Advances in

healing of
diabetic
ulcers
J. Palmer Branch, DPM
Comprehensive Foot and Ankle, LLC
www.comprehensivefootandankle.net
DrCuboid@aol.com
Lilburn, GA (770-921-8800) Cumming, GA (770-886-6833)

Overview Key questions

-

Why do we care? / What is the problem?

- Demographics
- Costs
- Healthcare expenses
- Personal costs / debilitation

Why are diabetic patients at risk for foot ulcers?

What happens in the normal healing process?

Why do diabetic patients not heal as well as non-diabetics?

How do you examine the wound for potential problems?

What can be done to enhance / expedite the healing process?

- What types of advanced treatments and products are available?
- When should advanced treatments be used?

How can recurrent diabetic ulcers be prevented?

Overview Additional comments

Recent advances in treatments for diabetic foot wounds have:
Allowed the ability to heal limbs previously thought to be
unsalvageable (e.g. Interventional arteriography / arterial
stenting)
Enhanced the variety of treatment options to better
individualize care for each situation and wound.
Provided a better recognition of the wound healing process.
Reduced the healing time
Reduces risk of infection less window of opportunity
Can reduce overall treatment cost
3

Demographics - USA
In the US Diabetes has reached epidemic
proportions
Over 16 million people diagnosed with
diabetes
8 million estimated undiagnosed
15% of all diabetics will have a foot ulcer at some
point in their lives
PAD risk 2-6 times greater in diabetics.
6% of all diabetics undergo amputation
75% of all diabetic amputations are preventable
Increased 5 year mortality rate (18 to 55%
higher in ischemic ulcers)
4

Costs of diabetic limb amputation

Costs average cost per amputation over $40,000
(Surgeon procedure fees only $750 1200)
Estimated Cost - diabetic amputations in US $1 billion
(2007)
Medical cost factors:
Hospitalization
- Home nursing
Surgical procedures- Skilled nursing facilities
Prosthetic limbs
- Recurrent problems
Other cost factors
Lost wages short-term and long-term
Lost income tax revenues to federal / state / local government
Dependence on public assistance Medicaid, Social Security
Depression, despondency, disruption of family. 5

Cardiac disease and foot ulcers

Increased cardiac workload after partial foot or leg
amputation should not be quick to do this.
Cardiovascular disease has been found to be
increased by amputation alone in populations not
controlled for diabetics.
Modnay & Peles -21.9 % vs. 12.1% over a 21-year
time period in lower extremity traumatic amputees in
military veterans
Question not answered well in literature: Is the increase
in mortality from cardiac disease due to inactivity vs.
the cardiac strain or some combination of factors?
6

Risk factors for impaired wound healing

PAD (peripheral arterial disease) 2-6 times more prevalent in DM.
Neuropathy lack of protective sensation, motor imbalance
Immunocompromised status
Structural problems focal pressure sites
Contractures of toes, bunion deformities
Equinus contractures tightness of the Achilles tendon
Charcot joint / arthropathy
Other health factors
7

PAD and wound healing

The threshold circulation necessary for wound healing
in the diabetic foot is systolic toe pressure 3045mm Hg or ankle pressure 50-80mm Hg (ABI
0.40 0.66)
Arteriosclerosis in diabetics can cause
noncompressible arterties leading to falsely
elevated pressures on lower extremity arterial
Doppler evaluation.
TcPO2 of 30mm Hg also mentioned frequently as a
threshold value for wound healing.
8

Consider not only the quantity of

blood getting to the wound, but
also the quality of the blood.
Evaluate for systemic factors
anemia (CBC with differential)
hypovolemia
malnutrition (albumin/prealbumin, total protein)
hyperglycemia
9

Causes of ulcers - Neurologic

Loss of protective sensation (LOPS)
Motor imbalances Dropfoot and other motor function
alteration
Autonomic neuropathy
Charcot Arthropathy / Charcot Joint

10

Venous Ulcers
Venous
- Lack of return of venous blood to the heart
- Fluid buildup / edema in the legs
- Skin necroses due to underlyling venous pressure
and buildup of waste products produces an
ulceration.
- Stasis dermatitis often noted in chronic cases
- Compression a key to treatment

11

Evaluation of the diabetic ulcer

12

Evaluation of the diabetic ulcer

Size length, width and depth
Probe to bone or visible bone
clinical osteomyelitis
Grayson - 75 patients, 76 ulcers
Sensitivity of 66% for osteomyelitis
Specificity of 85%
Positive predictive value of 89%
Negative predictive value of 56%.

