None listed
Conditions
Brief summary
Chronic foot wounds tend to take a long time to heal. In an attempt to heal these wounds, standard wound treatment involves the use of gel and foam dressings. This is the treatment you have been receiving so far. These dressings are designed to keep the wound moist but remove excess fluid, to promote the healing process. Vacuum-assisted closure therapy (VAC) is a relatively new treatment for foot wounds. VAC therapy involves the application of negative pressure (like a vacuum) to the wound through a little tube after the wound has been filled with foam and covered with a clear dressing. The vacuum sucks out any fluid in the wound and pulls the wound edges together. There has been some evidence that suggests this therapy assists wound healing. The VAC makes the wound site the best environment for healing to occur by removing the fluid, increasing blood flow and making the wound less suitable for bacteria to grow. The aim of this study is to see whether VAC therapy helps heal these stubborn wounds better than the standard therapy.
Interventions
Patients with foot wound of a volume between 10-100ml or surface area between 5 – 100cm2 that have not healed for a minimum of one month and meet all set criteria (inclusion/exclusion) are invited to participate in the study. Patients are randomised to receive VAC Therapy (KCI) f
Patients with foot wound of a volume between 10-100ml or surface area between 5 – 100cm2 that have not healed for a minimum of one month and meet all set criteria (inclusion/exclusion) are invited to participate in the study. Patients are randomised to receive VAC Therapy (KCI) for a period of 6 weeks. The frequency of the VAC Therapy is for a period of 6 weeks with the device to be on for 22 hours out of 24 hours in a day everyday for the length of the study. If the wound has not healed after 6 weeks with VAC Therapy, patients are to receive standard wound therapy.
Sponsors
KCI Medical Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed