Pharmacokinetics of intralesional EGF in patients with diabetic foot ulcers.

INTERVENTION: Epidermal Growth Factor Group I. EGF‐25 ug, administered intralesionally 3 times a week until lesion size is reduced to 1 cm2 or for up to 12 weeks. Group II. EGF‐75 ug, administered intralesionally 3 times a week until lesion size is reduced to 1 cm2 or for up to 12 weeks. Group III. Placebo, administered intralesionally 3 times a week until lesion size is reduced to 1 cm2 or for up to 12 weeks. EGF bulb reconstitution and dilution will be performed using 5 mL of injection water. CONDITION: Diabetic Foot Diabetic foot ulcer, Wagner grades 1 or 2 PRIMARY OUTCOME: Basal EGF plasma concentration; 5, 15, 30, 45 and 60 minutes after first and last applications, and 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours after first and last applications. SECONDARY OUTCOME: Ratio of patients with total occlusion 12 weeks after commencing treatment. INCLUSION CRITERIA: 1. Patients with DM type 1 or 2 under ADA criteria. 2. Patients of both sexes, aged >= 18 and <= 70. 3. Diabetic foot ulcers classified by Wagner as grade 1 (covering an area >10 and =50 cm2) or grade 2 (covering and area >1 and =50 cm2). 4. Neuropathic ulcer evidenced by palpable distal pulses and ankle/arm index (AA/I) = 0.8 and < 1.3. If arterial calcification occurs (AA/I = 1.3), the finger/arm index (FA/I) will be used. It should be over 0.7. 5. Ulcer = 4 week evolution. 6. Reproductive age men and women should use effective contraceptive methods up to three months after completing treatment. 7. Patients giving informed consent.