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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-

effective method of care is always provided. One
Diabetic foot wounds present a great such treatment that is worthy of investigation is
challenge to wound care practitioners(1), because vacuum assisted closure (VAC) therapy. We
these ulcers have a multifactorial aetiology, with performed an analysis for the effectiveness of
polyneuropathy, biomechanical stress, infection, VAC therapy versus standard moist dressing
deficient footwear and ischemia as the major technique using hydrogels agents.
factors(2). The principal treatment for diabetic
ulcers is relief of pressure, restoration of skin PATIENTS & METHODS
perfusion, treatment of infection, intensive
wound care, and metabolic control, treatment of All patients that were admitted sufferring
co morbidity and education of the patient. either from infected unhealed ulcer or moist
Nevertheless, wound healing is slow. A warm, infective gangrene with or without osteomyelitis
moist and clean environment must be maintained were estimated from period April 2005- April
to enhance wound healing. Success in these 2008. 64 patients with diabetic foot infection
efforts not only preserves quality of life for and/or unhealed ulcers were enrolled in this
patients with diabetes but is also cost-effective study. Thirty two of these patients were exposed
for the healthcare system(3). Therefore, it is vital to VAC therapy after either debridement or open
for new methods of treatment to be investigated amputations the other thirty two were treated by
 Kasr El Aini Journal of Surgery VOL., 11, NO 2 May 2010 58

moist dressing techniques using hydrogels after angioplasty) while in the other group five also
definitive treatment in form of amputation or underwent bypass (one case femoro-tibial and
debridement. All the patients in this study should four femoro-popliteal bypasses). Remaining
have good perfusion. Perfusion was established eight patients were exposed to percutaneous
in cases with significant arterial tree occlusion or angioplasty and stenting (four cases, angioplasty
stenosis either by infrainguinal bypass or and stenting of femoropopliteal segment, four
angioplasty and stenting. All patients were cases tibial angioplasty). Follow up post
assessed for perfusion and good vasculature revascularization was done by duplex
clinically and duplex scanning by measuring examination. X ray of foot was done routinely in
peak systolic velocity at tibial arteries all cases and MRI scan was required in selected
maintaining PSV at tibial vessels not less than cases in which early stage of osteomyelitis was
6ocm/sec and toe pressure not less than 40 highly suspicious and not apparent in X ray
mmHg. Both groups were under cover of broad films. Plan of management in all patients was
spectrum of antibiotic according to the severity undercover of broad spectrum antibiotics,
of infection and C/S of the wound bacteria. All debridement and drainage or minor amputation
the patients were treated under care of vascular were done, then revascularization procedure was
and diabetic foot care, diabetiology and done within 48 hours post the debridement or
infectious disease consultants. The protocol of amputation. With adequate perfusion established
management of these cases included admission all diabetic feet wounds were dressed either by
under care of combined service of both the vacuum pressure machine or regular moist
vascular and diabetiology departments to dressings using silver impregnated sheets
determine the surgical procedure that was followed by hydrogel. One year follow up of
required and to control the level of blood sugar. healing process till complete healing of the
Broad spectrum empirical antibiotics were wounds or till failure of wound healing or major
started for all patients then antibiotics were amputation was needed. In eight patients of the
modified according to C/S of wounds. Two vacuum group, split thickness grafts were done
weeks course of intravenous antibiotic was the to cover large raw foot area post amputation with
standard treatment. Extended broad spectrum healthy granulation tissue and then followed by
antibiotics for six weeks were given in all cases application of vacuum machine for another ten
associated with osteomyelitis. Selected cases days.
required referral to cardiology and nephrology Dressing technique and follow up:
departments to adjust and treat associated co- VAC therapy group:
morbidity. Patients in both groups were also The VAC system dressings are made of
classified into group has significant arterial sterile open-cell foam (Figure 1), which is cut to
occlusion that required revascularization either size and placed into or onto the wound bed. The
by bypass or angioplasty and another group wound site is then covered with an adhesive
without any significant arterial lesion. All plastic sheet (Figure 2). We make a small hole in
patients were assessed as regards vasculature the centre of the plastic sheet and the tubing is
clinically and by duplex examination. Further connected to the sheet, over the hole, by a small
assessment of vascular tree by MRA, CT plastic dressing (Figure 3). The farther end of the
angiography or direct conventional angiography tubing is then connected to the VAC pump.
was done for cases in which revascularization Continuous or intermittent sub atmospheric
was required to maintain good perfusion. suction pressure of approximately 125 mmHg is
Twelve and thirteen patients underwent then applied to the wound site; although this is
revascularization in vacuum and moist dressing adapted according to the individual's needs.
groups respectively. In vacuum group five Special dressing drapes can be obtained for
patients underwent infrainguinal bypass (three difficult areas (such as the foot) and new
cases femoro-tibial and two femoro-popliteal adhesive strips also assist with maintaining an
bypasses). Remaining seven patients were airtight seal. Dressing of foam was changed
exposed to percutaneous angioplasty and stenting every 72-96 hours. All patients required
(four cases, angioplasty and stenting of hospitalization. The period of hospitalization in
femoropopliteal segment, three cases tibial 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: patients dressing was done for the patients at
48 hours after definitive treatment, the outpatient diabetic clinic.
dressing was changed and wound was washed
with sterile saline followed by application of RESULTS
aquacel sheet for minimum one week then after
that the dressing changed to hydrogels. This The patients were classified into two groups,
group required hospitalization for period ranged vacuum dressing group (group I) and moist
from 1-3 weeks with average period 10 days. dressing group (group II). Both groups were
Dressing changed every 24-72 hours according similar in demographic features as regard mean
to the degree of exudates. After discharge of the 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 Osteomyelitis was detected in nine patients in
unhealed ulcers, all of them at planter aspect, each group by x-ray and MRI.
nine of them were located at the heel and six Twelve patients had significant arterial
were at the base of the head of metatarsal bone of occlusion or stenosis in group I, all underwent
big toe. The remaining seventeen cases of group successful revascularization, either bypass or
I had infected necrotic toes associated with angioplasty and stenting. Five patients underwent
gangrene in seven patients. Nine patients had infrainguinal bypass (three cases femoro-tibial
amputation of single toe, three had two toes and two femoro-popliteal bypasses). Remaining
amputation and fife had three toes amputation. seven patients were exposed to percutaneous
In group II, sixteen patients had infected ulcers angioplasty and stenting (four cases, angioplasty
and the remaining half suffered infected necrotic and stenting of femoropopliteal segment, three
toes. Again similar to the group I all infected cases tibial angioplasty). In group II, five also
ulcers were located at the planter aspect of the underwent bypass (one case femoro-tibial and
feet. Six of them were located at the base of head four femoro-popliteal bypasses). Remaining
of metatarsal bone of big toe and ten ulcers at the eight patients were exposed to percutaneous
heel. Eight patients had amputation of single toe, angioplasty and stenting (four cases, angioplasty
three had two toes amputations and fife had three and stenting of femoropopliteal segment, four
toes amputation. 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 May 2010 64

DISCUSSION duration of 25.4 weeks) were treated with VAC

therapy after aggressive surgical debridement. As
Using the sub atmospheric pressure of VAC a result, 90.3 percent of wounds healed without
therapy can alter the wound environment by further need for bony resection in a mean time of
reducing bacterial load and chronic, often 8.1 weeks. In their general protocol for the study,
inflammatory, interstitial wound exudate; they applied the VAC device until granulation
potentially increasing vascularity and cytokine tissue completely covered periarticular,
expression; and physically contracting wound tendinous and osseous structures. Researchers
margins. All of these characteristics, particularly used VAC therapy for a mean time of 4.7 +/- 4.2
the removal of deleterious proteases, may help to weeks, with two weeks as the most commonly
convert a tattered wound bed into a red carpet of used regimen(11,12).
healthy granulation tissue so it may progress These results are matched with our results
through the subsequent phases of wound healing that showed rapid and early granulation tissues
(4,5)
. with group of VAC therapy complete heeling of
Since 1995, several studies have looked at the diabetic wounds in 53% vs 28% in VAC and
efficacy of the wound VAC in increasing moist dressings respectively.
granulation tissue and decreasing mean time to 162 patients from 18 centers were included in
wound closure in various types of chronic a randomized clinical trial in the USA. Inclusion
wounds. Morykwas, et. al., performed the initial criteria consisted of partial foot amputation
studies on animals. Their technique involved wounds up to the transmetatarsal level and
sealing a wound with open-gel foam and suction- evidence of adequate perfusion. Patients who
tubing inside and applying sub atmospheric were randomly assigned to NPWT (n=77)
pressure of 125mmHg below ambient. Using a received treatment with dressing changes every
porcine model, this study found statistically 48 h. Control patients (n=85) received standard
significant increases in granulation tissue moist wound care according to consensus
production on both the continuous and guidelines. NPWT was delivered through the
intermittent settings (63.3 percent and 103 Vacuum Assisted Closure (VAC) Therapy
percent respectively). The investigators also System. Wounds were treated until healing or
found a significant decrease in tissue bacterial completion of the 112-day period of active
counts and a significant increase in random- treatment. Analysis was by intention to treat.
pattern flap survival(6,7&8). This study has been registered with, number
The podiatric relevance of VAC therapy has NCT00224796. FINDINGS: More patients
been anecdotally reported with promising results. healed in the NPWT group than in the control
However, only a small number of studies have group (43 [56%] vs. 33 [39%], p=0.040). The
been performed. McCallon, et. al., presented a rate of wound healing, based on the time to
small randomized trial. Although the study was a complete closure, was faster in the NPWT group
pilot study and was underpowered, the time-to- than in controls (p=0.005). The rate of
healing difference between VAC treatment vs. granulation tissue formation, based on the time to
saline dressings was somewhat compelling 76-100% formation in the wound bed, was faster
(23±17 days as compared to 43 +/- 32 days, in the NPWT group than in controls (p=0.002).
respectively) (9, 10). The frequency and severity of adverse events (of
Armstrong, et. al., reported a retrospective which the most common was wound infection)
analysis at the Southern Arizona Veterans were similar in both treatment groups(13).
Affairs Medical Center, examining outcome of Conclusion:
sub atmospheric pressure in diabetic wounds. The VAC Therapy System seems to be a safe
The purpose of this study was primarily to and effective treatment for complex diabetic foot
determine the average duration of VAC therapy wounds, and could lead to a higher proportion of
in treating diabetic foot wounds as well as the healed wounds, faster healing rates, and
most common complications associated with the potentially fewer re-amputations than standard
therapy. Thirty-one patients with chronic diabetic care.
foot ulcerations (mean pre-therapy wound
 Kasr El Aini Journal of Surgery VOL., 11, NO 2 May 2010 65

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 Kasr El Aini Journal of Surgery VOL., 11, NO 2 May 2010 66

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