CITOPROT-III

Phase 3

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

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

Primary Outcome Measures

Name	Time	Method
Primary outcome variable: Proportion of patients with >50% granulation response after 2 weeks of treatment. Useful productive material is that able to lead to complete lesion closure by second intention or to sustain and feed an autograft. It is characterized macroscopically by the presence of granular, reddish, diffuse, disperse, shining, and easily bleeding formations. Response is classified according to the percent of the lesion area covered by granulation tissue: 1.No response: 0 – 25% 2.Minimal response: 26 – 50% 3.Partial response: 51 – 75% 4.Complete response: > 75 % Partial or complete response at 2 weeks of treatment are considered therapeutic success. No response or minimal response are considered failures.

Secondary Outcome Measures

Name	Time	Method
1.Proportion of patients that achieve complete granulation response at the end of treatment. 2.Time to complete granulation response. 3.Proportion of patients that reaches complete healing up to one year follow-up, defined as wound epithelization and complete closure, without secretion or need of bandage. 4.Need for major amputation. 5.Recurrence, defined as the appearance of a new ulcer on the same limb, both at the same previously affected site or at a new site.