limb salvage: the wound salvage the wound center...in the management of diabetic foot ulcers.”...

Limb Salvage: The Wound

Center Approach

Why Not?

“In the 39th year of his reign, King Asa was

afflicted with a disease in his feet. Though the

disease was severe, even in his illness, he did not

seek help from the Lord, but only from the

physicians. Then in the 41st year of his reign Asa

died and rested with his fathers.”

II Chronicles 16:12-14 Compliments of Dr. Wayne Caputo, Belleville, NJ

“He is a good surgeon who can

amputate a limb, but he is a better

surgeon who can save a limb.”

Sir Astley Cooper,

British Surgeon

Diabetics and Amputation

“Avoiding amputation is probably the

most important means of reducing

costs and achieving cost effectiveness

in the management of diabetic foot

ulcers.”

Drug Ther Perspect 1998;11(3):13-16

Diabetics and Amputation

Every 30 seconds, somewhere in the

world someone is having a major

amputation for diabetic foot problems!!!!

Every 10 minutes, someone in the

United States is having a major

amputation for diabetic foot problems.

Quote Dr. Andrew Bolton, SAWC, 2011, Dallas, Texas

Arterial Insufficiency and Chronic

Wounds

• ~20% venous ulcer patients have arterial

insufficiency(1)

• 40-55% of diabetic ulcers are ischemic(2)

• In Africa – only 36% of patients with ulcers

have peripheral vascular disease (PVD)(3)

1) Falanga V. Venous Ulceration. J Dermatol Surg Oncol. 1993;19(8):764-771

2) Kerdal FA. Inflammatory Ulcers. J Dermatol Surg Oncol. 1993;19:772-778

3) Ogbera OA, Osa E, et al. Common Clinical Features of Diabetic Foot Ulcers:

Prespectives from a Developing Nation. Int J Low Extrem Wounds 2008;7:93-98

Healing in Patients with Severe

Unreconstructable Vascular Disease

• ABI < .50 and toe pressure < 30

• Could not be revascularized

• Complete wound closure

– 37% at 6 months

– 51% at 12 months

– 66% at 16 months

Major amputation – 15% at 12 months

Wounds 2003;15(12):390-394

Ambulation following

Amputation Of patients ambulatory prior to their amputation:

• BKA

16% ambulated independently

19% required walker

65% unable to walk

• AKA

11% ambulated independently

9% required walker

80% unable to walk Cruz CP, Eidt JF, Capps C, Kirtley L, Moursi MM. Major lower extermity amputations at a

Veterans Affairs hospital. Am Jour Surg 2003;186:449-454

Prepare the Wound for Healing

Wound bed preparation is necessary

to correct the cellular imbalances

present in chronic wounds allowing

the wound to heal or be receptive to

our therapy.

Optimal Wound Bed Preparation

• Maintenance of optimal moisture balance

• Complete debridement of devitalized and poorly functioning tissue

• Restoration of bacterial balance

• Optimize cellular function

• Treatment of edema / lymphedema

Schultz GS, Falanga V, et. al., Wound Rep Reg 2003;11(Supp):1-28

Wound Environment

• Must be kept moist!

• Air-exposed wounds have increased tissue

necrosis and cell death

• Epithelialization is impaired if eschar or

scab remains in place

WOUND DEBRIDEMENT

• Surgically (Sharply)

• Mechanically

• Autolytically

• Enzymatically

• Biosurgically (Maggots)

Effect of Debridement of Chronic

Wounds

• Removes necrotic and ischemic tissues

• Removes infected tissues

• Exposes receptors so that growth factors can get to them

• Removes senescent and non-functioning cells

• Stimulates healing

Debridement

Diabetic Gangrene of Toes with

Abscess of Foot

Diabetic Gangrene of Toes and

Abscess of Foot

Diabetic Foot Ulcer and Abscess

CHRONIC WOUNDS AND

BACTERIA

“All wounds contain bacteria yet few become infected.”

Nancy Stotts, RN, Symposium on Advances in

Skin and Wound Care, 2000

CHRONC WOUNDS AND

BACTERIA

• Contamination – organisms are present on

the wound surface

• Colonization – organisms are present and

multiply on the wound surface

• Infection – organisms invade the tissue and

there is a tissue response

EFFECT OF EDEMA AND

CHRONIC WOUND FLUID 1. Normal anti-Streptococcal properties of skin are

inactivated by edema fluid.

2. Chronic wound fluid inhibits mitogenic activity and DNA synthesis.

3. Cytokine environment in chronic wound fluid is more proinflammatory.

4. Protease activity is higher in chronic wound fluid.

5. Growth factors levels are decreased in chronic wound fluid.

Compression Therapy and

Circulation

ABI Bandage Sub-bandage

pressure (mm Hg)

> 0.8 4-layer 35-40

0.7 2-3-layer 17-25

0.6 2-3-layer 17-25

<0.5 Only with medical

supervision ---

Moffatt C. www.worldwidewounds.com (accessed 1/5/06)

http://www.worldwidewounds.com/

Control Leg Treated Leg

Before

Bandage

With

Bandage

52 47

49 74

ml/min

ml/min

Arterial Flow Pulses

Below Knee Blood Flow via Nuclear Magnetic Resonance

Increased pulses

likely augment

Lymph/venous

transport Dr. HN Mayrovitz, Univ of Miami

Proteases and Compression Therapy

Marston WA, Beider S, Davies S, Berndt DF. Protease and Cytokine Levels in Non-Healing Venous Leg

Ulcers Before and After Compression Therapy. Presented at Symposium on Advanced Wound Care/Wound

Healing Society Meeting, San Diego, CA. April 25, 2008

Inflammatory Cytokines and

Compression Therapy

Marston WA, Beider S, Davies S, Berndt DF. Protease and Cytokine Levels in Non-Healing

