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J Wound Ostomy Continence Nurs. 2014;41(3):233-237.

Published by Lippincott Williams & Wilkins

WOUND CARE

Negative Pressure Wound Therapy


in the Treatment of Diabetic
Foot Ulcers
A Systematic Review of the Literature
Alan Guffanti

ABSTRACT
Negative pressure wound therapy (NPWT) is an option
for management of complex wounds such as diabetic
foot ulcers; therefore, the nursing literature from 2000
to 2010 was reviewed for studies comparing clinical
outcomes for diabetic foot ulcers treated with NPWT
and those treated with standard moist wound therapy
(SMWT). PubMed and OVID databases were explored
using the following search terms: vacuum-assisted closure, NPWT, diabetic wounds, and standard most wound
therapy. Research studies to judge efficacy were limited
to the results from studies of experimental studies with
randomized clinical trials on patients with diabetic foot
wounds as the inclusion criteria. Four studies were identified that met the established criteria. Despite variations
in patient population, methodology, and additional
outcome variables studied, NPWT systems were shown to
be more effective than SMWT with regard to proportion
of healed wounds and rate of wound closure.
KEY WORDS: diabetic wounds, negative pressure wound
therapy, standard moist wound therapy, vacuum-assisted
closure.

Introduction
The Centers for Disease Control and Prevention1 defines
diabetes mellitus as a group of diseases characterized by
high levels of blood glucose resulting from defects in insulin production, insulin action, or both. The most common
type of diabetes is type 2, previously called noninsulindependent diabetes mellitus or adult-onset diabetes. The
prevalence of diabetes is significant; the American Diabetes
Association2 stated that 25.8 million individuals in the
United States had diabetes in 2011, representing 8.3% of
the population. The cost of diabetes mellitus was last determined to be $174 in 2007, but better diagnostic tools,
better health care leading to longevity, and better reporting
methodology lead to far greater projected costs per year

for the future. It is believed that approximately $1 in $10


health care dollars in 2010 were attributable to diabetes
mellitus. Indirect costs include increased factors such as
absenteeism, reduced productivity, and lost productive capacity due to disease-associated morbidity and mortality.
Diabetes mellitus is associated with a plethora of comorbid conditions including diabetic foot ulcers.3 Diabetic
foot ulcers are a major reason for hospitalization and limb
loss.4 Neuropathy is a major contributing factor to the development of these ulcers; it is associated with chronic
hyperglycemia and changes in the microvasculature leading to progressive damage to the sensory fibers that normally signal impending foot damage, and an increased
risk of unperceived foot ulcers. The average lifetime risk of
developing a foot ulcer is as high as 25%,4 and foot ulcers
and related complications account for approximately 16%
of all hospital admissions and 23% of all hospital days
among diabetic patients.3
Healing of a diabetic foot ulcer involves the wellestablished processes of inflammation, granulation tissue
formation and epithelialization, and finally maturation of
the scar tissue to provide stable restoration of skin and tissue integrity.5 Topical therapy for diabetic wounds focuses
on standard moist wound therapy (SMWT) as the normative course of treatment, based on a major study in 1962
that definitively established that a clean moist, occluded
wound healed more rapidly than a wound left open to the
air.6 Thus, moist wound therapy is the standard to which
other treatments are compared or supplemented.7
Negative pressure wound therapy (NPWT) has been
described in the literature since the 1940s, but

Alan Guffanti, MSN-CRNP, Nurse Practitioner, Advanced Vascular


Wound Associates, Darby, Pennsylvania.
Correspondence: Alan Guffanti, MSN-CRNP, 101 Summit Lane, Apt
E1, Bala Cynwyd, PA19004 (alan.guffanti@gmail.com).
The author declares no conflicts of interest.
DOI: 10.1097/WON.0000000000000021

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May/June 2014 233

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vacuum-assisted closure (VAC) systems (one type of


