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Efficacy of Vacuum Assisted Closure (VAC) Therapy in Healing of Diabetic Foot

Ulcer and after Diabetic Foot Amputation

Article · April 2010

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 Kasr El Aini Journal of Surgery VOL., 11, NO 2 May 2010 57

Efficacy of Vacuum Assisted Closure (VAC) Therapy in Healing of

Diabetic Foot Ulcer and after Diabetic Foot Amputation
Ahmed El-Marakbi, MD, MRCS*, Ahmad Gamal, MD, MRCS*,
Hatem Darwish, MD**, Ahmed Saad, MD***,
* Vascular Department, **Diabetic and Internal Medicine Department,
***Internal Medicine Department.

ABSTRACT
Diabetic foot wounds, particularly those secondary to amputation, are very complex and difficult to treat.
We investigated whether vacuum assisted closure pressure therapy (VAC) improves the proportion and rate
of wound healing for diabetic ulcers and after partial foot amputation in patients with diabetes. 64 patients
with diabetic foot infection were treated in KASER ELAINI hospital, vascular department and the diabetic
foot centre in DR.ERFAN hospital, Jeddah, KSA in the period from April 2005 to April 2008. 32 of these
patients were exposed to VAC dressing for 3-8 weeks with mean period 26 days. Control patients (n=32)
received standard conventional wound care according to consensus guidelines. Inclusion criteria consisted
of partial foot amputation with wounds up to the transmetatarsal level and evidence of adequate perfusion
or infective unhealed ulcers that underwent debridement and drainage with adequate perfusion. More
patients healed on the VAC dressing than in the control group [68.7%] vs. [46.6%]. The rate of wound
healing, based on the time to complete closure, was faster in the VAC group than in control group
(p=0.005). The rate of granulation tissue formation, based on the time to 75-100% formation in the wound
bed, was faster in the VAC 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. Both groups
showed a significant increase in quality of life at the end of therapy and a significant decrease in pain
scores at the end of follow-up. Conclusion: 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. V.A.C. therapy appears to be
superior to conventional wound care techniques.
Key words: Vacuum assisted closure, Diabetic foot ulcer, Diabetic foot infection.

