CASE STUDY OF FIVE PATIENTS SUFFERING DIABETIC FOOT ULCERS WHO WERE TREATED WITH A NOVEL DEBRIDING BROAD SPECTRUM ANTIMICROBIAL WOUND HEALER:

ASSESSMENT ON T.I.M.E. FRAMEWORK

D Helin1 , A Spyckerelle1, V De Corte², F Michels1, J Van Der Bauwhede1,G Vanhaverbeke 1

1 AZ Groeninge, Campus Onze-Lieve-Vrouw, Diabetic foot clinic, Reepkaai 4, 8500 Kortrijk, Belgium² Flen Pharma NV, Blauwesteenstraat 87, Kontich, Belgium

Introduction

Diabetic foot ulcers remain a significant problem in health care with complications accompanying the disorder, which is a major cause of hospitalization. Although standards of care have been proposed, there is as yet no universal agreement about treatment. Care givers are confronted with a decision about which dressing to choose in order to optimally control exudates as well as keep the wound free from infection. The aim of this study was to assess the therapeutic outcome according to the T.I.M.E. concept in patients treated with a novel wound bio-healer (Flaminal®).

Methods

Five patients with diabetic foot ulcers were seen at a day clinic and the cause of the diabetic foot wound was determined. Wound treatment consisted of rinsing the ulcer with isotonic solution (0.9% NaCl) and disinfection with povidone-iodine solution. Flaminal® was applied to the wounds and size, wound bed status, infection state and wound edges were assessed throughout treatment. In patient 1 and 5, relief of pressure on the foot sole was accomplished using a felt.

Assessment within T.I.M.E. framework

Results

Of the five patients, four were suffering from neuropathy and one from angiopathy. Two patients showed complete recovery of the wounds, one within two months and one within three months. For the other three patients, a significant improvement according to the T.I.M.E. concept was established. There was a reduction in risk of infection. Wound exudate, wound edges and surrounding skin were controlled. All patients showed a favourable outcome of treatment within six months.

Conclusion

Our results showed that the new wound bio-healer (Flaminal®) was effective in the treatment of diabetic foot ulcers according to the T.I.M.E. concept.

20/4/200717/7/2007 2/10/2007

T : necrosis on the

small toe

I : inflammation and high

risk of infection

M : no exudate

E : soft

T : amputation of the toe –

fibrine and presence of a

red wound bed

I : high risk of infection

M : few amounts of exudate

E : no maceration

T : granulation tissue clearly

present

I : no infection

M : minimal amounts of

exudate

E : good closure

Wound was healing optimally

Patient information

Table 1 indicates most important parameters of patients. Bold representstreated ulcer in this study.

11/12/2007

8/1/2008

T : red wound of certain

depth

I : inflammation

M : few amounts of exudate

E : maceration

T : upgranulation of

the wound

I : no inflammation

M : few amounts of exudate

E : no maceration

T : granulation tissue

I : no infection

M : minimal exudate

E : epithelial advancement

Clear progression towards complete healing

20/3/2007 15/5/2007 12/6/2007

T : necrosis – fibrine in

wound bed –1,5 cm

width

I : inflammation – high risk

of infection

M : few to moderate

amounts of exudate

E : red wound edges

T : granulation

I : no infection

M : minimal amounts of

exudate

E : healthy wound edges

Wound almost completely healed

13/2/2007 13/3/2007

T : red-yellow wound

bed – wound of

certain depth

I : risk of infection

M : few to moderate

amounts of exudate

E : callus

T : satisfying granulation –

red wound bed

I : no infection

M : few amounts of exudate

E : healthy wound edges

Diameter of the wound reduced by 50%

T : healed

I : no infection

M : healed

E : healed

Complete healing of wound

T : granulation – red wound

bed

I : no infection

M : few amounts of exudate

E : healthy wound edges

Progression towards healing

Wound progression in time

24/4/2007

8/4/2008

24/7/200716/10/2007

T : red wound bed – 2 cm

diameter

I : high risk of infection

M : few amounts of exudate

E : maceration

T : good granulation – red

wound bed – 1,5 cm

diameter

I : no infection

M : few amounts of exudate

E : healthy wound edges

Satisfying progression of the wound healing process

T : good granulation – 0,5

cm diameter

I : no infection

M : minimal amounts of

exudate

E : healthy wound edges

Optimal healing of the wound

27/6/2007

age medical history

patient 1 63 diabetic type 2 since 1990

insuline since 2000

peripheral vascular insufficiency

arterial hypertension

neuropathic ulcer right foot

patient 2 68

insuline since 2006

chronic kidney insufficiency

angiopathic ulcer amputated toe

patient 3 48

neuropathic foot ulcer thick toe

patient 4 73 diabetic type 2 since 2002

kidney insufficiency

macrovascular deficiency lower leg

surgical intervention carotis

transient ischaemic attack

neuropathic ulcer big toe

patient 5 48 diabetic type 2 since 2002

metformin medication

neuropathic ulcer foot sole

diabetic type 2 since 1985

diabetic nephropathy

diabetic type 1

major microangiopathy