NPWT) has been used in the treatment of open wounds on
an anecdotal basis and in small studies since the 1980s.8
The basic components of VAC devices include an opencell polymer foam dressing that conforms to the wound
bed, a transparent film sheet used to seal the dressing, a
plastic drainage tube attached to a collection reservoir and
a vacuum pump that provides intermittent or continuous
pressure, ranging from 25 mmHg through 200 mmHg.9
The negative pressure causes contraction of the dressing
and deformation of the cells in the wound bed, which has
been shown to stimulate neo-angiogenesis and granulation tissue formation. In addition, the negative pressure
provides removal of wound exudate and reduces edema,
which promotes perfusion.9 This type of wound treatment
is performed in a variety of health care settings, including
acute care, home care, long-term acute care, outpatient,
and some long-term care settings, but is always monitored
(either directly or indirectly) by a health care provider
who checks the wound progress by tracking the removal
of fluid, the size of the wound, progress in granulation tissue formation, and who intervenes should there be any
adverse effects.
Case studies and small comparative studies have been
reported that compare wound healing outcomes for patients managed with NPWT to those managed with
SMWT.10 However, recommendations for changes in routine management of diabetic foot ulcers require demonstrated benefit across multiple studies with larger numbers
of patients, and specifically studies involving diabetic foot
ulcers. It is also important to consider the cost of treatment in comparison to outcomes, since VAC is considerably more expensive than SMWT. Nonetheless, VAC
therapy may prove to be more cost-effective than SMWT,
if VAC therapy provides a significant reduction in healing
time and overall resource utilization. This literature review
was undertaken to address the following questions: (1) Is
NPWT clinically more effective than SMWT for wound
healing in patients with a diabetic foot ulcer, (2) is NPWT
more effective than SMWT in patients with a diabetic foot
ulcer, with regard to promotion of faster wound closure
rate, and (3) is NNPWT more effective than SMWT in patients with a diabetic foot ulcer, with regard to safety and
reduction in secondary complications?

Methods
A review of the major nursing journal databases PubMed
and OVID from 2000 to 2010 was completed using the key
words vacuum assisted closure, negative pressure wound
therapy, diabetic wounds, and standard moist wound
therapy. Criteria for inclusion in this review included randomized clinical trials involving patients with diabetic foot
ulcers and which comparing NPWT to SMWT. A total of 6
studies were found, and 4 met inclusion criteria.

May/June 2014

Results
Patients in all 4 studies had chronic or acute diabetic foot
wounds although the severity and precursor condition (partial foot amputation) varied.4,7,11,12 Patient demographics
(age, ethnic group, etc) and exclusion criteria varied from
study to study. For example, Etoz11 excluded patients who
had arterial insufficiency as evidenced by absence of pedal
pulses; this was not an exclusion criterion in the other 3
studies. The only exclusion criteria that were consistent for
all 4 studies were ulcer malignancy, current treatment with
corticosteroids or radiotherapy, underlying osteomyelitis,
sepsis, pregnancy, and nursing mothers.4,7,11,12
Prior to treatment assignment in all 4 studies, wounds
were debrided of nonviable tissue.4,7,11,12 In 3 of the studies,
systemic antibiotic therapy was given to all patients for
prophylaxis following surgical debridement.4,7,11,12 Patients
were randomly assigned to the experimental intervention
(VAC) or SMWT in all studies. No studies were identified
in which NPWT techniques other than VAC were used.
The amount of continuous negative pressure was
125 mmHg, according to standard treatment guidelines.
Dressing changes varied from every 24 hours to every
48 hours to 3 times per week.4,7,11,12
Patients in the comparison groups received SMWT.
However, variations in SMWT were noted. Patients in the
Etoz study received traditional moist saline dressings
changed twice a day,11 while participants in the study by
Blume and colleagues7 received advanced dressings (predominantly hydrogels and alginates) according to guidelines published by the Wound, Ostomy and Continence
Nurses Society and institutional protocols. Comparison
group patients in the Armstrong and colleagues4 study
also were managed with advanced wound dressings (alginates, hydrocolloids, foams, or hydrogels); the attending
clinician selected the specific dressing based on standardized guidelines and an individualized assessment of
wound status. In the study by Sepulveda and colleagues,12
the specific dressing was chosen according to the saturation of the secondary bandage. If the bandage presented a
rate of saturation lower than 50%, the wound was dressed
with a hydrocolloid gel, tulle (woven gauze) impregnated
with a petrolatum emulsion, and a bandage. In contrast,
if the saturation of the dressing was greater than 50%, the
wound was covered with an alginate and a bandage.
Question 1: Is NPWT more effective than SMWT for wound
healing in patients with a diabetic foot ulcer?
The evidence from these studies suggests that NPWT
using a VAC system promotes healing of diabetic foot ulcers, and in some cases, complete reepithelialization.4,7,11,12
In the study by Blume and colleagues,7 the proportion of
ulcers with complete closure was significantly greater
(P = .007) for patients receiving NPWT as compared to
SMWT. Similarly, in the study by Armstrong and
colleagues,4 a higher percentage of patients healed with

Copyright 2014 Wound, Ostomy and Continence Nurses Society. Unauthorized reproduction of this article is prohibited.

