CITOPROT-III

Phase 3

Completed

• Conditions: Diabetic foot ulcer.; Foot Ulcer; Diabetic Foot; Leg Ulcer; Skin Ulcer; Diabetic Angiopathies; Vascular Diseases; Diabetes Complications; Diabetic Neuropathies; Diabetes Mellitus

• Registration Number: RPCEC00000060
• Lead Sponsor: Center for Genetic Engineering and Biothecnology (CIGB), Havana.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-26
• Last Update Posted: 2024-08-19

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 147

Inclusion Criteria

1.Diagnosis of diabetic foot ulcer, Wagner's grade 3 or 4. 2.Age = 18 years. 3.Patient’s signed informed consent.

Exclusion Criteria

1.Ulcer area < 1 cm2. 2.Haemoglobin <100 g/l. 3.Uncompensated chronic diseases (ischemic heart illness, diabetic coma or ketoacidosis, renal failure). 4.History or suspect of malignancies (physical examination, rectal tact, breast examination, abdominal ultrasound, thorax radiography and blood chemistry). 5.Use of drugs that can impair evaluation: immunosuppressors or corticosteroids. 6.Psychiatric or neurological diseases that could impair proper reasoning for consent. 7.Pregnancy or nursing.

Study & Design

• Study Type: Interventional
• Study Design: Not specified