Armstrong DG, Lavery LA, Diabetic Foot Study Consortium., et al.
Lancet (London, England). Date of publication 2005 Nov 12;volume 366(9498):1704-10.
1. Lancet. 2005 Nov 12;366(9498):1704-10.
Negative pressure wound therapy after partial diabetic foot amputation: a
multicentre, randomised controlled trial.
Armstrong DG(1), Lavery LA; Diabetic Foot Study Consortium.
Author information:
(1)Scholl's Center for Lower Extremity Ambulatory Research (CLEAR), Rosalind
Franklin University of Medicine and Science, Chicago, IL 60064, USA.
Armstrong@usa.net
Comment in
Lancet. 2006 Mar 4;367(9512):726; author reply 726-7.
Lancet. 2006 Mar 4;367(9512):725-6; author reply 726-7.
Lancet. 2006 Mar 4;367(9512):725; author reply 726-7.
BACKGROUND: Diabetic foot wounds, particularly those secondary to amputation, are
very complex and difficult to treat. We investigated whether negative pressure
wound therapy (NPWT) improves the proportion and rate of wound healing after
partial foot amputation in patients with diabetes.
METHODS: We enrolled 162 patients into a 16-week, 18-centre, randomised clinical
trial in the USA. Inclusion criteria consisted of partial foot amputation wounds
up to the transmetatarsal level and evidence of adequate perfusion. Patients who
were randomly assigned to NPWT (n=77) received treatment with dressing changes
every 48 h. Control patients (n=85) received standard moist wound care according
to consensus guidelines. NPWT was delivered through the Vacuum Assisted Closure
(VAC) Therapy System. Wounds were treated until healing or completion of the
112-day period of active treatment. Analysis was by intention to treat. This
study has been registered with , number NCT00224796.
FINDINGS: More patients healed in the NPWT group than in the control group (43
[56%] vs 33 [39%], p=0.040). The rate of wound healing, based on the time to
complete closure, was faster in the NPWT group than in controls (p=0.005). The
rate of granulation tissue formation, based on the time to 76-100% formation in
the wound bed, was faster in the NPWT group than in controls (p=0.002). The
frequency and severity of adverse events (of which the most common was wound
infection) were similar in both treatment groups.
INTERPRETATION: NPWT delivered by the VAC Therapy System seems to be a safe and
effective treatment for complex diabetic foot wounds, and could lead to a higher
proportion of healed wounds, faster healing rates, and potentially fewer
re-amputations than standard care.
DOI: 10.1016/S0140-6736(05)67695-7
PMID: 16291063 [Indexed for MEDLINE]
