Pharmacokinetics of intralesional EGF in patients with diabetic foot ulcers.

Phase 1

Completed

• 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

Study Timeline

• Study Start: 2010-12-24
• Last Update Posted: 2024-08-19

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