showed 75 μg applied three times weekly increased healing proportion, but had suboptimal offloading and only 8-week assessment 1
• Observational data from 89 diabetic foot ulcer patients showed 76% complete healing within average 46 days when EGF was added after failed standard dressing treatment 2

Studies Showing No Benefit

• Multiple double-blind RCTs of rhEGF gel showed no benefit overall or unclear findings 1
• One study including leg ulcers showed no difference in healing by 16 weeks 1
• Methodological problems plague most positive studies, including poor control group healing rates and inadequate description of standard care 1

Critical Pitfalls and Contraindications

Major Concerns

• Cost without proven cost-effectiveness: No health economic data support routine use 1
• Requires optimal standard care first: EGF should never substitute for proper wound debridement, pressure offloading, infection control, and nutritional optimization 2
• Quality of evidence: The 2020 IWGDF strongly recommends not using topical growth factors in hard-to-heal diabetic foot ulcers due to poor evidence 1

When NOT to Use

• As first-line therapy before establishing adequate standard wound care 1
• In infected, ischemic, or necrotic wounds without addressing underlying pathology 1
• When adequate pressure relief and nutritional support are not in place 1

Alternative Evidence-Based Approaches for Pressure Ulcers

The American College of Physicians 2015 guideline provides stronger evidence for:

• Air-fluidized beds (moderate-quality evidence for reducing ulcer size) 1
• Protein-containing supplements (moderate-quality evidence for improved healing) 1
• Electrical stimulation as adjunctive therapy (moderate-quality evidence for accelerated healing) 1
• Hydrocolloid dressings over gauze (low-quality evidence for reduced ulcer size) 1

Clinical Bottom Line

The current evidence does not support routine use of recombinant EGF ointment for pressure ulcers. 1 While some research studies show potential benefit in diabetic foot ulcers, the evidence is old, conflicting, and methodologically flawed. 1 No guideline recommends EGF for pressure ulcers specifically, and the most recent diabetic foot ulcer guidelines recommend against using topical growth factors. 1 Focus should remain on proven interventions: appropriate support surfaces, adequate nutrition, proper wound care, and pressure relief. 1