INTRODUCTION to ensure the highest quality and most cost-

Diabetic foot wounds present a great
challenge to wound care practitioners(1), because
these ulcers have a multifactorial aetiology, with
polyneuropathy, biomechanical stress, infection,
deficient footwear and ischemia as the major
factors(2). The principal treatment for diabetic
ulcers is relief of pressure, restoration of skin
perfusion, treatment of infection, intensive
wound care, and metabolic control, treatment of
co morbidity and education of the patient.
Nevertheless, wound healing is slow. A warm,
moist and clean environment must be maintained
to enhance wound healing. Success in these
efforts not only preserves quality of life for
patients with diabetes but is also cost-effective
for the healthcare system(3). Therefore, it is vital
for new methods of treatment to be investigated
effective method of care is always provided. One
such treatment that is worthy of investigation is
vacuum assisted closure (VAC) therapy. We
performed an analysis for the effectiveness of
VAC therapy versus standard moist dressing
technique using hydrogels agents.
PATIENTS & METHODS
All patients that were admitted sufferring
either from infected unhealed ulcer or moist
infective gangrene with or without osteomyelitis
were estimated from period April 2005- April
2008. 64 patients with diabetic foot infection
and/or unhealed ulcers were enrolled in this
study. Thirty two of these patients were exposed
to VAC therapy after either debridement or open
amputations the other thirty two were treated by
 Kasr El Aini Journal of Surgery VOL., 11, NO 2
moist dressing techniques using hydrogels after
definitive treatment in form of amputation or
debridement. All the patients in this study should
have good perfusion. Perfusion was established
in cases with significant arterial tree occlusion or
stenosis either by infrainguinal bypass or
angioplasty and stenting. All patients were
assessed for perfusion and good vasculature
clinically and duplex scanning by measuring
peak systolic velocity at tibial arteries
maintaining PSV at tibial vessels not less than
6ocm/sec and toe pressure not less than 40
mmHg. Both groups were under cover of broad
spectrum of antibiotic according to the severity
of infection and C/S of the wound bacteria. All
the patients were treated under care of vascular
and diabetic foot care, diabetiology and
infectious disease consultants. The protocol of
management of these cases included admission
under care of combined service of both the
vascular and diabetiology departments to
determine the surgical procedure that was
required and to control the level of blood sugar.
Broad spectrum empirical antibiotics were
started for all patients then antibiotics were
modified according to C/S of wounds. Two
weeks course of intravenous antibiotic was the
standard treatment. Extended broad spectrum
antibiotics for six weeks were given in all cases
associated with osteomyelitis. Selected cases
required referral to cardiology and nephrology
departments to adjust and treat associated co-
morbidity. Patients in both groups were also
classified into group has significant arterial
occlusion that required revascularization either
by bypass or angioplasty and another group
without any significant arterial lesion. All
patients were assessed as regards vasculature
clinically and by duplex examination. Further
assessment of vascular tree by MRA, CT
angiography or direct conventional angiography
was done for cases in which revascularization
was required to maintain good perfusion.
Twelve and thirteen patients underwent
revascularization in vacuum and moist dressing
groups respectively. In vacuum group five
patients underwent infrainguinal bypass (three
cases femoro-tibial and two femoro-popliteal
bypasses). Remaining seven patients were
exposed to percutaneous angioplasty and stenting
(four cases, angioplasty and stenting of
femoropopliteal segment, three cases tibial
May 2010 58
angioplasty) while in the other group five also
underwent bypass (one case femoro-tibial and
four femoro-popliteal bypasses). Remaining
eight patients were exposed to percutaneous
angioplasty and stenting (four cases, angioplasty
and stenting of femoropopliteal segment, four
cases tibial angioplasty). Follow up post
revascularization was done by duplex
examination. X ray of foot was done routinely in
all cases and MRI scan was required in selected
cases in which early stage of osteomyelitis was
highly suspicious and not apparent in X ray
films. Plan of management in all patients was
undercover of broad spectrum antibiotics,
debridement and drainage or minor amputation
were done, then revascularization procedure was
done within 48 hours post the debridement or
amputation. With adequate perfusion established
all diabetic feet wounds were dressed either by
vacuum pressure machine or regular moist
dressings using silver impregnated sheets
followed by hydrogel. One year follow up of
healing process till complete healing of the
wounds or till failure of wound healing or major
amputation was needed. In eight patients of the
vacuum group, split thickness grafts were done
to cover large raw foot area post amputation with
healthy granulation tissue and then followed by
application of vacuum machine for another ten
days.
Dressing technique and follow up:
VAC therapy group:
The VAC system dressings are made of
sterile open-cell foam (Figure 1), which is cut to
size and placed into or onto the wound bed. The
wound site is then covered with an adhesive
plastic sheet (Figure 2). We make a small hole in
the centre of the plastic sheet and the tubing is
connected to the sheet, over the hole, by a small
plastic dressing (Figure 3). The farther end of the
tubing is then connected to the VAC pump.
Continuous or intermittent sub atmospheric
suction pressure of approximately 125 mmHg is
then applied to the wound site; although this is
adapted according to the individual's needs.
Special dressing drapes can be obtained for
difficult areas (such as the foot) and new
adhesive strips also assist with maintaining an
airtight seal. Dressing of foam was changed
every 72-96 hours. All patients required
hospitalization. The period of hospitalization in
this group ranged from 1-6 weeks, average 2
 Kasr El Aini Journal of Surgery VOL., 11, NO 2 May 2010 59

weeks period. Split thickness graft was done in prolonged cases after patient and family
eight cases (40.6%) followed by vacuum education with supervision by diabetic foot care
dressing for further 10 days. Ambulatory VAC nurse.
therapy (home care service) was continued for

Figure 1: VAC dressing for diabetic foot ulcer.

Moist dressing technique:
48 hours after definitive treatment, the
dressing was changed and wound was washed
with sterile saline followed by application of
aquacel sheet for minimum one week then after
that the dressing changed to hydrogels. This
group required hospitalization for period ranged
from 1-3 weeks with average period 10 days.
Dressing changed every 24-72 hours according
to the degree of exudates. After discharge of the
patients dressing was done for the patients at
outpatient diabetic clinic.
RESULTS
The patients were classified into two groups,
vacuum dressing group (group I) and moist
dressing group (group II). Both groups were
similar in demographic features as regard mean
age, sex, associated morbidity as shown in table
1.

Demographic features in both groups, table 1.

Patients criteria Vacuum group (group I) Moist group (group II)
N of patients 32 N of patients 32
Age Mean age 62 years Mean age 64 years
Male 20 (62.5%) 18 (56.25%)
IDDM 18 (56.2%) 19 (59.4%)
Hypertension 17 (53.12%) 19 (59.37%)
Anemia 23 (71.18%) 21 (65.62%)
CAD 18 (56.25%) 17 (53.12%)
Dyslipidemia 18 (56.25%) 19 (59.37%)
Renal impairment 10 (31.25%) 8 (25%)
IDDM= insulin dependent diabetes mellitus, CAD= coronary artery disease.
 Kasr El Aini Journal of Surgery VOL., 11, NO 2 May 2010 60

Fifteen cases of group I suffered infected
unhealed ulcers, all of them at planter aspect,
nine of them were located at the heel and six
were at the base of the head of metatarsal bone of
big toe. The remaining seventeen cases of group
I had infected necrotic toes associated with
gangrene in seven patients. Nine patients had
amputation of single toe, three had two toes
amputation and fife had three toes amputation.
In group II, sixteen patients had infected ulcers
and the remaining half suffered infected necrotic
toes. Again similar to the group I all infected
ulcers were located at the planter aspect of the
feet. Six of them were located at the base of head
of metatarsal bone of big toe and ten ulcers at the
heel. Eight patients had amputation of single toe,
three had two toes amputations and fife had three
toes amputation.
Osteomyelitis was detected in nine patients in
each group by x-ray and MRI.
Twelve patients had significant arterial
occlusion or stenosis in group I, all underwent
successful revascularization, either bypass or
angioplasty and stenting. Five patients underwent
infrainguinal bypass (three cases femoro-tibial
and two femoro-popliteal bypasses). Remaining
seven patients were exposed to percutaneous
angioplasty and stenting (four cases, angioplasty
and stenting of femoropopliteal segment, three
cases tibial angioplasty). In group II, five also
underwent bypass (one case femoro-tibial and
four femoro-popliteal bypasses). Remaining
eight patients were exposed to percutaneous
angioplasty and stenting (four cases, angioplasty
and stenting of femoropopliteal segment, four
cases tibial angioplasty).

The two groups were similar in distribution and types of lesion, associated vascular occlusion, and
associated osteomyelitis as shown in table 2.
Patients criteria Vacuum group (group I) Moist group (group II)
N of patients 32 N of patients 32
Infected heel ulcers 9 10
Infected big toe ulcers 6 6
Infected necrotic toes 17 18
Debridement 15 14
Minor amputations 17 18
Associated vascular significant lesions 12 13
Bypass surgery 5 5
Angioplasty +/- stenting 7 8

The period of wound healing was much shorter in VAC therapy (group I) as showed in table 3.
Patients criteria Vacuum group (group I) Moist group (group II)
N of patients 32 N of patients 32
< 3 weeks 9 4
3weeks-3months 8 5
3months-1year 7 14
>1 year 4 3
Failure of healing (major amputation) 3 6

Complete healing of the wounds occurred within three months in 17 (53.12%) and 9 (28.12%) in groups
I and II respectively. It shows significant effect of VAC machine dressing in healing process.
Kasr El Aini Journal of Surgery VOL., 11, NO 2 May 2010 61

Case with huge diabetic foot leg ulcer after 2 weeks VAC therapy

Diabetic foot (heel ulcer) after vac for 3 weeks.

Kasr El Aini Journal of Surgery VOL., 11, NO 2 May 2010 62

A case of 3 months moist regular dressing for severe diabetic foot infections
Kasr El Aini Journal of Surgery VOL., 11, NO 2 May 2010 63

Heel ulcer heeled after 2 months with reguler moist dressing

Huge diabetic ulcer with vac therapy and followed by split thickness graft after 3 weeks duration

