Calcium Dobesilate for Chronic Venous Wounds

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE3

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Calcium Dobesilate

Group Type EXPERIMENTAL

Calcium Dobesilate

Intervention Type DRUG

500 mg/ three times/day for 6 months (capsules)

Placebo

The placebo is a capsule with the same presence of experimental drug.

Group Type PLACEBO_COMPARATOR

Calcium Dobesilate

Intervention Type DRUG

500 mg/ three times/day for 6 months (capsules)

Interventions

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Calcium Dobesilate

500 mg/ three times/day for 6 months (capsules)

Intervention Type DRUG

Other Intervention Names

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Doxium

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No