13

Evaluation of the diabetic ulcer

Cellulitis not always present in patients with PAD or
immune compromise
Wound base quality eschar, granular, fibro-fatty
Malodor
Surrounding skin and wound margins

14

Evaluation of the diabetic ulcer

Location
Abscess
visible or palpable
tissue crepidus
Drainage type
Purulent vs. serous
Amount Healthy granular tissue normally has mild to moderate
drainage.
Heavy drainage may have venous and/or infectious
component
Little to no drainage may have ischemic component
15

Ulcer associated with brown

recluse spider bite, skin
necrosis, underlying abscess

Digital ulcer in diabetic with PAD,

ischemic base, atrophic skin

16

Radiographic / Imaging for infection

X-rays
osteomyelitis (bone erosions, periostitis)
soft tissue gas
MRI
Useful if X-rays not definitive
Nuclear Medicine
3 phase bone scan more sensitive than plain X-rays for
osteomyelitis, less specific
Often false positive with Charcot joint, Arthritis, fracture,
recent injury, recent bone surgery (6 or more months)
Labeled scan (Indium, Gadolinium, Ceretec) may be more
specific

17

Classifications of diabetic ulcers

Wagner most commonly used and recognized.
Stage 0 - No active ulcer, but risk factors present (pre-ulcerative
callous, history of foot ulcer, foot deformity)
Stage 1 - Superficial ulcer , to subcutaneous fat.
Stage 2 - Ulcer to tendon, ligament, joint capsule, or deep
fascia, no major abscess
Stage 3 - Ulcer to bone (or deep abscess)
Stage 4 - Ulceration with forefoot ischemia.
Stage 5 - Ulceration with ischemia of entire foot.

University of Texas San Antonio

Others
18

Basics of
wound
healing

General principles of good wound care

KISS principle (Keep It Simple, Stupid)
Be sure to not overlook the obvious
Evaluate and treat infection if present fully
Removal of nonviable and infected tissue when possible
In osteomyelitis, all infected bone should be removed
See if the wound will rapidly respond to simple, basic
treatments.
If it isn t broken, dont fix it.
Continue basic treatments and regular observation.

20

Treatments / wound care

Traditional products
Saline, betadine, gauze, etc.
Pressure relief
Braces (e.g. Podus boots)
Pillows
Ambulatory bracing

21

Other wound care products

Chemical debriders
Unna boots, multi-layered compression wraps
Leg compression pumps
May be helpful with venous ulcers
Debriding / wound lavage instruments
Pulse lavage
Ultrasonic and hydrosurgical debriders

22

PAD treatments
Medical treatment for PAD

Plavix inhibits platelet aggregation

Pletal inhibits platelet aggregation and provides
vasodilation
Contraindicated in CHF.

Trental enhances platelet flexibility, full effects 90-120

days

Topical Nitroglycerin (nitroglycerin ointment, Nitrodur

patches)
Provideslocalized vasodilation - increases wound
perfusion.
Helpful particularly in cases where limb perfusion cannot
be enhanced by vascular intervention.
23
Have to be cautious of hypotension particularly
in elderly

Surgical procedures - traditional

Incision and drainage / surgical debridement

The solution to pollution is dilution.

Removal of infected / nonviable tissue.
All infected bone in osteomyelitis should be removed.

Amputation levels
BKA/ AKA goal is to avoid
Symes, Choparts, Transmetatarsal, LisFrancs
Digital partial or complete

Surgical Wound closure / coverage

Flaps (Advancement, rotational)
Skin Grafts
Other complex wound
24

Surgical procedures -Amputations

Considerations in amputation selection level
Vascular supply
- Is it adequate for healing?
- Is the patient a candidate for revascularization?