Patient with diabetic ulcer with vaccum therapy followed by split thickness graft after 2 weeks
 Kasr El Aini Journal of Surgery VOL., 11, NO 2
DISCUSSION
Using the sub atmospheric pressure of VAC
therapy can alter the wound environment by
reducing bacterial load and chronic, often
inflammatory, interstitial wound exudate;
potentially increasing vascularity and cytokine
expression; and physically contracting wound
margins. All of these characteristics, particularly
the removal of deleterious proteases, may help to
convert a tattered wound bed into a red carpet of
healthy granulation tissue so it may progress
through the subsequent phases of wound healing
(4,5)
. with group of VAC therapy complete heeling of
Since 1995, several studies have looked at the
efficacy of the wound VAC in increasing
granulation tissue and decreasing mean time to
wound closure in various types of chronic
wounds. Morykwas, et. al., performed the initial
studies on animals. Their technique involved
sealing a wound with open-gel foam and suction-
tubing inside and applying sub atmospheric
pressure of 125mmHg below ambient. Using a
porcine model, this study found statistically
significant increases in granulation tissue
production on both the continuous and
intermittent settings (63.3 percent and 103
percent respectively). The investigators also
found a significant decrease in tissue bacterial
counts and a significant increase in random-
pattern flap survival(6,7&8).
The podiatric relevance of VAC therapy has
been anecdotally reported with promising results.
However, only a small number of studies have
been performed. McCallon, et. al., presented a
small randomized trial. Although the study was a
pilot study and was underpowered, the time-to-
healing difference between VAC treatment vs.
saline dressings was somewhat compelling
(23±17 days as compared to 43 +/- 32 days,
respectively) (9, 10).
Armstrong, et. al., reported a retrospective
analysis at the Southern Arizona Veterans
Affairs Medical Center, examining outcome of
sub atmospheric pressure in diabetic wounds.
The purpose of this study was primarily to
determine the average duration of VAC therapy
in treating diabetic foot wounds as well as the
most common complications associated with the
therapy. Thirty-one patients with chronic diabetic
foot ulcerations (mean pre-therapy wound
May 2010 64
duration of 25.4 weeks) were treated with VAC
therapy after aggressive surgical debridement. As
a result, 90.3 percent of wounds healed without
further need for bony resection in a mean time of
8.1 weeks. In their general protocol for the study,
they applied the VAC device until granulation
tissue completely covered periarticular,
tendinous and osseous structures. Researchers
used VAC therapy for a mean time of 4.7 +/- 4.2
weeks, with two weeks as the most commonly
used regimen(11,12).
These results are matched with our results
that showed rapid and early granulation tissues
diabetic wounds in 53% vs 28% in VAC and
moist dressings respectively.
162 patients from 18 centers were included in
a randomized 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(13).
Conclusion:
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.
 Kasr El Aini Journal of Surgery VOL., 11, NO 2
REFERENCES
1. McCallon SK, Knight CA, Calculus JP,
Cunningham MW, McCulloch JM,
Farinas LP. Vacuum-assisted closure
versus saline-moistened gauze in the healing
of postoperative diabetic foot wounds. Ost
Wound Manag 46(8): 28-34, 2000.
2. Bakker K, Schaper NC. New
developments in the treatment of diabetic
foot ulcers Ned Tijdschr Geneeskd
144(9):409-12, 2000.
3. Ballard K, McGregor F. Use of vacuum-
assisted closure therapy following foot
amputation. British Journal of Nursing
10(15 Suppl): 56-12, 2001.
4. Birrer RB, Dellacorte MP, Grisafi PJ.
Prevention and care of diabetic foot ulcers.
American Family Physician 53(2): 601-16,
1996.
5. Blackburn JH 2nd, Boemi L, Hall WW et
al. Negative-pressure dressings as a bolster
for skin grafts. Annals of Plastic Surgery
40(5): 453-57, 1998.
6. Candel Gonzalez FJ, Alramadan M,
Matesanz M et al. Infections in diabetic
foot ulcers. European Journal Intern
Medicine 14(5): 341-43, 2003.
7. Clare MP, Fitzgibbons TC, McMullen ST,
Stice RC, Hayes DF, Henkel L. Experience
with the vacuum assisted closure negative
pressure technique in the treatment of non-
healing diabetic and dysvascular wounds.
May 2010 65
Foot Ankle International 23(10): 896-901,
2002.
8. DeFranzo AJ, Argenta LC, Marks MW et
al. the use of vacuum-assisted closure
therapy for the treatment of lower-extremity
wounds with exposed bone. Plastic
Reconstructive Surgery 108(5): 1184-91,
2001.
9. Domkowski PW, Smith ML, Gonyon DL
Jr et al. Evaluation of vacuum-assisted
closure in the treatment of poststernotomy
mediastinitis. Journal of Thoracic
Cardiovascular Surgery 126(2): 386-90,
2003.
10. Eginton MT, Brown KR, Seabrook GR,
Towne JB, Cambria RA (2003) A
prospective randomized evaluation of
negative-pressure wound dressings for
diabetic foot wounds. Annals of Vascular
Surgery 17(6): 645-49
11. Armstrong DG, Jude EB. The role of
matrix metalloproteinases in wound healing.
J Am Podiatr Med Assoc.; 92(1):12-8, 2002.
12. Armstrong DG, Lavery LA, Abu-
Rumman P, Espensen EH, Vazquez JR,
Nixon BP, Boulton AJM. Outcomes of Sub
atmospheric Pressure Dressing Therapy on
Wounds of the Diabetic Foot. Ost Wound
Manag 48(4): 64-68, 2002.
13. Armstrong DG, Lavery LA, Abu-
Rumman P et al. Outcomes of sub
atmospheric pressure dressing therapy on
wounds of the diabetic foot. Ostomy Wound
Management 48(4): 64-68, 2002.
 Kasr El Aini Journal of Surgery VOL., 11, NO 2 May 2010 66

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