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NPWT than with the control treatment, 56% versus 39%
(P = .040). Etoz11 also observed a significant difference in
the number of days required for complete or near complete granulation of the wound bed without any infection,
11.25 days for patients receiving NPWT and 15.7 days for
those receiving SMWT (P = .05). In the study by Sepulveda
and colleagues,12 90% granulation took 18.6 days for patients managed with NPWT versus 32.3 days for patients
managed with SMWT (P = .007).
The endpoints were similar in all studies. In the Blume7
study, the primary endpoint was complete ulcer closure,
defined as 100% reepithelialization. Sepulveda and colleagues12 defined the endpoint as 90% granulation, and
although Etoz did not define the endpoint definitely by
complete granulation, he noted that the criteria for the
end point was no sign of inflammation and readiness for
surgical closure almost complete granulation with no
signs of inflammation.11 However, not all patients in these
studies reached the treatment endpoints; this was particularly true of the patients managed with SMWT. In the
Armstrong and colleagues,4 study patients were treated
until wounds were healed or until completion of the
112-day period of active treatment.
Considered collectively evidence from these 4 studies
suggests that NPWT is clinically more effective than
SMWT for wound healing in patients with a diabetic foot
ulcer. Specifically, more patients experienced wound improvement or complete wound closure when managed
with NPWT as opposed to SMWT.4,7,11,12
Question 2: Is NPWT more effective than SMWT in patients
with a diabetic foot ulcer, with regard to promotion of
faster wound closure rate?
It has been reported that NPWT decreases bacterial
colonization and interstitial edema. It also increases capillary blood flow and removes fluid from the wound, which
is hypothesized to promote rapid formation of granulation tissue required for wound closure. Furthermore,
NPWT reduces wound surface area by the traction force of
negative pressure and increases mitotic activity among
cells responsible for collagen synthesis and epithelial
resurfacing.9
Etoz11 measured wound surface area every 48 hours in
patients in both the treatment and comparison groups;
wound therapy was continued until the wound bed was
almost completely granulated and there was no sign of
inflammation. Before treatment, the mean wound surface
area was not significantly different between the experimental and control groups. However, within 1 week there
was an increased amount of granulation tissue and a decreased amount of nonviable tissue among wounds in the
NPWT group. At study endpoint, the mean wound surface
area decreased 20.4 cm2 (range, 88.6-109.0 cm2) in the
NPWT group versus a men decrease of 9.5 cm2 (range,
85.3-94.8 cm2) in the control group; this difference was
statistically significant (P = .032).

Guffanti

235

In the study by Armstrong and colleagues,4 the rate of


wound healing, based on the time to complete closure,
was faster in the NPWT group than in the control group
(P = .005), and the rate of granulation tissue formation,
based on the time to 76% to 100% formation in the wound
bed, was faster in the NPWT group than in the control
group (P = .002).
The reduction in wound surface area over a defined
period of time reflects the rate at which the ulcer is healing. Though not reaching complete closure, Blume and
colleagues7 reported that the surface area of the wounds in
the NPWT group was smaller than wounds in the SMWT
group (P = .032).7 A significant difference in size on day 28
(change of 4.32 cm2 vs 2.53 cm2, P = .021) was also noted
and the time to 75% closure was significant (54 vs 84 days)
(P = .014). In summary, the data from these studies suggest that NPWT using a VAC system promotes more rapid
closure of diabetic foot ulcers than SMWT.4,7,11,12
Question 3: Is NPWT more effective than SMWT in patients
with a diabetic foot ulcer, with regard to safety and reduction in secondary complications?
Secondary complications associated with diabetic foot
ulcers vary, but most commonly involve various infectious complications and wound deterioration resulting in
amputation. Wound complications in the studies reviewed
were typical for diabetic foot ulcers and included wound
infections, cellulitis, osteomyelitis, edema, and the need
for amputation.
Blume and colleagues7 found significantly fewer secondary amputations for patients assigned to the NPWT
treatment group versus those treated with SWMT (4.1% vs
10.2% P < .035). In contrast, Armstrong and colleagues4
found no significant differences in secondary amputation
rates when comparing NPWT and SMWT (3% vs 11%,
P = .6). The relative risk ratio (0:225) indicated that patients treated with NPWT were less likely than control patients to undergo secondary amputation. However, this
finding must be viewed with caution in light of the 95%
confidence interval (0.05-1.1).
Blume and colleagues7 evaluated differences between
MPWT and SMWT groups at 6 months (incidence of
wound infections, edema, cellulitis, and osteomyelitis)
and found no statistically significant differences.
Armstrongs group4 also found no significant differences
in the frequency and severity of adverse events among the
2 groups (42% vs 54%, P = .875).
Apelqvist and colleagues13 examined the data collected
in the Armstrong4 study and noted that significantly more
surgical procedures including debridement were performed in the SMWT group than in the NPWT group
(120 vs 43, P < .001). This finding suggests that recurrence
of nonviable tissue was more likely among the group managed with SMWT, which is consistent with the results of
Etoz,11 who reported that the NPWT group had increased
granulation tissue and decreased nonviable tissue when

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May/June 2014

TABLE 1.