Consider how the limb and patient will function

Nonambulatory patients may be better served with a more proximal
amputation
Patients with otherwise impaired isolated limb function need individualized
consideration
Dropfoot
Flexion Contracture

Preservation of as much of a functional limb as possible.

- Decreased cardiac workload
Plan bone and soft tissue resection and closure carefully to prevent further
problems
25

Advanced
treatments and
products
26

Newer wound dressings

Advanced wound dressings more absorbent, hydrating, and/or
antimicrobial than gauze
Alginates very absorbent (e.g. Fibracol)
Hydrogels maintain optimal wound hydration,
Silver antimicrobial vs. MRSA contamination / colonization
Silver alginates e.g. Acticoat rope
Silver Hydrogels e.g. Silvasorb, Aquacel Ag
Silver sheet dressings e.g. Acticoat
Honey
Collagen dressings (Promogran) release collagen into wound
base which is helpful in wound healing.

27

Topical - Growth Factors

Stimulate the healing process
Dermagraft Vicryl sheet with Fibroblasts

Apligraf similar product bilayered absorbable mesh with

keratinocytes on one layer, fibroblasts on the other.

Regranex Topical gel with smaller amounts of growth factors.

Procuren - Older product
Future Stem cell-derived products, Additional bilayered skin
equivalents

28

New surgical products - scaffolds

GraftJacket, Alloderm
- Freeze-dried human dermis
- Provides a collagen scaffold for ingrowth of granulation tissue
Brigido - Compared single application of GraftJacket to sharp
debridement, weekly dressing changes - 85.7% healed with
GraftJacket at 12 weeks vs. 28.6% healed at 12 weeks
without.
Integra dermal replacement, bilayered allows for ingrowth of
new skin
Oasis Porcine intestinal subucosa
Pegasus (OrthoAdapt) equine pericardium
Rejection a possibility

29

SCAFFOLD CONCEPT
HEALING TISSUE GROWS
INTO THE GRAFT GRAFT
REPLACED WITH
PATIENTS OWN TISSUE
OVER TIME

GraftJacket Sample case

After debridement

Infected wound dehiscence ulcer

6 weeks s/p I & D, & IV antibiotics

GraftJacket applied in OR
(Osteoset antibiotic beads and
VAC also used.)
31

GraftJacket Sample case

1 week post-op

2 weeks post - op

Osteoset absorbable antibiotic beads also noted

8 weeks post-op

Wound healed around 16 weeks

post - op

32

Advanced treatments and products

Negative pressure therapy suction devices
Eliminates wound exudate
- Waste products from tissue can be toxic to healing
- Prevents maceration
Can reduce wound volume by suction effect
Enhances capillary ingrowth
Daily dressing changes not necessary 1-2 times a week.
Classic article Morykwas and Argenta, 1997.
Also frequently used with split-thickness skin grafts and freezedried dermis grafts to enhance adherence of the graft to the
wound base.

33

Business
Template

34

Hyperbaric Oxygen
Mechanisms of action: wound healing is enhanced by increased
fibroblast proliferation, increased collagen production, increased
capillary angiogenesis, and release of growth.
100% oxygen in a pressurized full-body treatment chamber
Usually pressurization should be at least 1.4 atm abs (usually 2
2.5 atm abs)
Can enhance wound healing, particularly in debilitated patients

Effects on the oxygen saturation of the blood may be

more important that local effects on the wound.
Useful in infections antimicrobial effects, particularly in
anaerobic infections (bacteriostatic), osteomyelitis

35

Advanced Treatments When to use

If the wound is not responding well to traditional

care
Sheehan - 203 patients (prospective, randomized) study

Median healing percentage at 4 weeks was 53%

-If > 53% healed @ 4 weeks, then 58% chance of
full
wound healing at 12 weeks
-If < 53% healed, then only 9% were healed at 12 weeks.
Conclusion if not 53% healed at 4 weeks, then additional
care needed.

