Clinical trial, phase II, to evaluate rhEGF efficacy and safety at a dose of 25 or 75 micrograms intralesionally in patients with diabetic foot ulcer (Wagner grade 1 or 2).
- Conditions
- Patients with diabetic foot ulcer (Wagner grade 1 or 2).Diabetic FootFoot UlcerLeg UlcerSkin UlcerDiabetic AngiopathiesVascular DiseasesDiabetes ComplicationsDiabetic NeuropathiesDiabetes Mellitus
- Registration Number
- RPCEC00000048
- Lead Sponsor
- Center for Genetic Engineering and Biotechnology (CIGB), Havana.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- 35
1) Patients with DM type 1 or 2 under ADA criteria. 2) Patients of both sexes, aged >= 18. 3) Diabetic foot ulcers classified by Wagner as grade 1 covering an area >10 and =50 cm2 or grade 2 covering an 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 not exceed 0.7. 5) Ulcer = 4 week evolution. 6) Reproductive age men and women should use effective contraceptive methods for up to three months after completing treatment. 7) Patients should give their consent.
1. Infection signs or symptoms. 2. Osteomyelitis or ulcers with bone exposure. 3. Poorly controlled diabetes mellitus (Hb A1c > 10%). 4. Connective tissue diseases. 5. Use of drugs likely to interfere with (corticoids or inmunosuppressors) or to favor cicatrisation (pentoxifylline, prostaglandin and other growth factors) in the previous 3 weeks. 6. Uncontrolled systemic or serious diseases: cardiopathies (acute myocardial infarction < 3 months, unstable angina or heart failure with edema), moderate or serious liver failure, kidney failure with serum creatinine values > 200mmol/L. 7. Clinical malnutrition signs or albumin levels < 30 g/L. 8. 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 intralesional EGF treatment in current lesion or < 4 weeks in any other lesion, or topical EGF < 4 weeks in current lesion. 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 Total lesion occlusion 12 weeks after commencing treatment. The lesion will be considered occluded when epithelization occurs and there is no secretion and need for dressing. This event will show therapeutic success or failure, respectively.
- Secondary Outcome Measures
Name Time Method Total lesion occlusion at 4th, 8th, 16th, and 20th weeks. Time required for total lesion occlusion. Occlusion in 50% of the initial ulcer area. The number of patients exhibiting 50% of ulcer occlusion at 4th, 8th, 12th, 16th, and 20th weeks will be determined. Time required for 50% lesion occlusion. Development of granular tissue in 90% of lesion area. The number of patients exhibiting this effect at 4th and 8th weeks will be determined. When lesion area is reduced, the granulated and occluded areas are added up, and the percentage based on the area measured before applying the product is calculated. Time required for granular tissue formation in 90% of ulcer area. Systemic EGF concentration after intralesional application.