Calcium Dobesilate for Chronic Venous Wounds

• Status: Suspended
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The objective of the study is to assess the efficacy of calcium dobesilate for treating chronic venous wounds.

The hypothesis is that venous ulcers treated with standards measures (compressive measures) and calcium dobesilate will heal-up better than venous ulcers treated with standards measures (compressive measures) and placebo.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundacion Iberoamericana Itaca
• Collaborator: Laboratorios del Dr. Esteve, S.A.
• Treatments: Calcium; Calcium Dobesilate; Calcium, Dietary

Criteria

Inclusion Criteria:

• Patients with venous ulcer (CEAP 6) that affect epidermis, dermis and/or subcutaneous tissue, with and area superior to 3 cm2

• Ankle-arm index 0.9 or superior

• Written informed consent of the patients

Exclusion Criteria:

• Patients with venous ulcer (CEAP 6) that affect bone or with and area inferior to 3 cm2

• Ankle-arm index inferior to 0.9

• No written informed consent of the patients

• Diabetes mellitus I y II

• Patients with renal failure and dialysis

• Vascular surgery needed

• Impossibility to use compressive measures on the leg

• Use of topic antibiotics, silver dressing, growth factors, plasma-rich in platelets, skin graft, pentoxifylline, ultrasounds, laser, hyperbaric oxygen, electric stimulation o vacuum.

• Pregnancy

• Breast feeding

• No anticonceptives measures

• Allergy or intolerance to phebotonics

• Background of neutropenia or leucopenia

• Basal leucocytes < 3.500/ml