Calcium Dobesilate for Chronic Venous Wounds

Randomized, Double-blind Multicenter Clinical Trial Comparing the Efficacy of Calcium Dobesilate With Placebo in the Treatment of Ulcer Secondaries to Chronic Venous Disease

Status

Suspended

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00979836

Enrollment

230

Registered

2009-09-18

Start date

2008-04-30

Completion date

Unknown

Last updated

2011-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcer

Keywords

venous, ulcer, phlebotonic, calcium dobesilate, clinical trial

Brief 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.

Interventions

DRUGCalcium Dobesilate

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Healed venous ulcers	at 6 months of treatment

Secondary

Measure	Time frame
Percentage of re-epithelization area (cm2)	at 6 month of treatment
Length of time to heal ulcers	during all the period of the study (12 months)
Ulcer recurrence	at 12 month
Ulcer pain	at 6 and 12 months
Safety	during the study (12 months)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026