Anticipated difficulty in healing / high complication

potential
Size/ depth Anatomic Location

Patient risk factors

Cost-Effectiveness Considerations: Is the potential

cost of not doing something more aggressive going to be
more expensive than the cost of the advanced therapy?
36

Questions to ask when considering

advanced and / or new treatments
Are there other treatable reasons the ulcer is not
healing?
Infection adeqaute medical and surgical treatment
Vascular supply is it adequate or can it be
improved?
Patient factors - (overall health, noncompliance, etc.)
Pressure relief offload the wound site
Would additional consults be appropriate?
Is there adequate evidence based medicine that the
treatment or product is effective, particularly for the
situation?
37

Selection of appropriate
advanced therapy
How can the healing process be best enhanced for
the ulcer?
Applying medical expertise and judgment to each situation
Medicine is often more an art than a science.

Know what each product can do particular indications

and benefits of each device or treatment.

Are there any reasons why advanced treatments

cannot be used in the situation?

38

The Healed Diabetic Foot What next?

Crane M, Branch P. Clin Pod Med Surg.
v. 15, n 1, Jan 1998, p. 155-74.

39

Prevention of diabetic foot ulcers

Education
risk of foot ulcers and importance of early treatment.
Patients should examine their feet daily
Annual foot exam - more frequent if high ulcer risk (previous
ulcer,neuropathic, PAD).
- Diabetic neurologic evaluation (PQRI #G8404)
- Evaluation for appropriate diabetic foot wear (PQRI #G8410)
Recommended by the American Diabetes Association as well as
annual eye exam.
relative risk for ulceration

40

Diabetic Nail and Callous care

Prevention / early treatment of ingrown nails and preulcerative callouses
Prevention of patients cutting the skin when cutting their
own nails

41

PAD Follow-up
Follow-up for progressive PAD
Clinical exam
Arterial ultrasound
Ensure maintenance of adequate vascular
status.
Particularly important after vascular intervention
(stenting, bypass, etc.) to examine for patency of
the treated arteries.

42

Protective devices for foot ulcer prevention

Custom Braces
AFO (Ankle Foot Orthosis)
Dropfoot braces
Rigid AFO for severe flatfoot or other deformities
Patellar Tendon brace shifts some pressure to patellar tendon
Protective shoes
Extra Depth shoes with custom molded protective foam insoles
to balance pressure
Custom Molded shoes made from a plaster mold of the
patients foot
Commonly used in severe foot deformities e.g. Charcot
Rocker-bottom foot
43

Diabetic shoes - Characteristics

Medicare Therapeutic Shoe Bill covers protective shoes for
diabetics annually.
Also covered by many private insurers and Medicaid providers
Extra-depth shoes vs. True Custom-molded shoes
Documented success
CDC has proven that they reduce the incidence of foot
amputation
In patients with a history of foot ulcers, 80% without diabetic
shoes, 20% with properly fitted protective diabetic shoes.
At minimum are cost-neutral
Should be professionally fitted by individuals with proper
training
(DPM, C Ped, CO)
44

Elective surgical procedures

Surgical intervention
For pain and/or ulcer prevention from foot deformities
Conservative measures should be exhausted first
Example elective minor procedures

Hammertoe and Bunion correction

45

Elective surgical procedures

Tendon lengthening or tenotomy procedures for
contractures
Exostectomy procedures (reduction of bony
prominences)
Reconstructive surgery (e.g. Charcot joint
reconstruction / realignment)
Should be only as a last resort and undertaken with
great caution and careful patient selection.
Patient MUST be thoroughly evaluated before
surgery for adequate circulation and other risk
factors for wound healing problems.
46

Those who suffer losses due to

diabetes are not just statistics on a
chart. They are people whose talents
and wisdom are needed and whose
problems deserve our unified efforts.
Together we can make life more just
and more joyful for generations to
47
come

THANK YOU

J. Palmer Branch, DPM DrCuboid@aol.com

Comprehensive Foot & Ankle, LLC
www.comprehensivefootandankle.net
48
Lilburn, GA (770-921-8800); Cumming, GA (770-886-6833)

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