The VAC Trial

Phase 4

• Conditions: Patients with chronic foot wound which have not healed; Other -

• Registration Number: ACTRN12606000384550
• Lead Sponsor: KCI Medical Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-08-31
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Patients are eligible to be included in the study only if they meet all of the following criteria:1.Provide signed informed consent. 2.Have foot wounds. 3.Have or preoperatively had toe pressures >30mmHg or palpable toe pressures. 4.Have wounds that have not healed in 1 month. 5.Wound volume is between 10 –100 ml or surface area is between 5 –100 cm2 , after debridement 6.Wounds are suitable to be managed at home. 7.Patients with a diabetic foot ulcer, with toe pressures greater than 30mmHg or palpable toe pressures.

Exclusion Criteria

1.Have malignancy in the wound2.Untreated osteomyelitis3.Non-enteric and unexplored fistula4.Necrotic tissue with eschar present5.Active bleeding6.Difficult wound hemostasis7.Patient is on anticoagulants8.Wound has exposed blood vessels or organs9.Patients have irradiated, weakened or sutured blood vessels10.Patient has within the last 30 days / is undergoing hyperbaric oxygen therapy11.Patients have allergies to adhesive drape12.Patients are to have surgical interventionsFor statistical purposes, both males and females are included in this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified