Skin Ulcers Treatment With an Handicraft Topical Device

Foot Ulcer Clinical Trial

Official title: Effectiveness of Topical Negative Handicraft Device for Versus Traditional Conservative Treatment in Skin Ulcers Management in Lower Limb

Status Completed

Clinical Trial Summary

The aim of this study was to evaluate the efficacy of a handicraft topical device of negative pressure versus traditional healing treatment for skin ulcers in lower limbs; in patients with diabetes mellitus, venous stasis and arterial insufficiency.

Clinical Trial Description

The hypothesis of this trial is that the handicraft topical device of negative pressure is even better for the treatment of skin ulcers located in the lower limbs of patients with diabetes mellitus, venous stasis and arterial insufficiency. We anticipate that in a sample of 144 patients with ulcer, will heal or at least improve with this treatment ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Foot Ulcer
• Skin Ulcer
• Ulcer
• Varicose Ulcer

• NCT number: NCT02512159
• Study type: Interventional
• Source: Coordinación de Investigación en Salud, Mexico
• Status: Completed
• Phase: Phase 4
• Start date: March 2014
• Completion date: January 2015