Venous Leg Ulcers Before and After Compression Therapy. Presented at Symposium on

Advanced Wound Care/Wound Healing Society Meeting, San Diego, CA. April 25, 2008

Need to Optimize the Wound

Environment

• Compression therapy

• Can be done with doxycycline*

• Can be done with protease modulating

matrix products, Promogran and Prisma

• Can be done with protease reducing agent,

Tegaderm Matrix

*Chin GA, Schultz GS. Wounds 2003;15(10):315-323

Wound Bed Preparation with Prisma:

Apligraf and Diabetic Foot Ulcers

66%

68%

70%

72%

74%

76%

78%

80%

No Prisma

Prisma

(Unpublished data: Institute for Advanced Wound Care, 10/05 – 3/06)

Diabetic Foot Ulcers Healed 12 Weeks Following Apligraf

OK!!!

Now What????

Falanga V, Moneta G. Vasc Surg. 1999; 33:197-210.

Falanga V, Sabolinski ML. Wounds. 2000; 12:42A-46A.

Sheehan P, et al. Diabetes Care. 2003;26(6):1879-1882.

Use of Advanced Technology in

Wound Healing

• Healing rates at 4 weeks predict

overall healing rates

• Initial healing rates of >0.1

cm/wk correlate with healing

• Rapid identification of patients

unlikely to respond to

conventional care will allow for

earlier interventions with

advanced therapies

0.0

2.0

4.0

6.0

8.0

10.0

12.0

4/2

4/8

4/1

4

4/2

0

4/2

6

5/2

5/8

Graph wound

area, length,

width, depth

DERMAGRAFT

APLIGRAF

APLIGRAF®

(Graftskin) Human Skin

Photomicrographs of hematoxylin-eosine-stained cross-sections of APLIGRAF® (left) and human skin (right) 250.

HISTOLOGIC COMPARISON

Stem Cells

• Master cells of the body

• Can divide an infinite number of times

Human Skin and Related Structures

Stem Cells in Apligraf

• Epidermal stem cells present in

Apligraf after manufacturing

• Epidermal stem cells detected in

wounds 8 weeks post application of

Apligraf

Carlson M, Faria K, Leman J, et al. Epidermal Stem Cells Are Preserved During

Commercial Scale Manufacturing of a Bilayered, Living Skin Substitute (Apligraf)

Utilized for Chronic Wound Repair, Wound Rep Reg 2009:17(2):A27. Data presented

at Wound Healing Society Meeting, Dallas, Texas, 2009

What Evidence Is There That

These Products Work?

FDA Product Indications

Apligraf Dermagraft Regranex Oasis Integra

DFU Yes Yes Yes

VLU Yes

Other

WOUND BED PREPARATION

Wound Bed Preparation with

Apligraf

1 month of hydrogen peroxide,

Bactroban, and whirlpool

71 y/o man who

dropped a tree

limb on his leg 1

month prior

Apligraf applied 4 weeks prior

to stimulate wound bed

Wound Bed Preparation with

Apligraf

Wound

Healed 10

Weeks Post

Application

of Apligraf

DIABETIC FOOT ULCER

Pre Apligraf

DIABETIC FOOT ULCER POST APLIGRAF

First Dressing Change 28 days post Apligraf

at 5 days post Apligraf

DIABETIC FOOT ULCER

3 MONTHS POST APLIGRAF

DIABETIC HEEL ULCER

Heel ulcer before Heel after debridement

debridement

DIABETIC HEEL ULCER

APPLICATION OF APLIGRAF

DIABETIC HEEL ULCER

16 WEEKS POST APLIGRAF

IV Infiltration Injury of Foot


6 Weeks Post Apligraf 16 Weeks Post Apligraf


Wound Healed – 20 weeks Post Application of Apligrf

Venous Ulcer

Venous Ulcer

8 weeks post application Healed at 33 weeks

Venous Ulcer

99 year old lady

with ulcer for 8

months. Started

as a scratch on

ankle. ABI-.45

Informed that BK

amputation was

the only therapy.

Venous Ulcer

Wound healed after

47 weeks.

Required 2

applications of

Apligraf. Patient is

now 100 years old

and happy to have

a leg with no ulcer!

“REAL WORLD” USES of

Bilayered Tissue Engineered Skin

for Limb Salvage

Wound of Ischemic Foot

77 y/o gentleman with

severe limiting

claudication of left foot.

No history of diabetes.

Had attempted dorsalis

pedis bypass graft 5 mo.

prior to being seen. Distal

surgical incision broke

down. Was referred for

amputation.


After treating infection

and debriding

8 weeks after

application of Apligraf


Wound healed

32 weeks after

1st application

of Apligraf.

2 applications

required

Pressure Ulcer of Ankle Due to Cast

88 y/o lady with fracture of ankle treated with cast

Pressure Ulcer of Ankle

Open Joint

8 Weeks Post Debridement

Apligraf applied


2 Weeks Post Application of Apligraf


9 Months Post First Application

7 Months Post Second Application

Limb Salvage:

The Wound Center Perspective

Comments we DO NOT

want to hear

I normally wouldn’t

recommend an

amputation but that

wound will never heal

anyway.


recommend an

amputation but you are

going to lose your leg

someday anyway so we

might as well do it now.


recommend an

amputation but that is all

I know to do for your

wound.


recommend an

amputation but I don’t

want to mess with your

problem any more.

“It’s what you learn

after you know it all

that counts.”

John Wooden,

Legendary basketball coach at UCLA

“It’s kind of fun to do

the impossible.”

Walt Disney

limb salvage: the wound salvage the wound center...in the management of diabetic foot ulcers.”...

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