Pharmacokinetics of intralesional EGF in patients with diabetic foot ulcers.

• Register: RPCEC
• Last refreshed on: 27 May 2013
• Main ID: RPCEC00000047
• Date of registration: 24/12/2010
• Primary sponsor: Center for Genetic Engineering and Biotechnology (CIGB), Havana.
• Public title: Pharmacokinetics of intralesional EGF in patients with diabetic foot ulcers.
• Scientific title: Pharmacokinetics in intralesional administration of recombinant Epidermal Growth Factor in patients with diabetic foot ulcers.
• Date of first enrolment: 19/11/2007
• Target sample size: 16
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000047-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Double Blind Placebo: Placebo Assignment: Parallel Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Pedro López Saura
• Affiliation: Center for Genetic Engineering and Biotechnology. (CIGB)

• Name: Pedro López Saura
• Affiliation: Center for Genetic Engineering and Biotechnology (CIGB).

Key inclusion & exclusion criteria

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.
Exclusion criteria: 1. Infection signs or symptoms. 2. Osteomyelitis or ulcers with bone exposure. 3. Poorly controlled diabetes mellitus (Hb A1c > 10%). 4. Morbid obesity (body mass index > 40). 5. Connective tissue disease. 6. Use of drugs likely to interfere with (corticoids or inmunosuppressors) or to favor cicatrisation (pentoxifylline, prostaglandin, and other growth factors). 7. Uncontrolled systemic or serious diseases: cardiopathies (especially ischemic cardiopathy or heart failure with edema), moderate or serious liver failure, kidney failure with serum creatinine values >200mmol/l. 8. Clinical malnutrition signs or albumin levels < 35 g/L. Hemoglobin < 100g/L. 9. Hypersensitivity to the product or any of its components. 10. History of current or past neoplasia. 11. Failure to conduct relevant evaluations or keep appropriate drainage in affected limb. 12. Previous EGF treatment. 13. Psychiatric or neurological diseases preventing informed consent. 14. History of alcoholism or drug addiction one year prior to inclusion. 15. Pregnancy or breastfeeding.

Age minimum: 18 years
Age maximum: 70 years
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetic foot ulcer, Wagner grades 1 or 2

Intervention(s)

Group I. EGF-25 µg, administered intralesionally 3 times a week until lesion size is reduced to 1 cm2 or for up to 12 weeks. Group II. EGF-75 µg, 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.

Primary Outcome(s)

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(s)

Ratio of patients with total occlusion 12 weeks after commencing treatment.

Secondary ID(s)

IG/FCEI/PD/0707

Source(s) of Monetary Support

Center for Genetic Engineering and Biotechnology (CIGB). Praxis Pharmaceutical.

Secondary Sponsor(s)

Praxis Pharmaceutical.