TY - JOUR
T1 - Negative pressure wound therapy after partial diabetic foot amputation
T2 - A multicentre, randomised controlled trial
AU - Armstrong, David G.
AU - Lavery, Lawrence A.
N1 - Funding Information:
This study was funded by KCI USA, the manufacturer of the VAC Therapy Systems. KCI USA organised and implemented the study design by engaging a committee of wound healing experts; employed a staff of study monitors to ensure compliance with source documentation at all sites throughout the study; was not involved in the analysis or write-up of the manuscript, but did review the work before it was released; and did not maintain veto power over the final product. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication.
PY - 2005/11/12
Y1 - 2005/11/12
N2 - 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 ClinicalTrials.gov, 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.
AB - 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 ClinicalTrials.gov, 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.
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U2 - 10.1016/S0140-6736(05)67695-7
DO - 10.1016/S0140-6736(05)67695-7
M3 - Article
C2 - 16291063
AN - SCOPUS:27744496592
SN - 0140-6736
VL - 366
SP - 1704
EP - 1710
JO - Lancet
JF - Lancet
IS - 9498
ER -