Summary Results of Studies Reviewed


Author/Participants

Intervention

Results

Treatment
NPWT

Control
SMWT

43 (56%)
42
40 (52%)

33 (39%)
84
46 (54%)

73 (43.2%)
56
7 (4%)

48 (28.9%)
114
17 (10%)

Armstrong et al4 162 patients with diabetic


foot ulcers

NPWT (n = 77)
SMWT (n = 85)

n (%) patients w/complete closure


# days to reach 75% granulation
n (%) patients w/ 1 or more adverse events

Blume et al7 342 patients with diabetic foot


ulcers

NPWT (n = 169)
SMWT (n = 166)

n (%) patients with complete closure


# days to 75%-100% ulcer closure
n (%) patients w/ secondary amputations

Etoz11 24 patients with diabetic foot ulcers

NPWT (n = 12)
SMwT (n = 12)

length of cared
wound surface decrease, cm

11.23
20.4

15.75
9.5

Sepulveda et al12 24 patients with diabetic


foot ulcers

NPWT (n = 12)
SMWT (n = 12)

Patients reaching 90% granulation, n


No. of days to reach 90% granulation
Patients w/ infection, n

12
18.8
0

11
32.2
1

Abbreviations: NPWT, negative pressure wound therapy; SMWT, standard moist wound therapy.

compared to the SMWT group. Edema of the extremities


diminished in patients in both groups, as did the surface
area of diabetic foot ulcers (P = .05).11

Discussion
Findings from these 4 studies suggest that outcomes using
NPWT via a VAC system were favorable when compared to
the SMWT in the treatment of diabetic foot ulcers.
Specifically, the data suggest that VAC therapy promotes
faster reduction in wound surface area through granulation tissue formation and reepithelialization, reduces time
to healing, and may reduce the incidence of infectious
complications (Table 1).
These data also indicate that NPWT is associated with
no more adverse side effects than SMWT. Nevertheless,
NPWT should be implemented as one element of a comprehensive management program that includes effective
offloading of plantar surface ulcers and tight glucose control in addition to local wound care. As noted by all the
investigators, surgical debridement is an essential first
step in local wound care and should be initiated prior to
using NPWT. NPWT can then be used either to promote
primary wound healing or to prepare a wound for surgical
closure.
Further research is needed to address limitations of
these studies that do not control for age, sex, race, and
type and severity of the diabetic foot wound. Refining the
demographic variables as well as narrowing the type of
diabetic foot wound might lead to better criteria for the
use of VAC. Further research is also needed to address resource utilization and costs that might lead to more informed decisions on where and when to use the VAC.
Finally areas of investigation should address the efficacy of
NPWT systems other than VAC and should explore situations in which NPWT is and is not likely to be as effective.

KEY POINTS

Evidence from 4 randomized controlled trials suggests that


NPWT using a VAC system is more effective than SMWT in
promoting the healing of diabetic foot wounds.
Evidence from 4 randomized controlled trials suggests that
NPWT using a VAC system is more effective than SMWT in
promoting faster healing of diabetic foot wounds.
Recommendations for Clinical Practice
1. NPWT should be considered as one of multiple options in a comprehensive treatment plan for patients
with diabetic foot ulcers.
2. The condition of any wound requiring medical management should be comprehensively assessed with regard to underlying causes, systemic factors, and conditions at the wound in order to develop a plan of care
that should be continually reassessed to determine if
progress toward healing is being made.

Conclusion
Findings from these studies provide evidence that NPWT
is safe and effective for management of diabetic foot ulcers. Nevertheless, NPWT should be implemented as one
element of a comprehensive management program that
includes effective offloading of plantar surface ulcers and
tight glucose control in addition to local wound care.

References
1. Centers for Disease Control and Prevention. 2011 National
Diabetes Fact Sheet. http://www.cdc.gov/diabetes/pubs/
estimates11.htm. Published 2011. Accessed March 25, 2014.

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Guffanti

2. American Diabetes Association. Diabetes statistics. http://


www.diabetes.org/diabetes-basics/diabetes-statistics/. Accessed
March 25, 2014.
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2007;7(5):230-234. DOI: 10.1177/1474651407007005060
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Medical-Surgical Nursing: Assessment and Management of Clinical
Problems. St Louis, MO: Mosby Elsevier; 2007.
6. Winter GD. Formation of the scab and the rate of epithelialization of superficial wounds in the skin of the young domestic
pig. Nature. 1962;193:293.
7. Blume PA, Walters J, Payne W, Ayala J, Lantis J. Comparison of
negative pressure wound therapy using vacuum-assisted closure
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Diabetes Care. 2008;31(4):631-636. DOI: 10.2337/dc07-2196
8. Penny HL, Dyson M, Spinazzola J, Green A, Faretta M, Meloy
G. The use of negative-pressure wound therapy with bio-dome
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DOI: 10.1097/WON.0000000000000038

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