Pharmacokinetics of intralesional EGF in patients with diabetic foot ulcers.

Pharmacokinetics in intralesional administration of recombinant Epidermal Growth Factor in patients with diabetic foot ulcers.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000047

Enrollment

Registered

2010-12-24

Start date

2007-11-19

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic foot ulcer, Wagner grades 1 or 2

Interventions

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 lesi

Epidermal Growth Factor

Injections, Intralesional

Placebos

RhEGF

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients with DM type 1 or 2 under ADA criteria. 2. Patients of both sexes, aged >= 18 and 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

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Ratio of patients with total occlusion 12 weeks after commencing treatment.	—

Countries

Cuba

Contacts

Public ContactPedro López Saura

Center for Genetic Engineering and Biotechnology (CIGB).

lopez.saura@cigb.edu.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Apr 4, 2026