Pharmacokinetics of intralesional EGF in patients with diabetic foot ulcers.

Phase 1

Conditions: Diabetic foot ulcer, Wagner grades 1 or 2
Diabetic Foot
Foot Ulcer
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases
Diabetes Complications
Diabetic Neuropathies
Diabetes Mellitus

Registration Number: RPCEC00000047

Lead Sponsor: Center for Genetic Engineering and Biotechnology (CIGB), Havana.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 16

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures