Week 1 of Diabetic Wound Evidence Based Treatment

1. Relieve Pressure                              Offloading Devices
2. Manage Infection                            Antimicrobials
3. Remove Callus                                  Debride Callus
4. Remove Avascular Tissue             Debride Non-Viable Tissue
5. Optimize Nutrition                          Glucose Control
6. Protect Surrounding Tissue         Barrier Paste
7. Control Moisture                             Absorbent dressing

Week 4 of Diabetic Wound Evidence Based Treatment: If the diabetic foot ulcer heals less than 50% over the first 4 weeks* then consider the following adjunctive therapies or treatments:

1. Assess Circulation                            T-com study
2. Sponsor Granulation                      NPWT
3. Introduce  Growth Factors           Skin Substitute / Regranex
4. Improve Microcirculation             Hyperbaric Oxygen Therapy (Wagner 3 or Greater Diabetic Wounds)

20 Week Diabetic Wound Benchmark: 67% of diabetic foot ulcers remain unhealed after 20 weeks of care¹.

*Note: “50% percentage area reduction at four weeks was significantly associated with healing at 12 weeks”².

1. Kantor J, Margolis DJ. Expected healing rates for chronic wounds. WOUNDS. 2000;12(6):155-158.

2. Snyder R, Kirsner R, Warriner R, Lavery L, Hanft J, & Sheehan P, 2010. Consensus Recommendations on Advancing the Standard of Care for Treating Neuropathic Foot Ulcers in Patients with Diabetes. Ostomy Wound Management. 2010;56 (suppl 4):S1-S24.

Total Contact Casts are typically intended for diabetic planter ulcers.

Hold or don’t initiate a Total Contact Cast if:

1. Infection
2. Critical limb ischemia Tcom < 30mmHg
3. Major illness / Unstable patient
4. Frail / Bad hip or back
5. Non-compliance (overactive)

Quick Fixes for Total Contact Cast Complications:

1. Heavy Drainage – Biweekly changes
2. Toe Drainage – Open toe cast
3. Discomfort – Add padding
4. Chafed skin -  Add padding
5. Pre-ulcerated lesion on pressure point – offload pressure point
6. New ulcer – offload pressure point

Consider a DH Walker if you are unable to control for:     

1. Discomfort with extra padding
2. Chafed skin with extra padding
3. New ulcer formation continues regardless of offloading
4. Lower extremity joint problems

Note: DH Walkers are hard to ambulate in for patients with a weak gait. If this is the case consider a walker. If it is still difficult for the patient to ambulate consider a wedge shoe (Darco).

Note: Consider a Crow Boot for patients who have a rocker bottom (Charcot) foot deformity.

Diabetic Etiology 20 week of healing benchmark

Research indicates that 67% of diabetic foot ulcers remain unhealed after 20 weeks of care. (Note: Average healed at 20 weeks is 33%)

Kantor J, Margolis DJ. Expected healing rates for chronic wounds. WOUNDS. 2000;12(6):155-158

RESULTS—Wound area measurements at baseline and after 4 weeks were performed in 203 patients. The midpoint between the percentage area reduction from baseline at 4 weeks in patients healed versus those not healed at 12 weeks was found to be 53%. Subjects with a reduction in ulcer area greater than the 4-week median had a 12-week healing rate of 58%, whereas those with reduction in ulcer area less than the 4-week median had a healing rate of only 9% (P < 0.01). The absolute change in ulcer area at 4 weeks was significantly greater in healers versus nonhealers (1.5 vs. 0.8 cm2, P < 0.02). The percent change in wound area at 4 weeks in those who healed was 82% (95% CI 70–94), whereas in those who failed to heal, the percent change in wound area was 25% (15–35; P < 0.001).

Percent Change in Wound Area of Diabetic Foot Ulcers Over a 4-Week Period Is a Robust Predictor of Complete Healing in a 12-Week Prospective Trial Peter Sheehan, MD1,Peter Jones, MSC2,Antonella Caselli, MD3 John M. Giurini, DPM3 and Aristidis Veves, MD3

10.2337/diacare.26.6.1879 Diabetes Care June 2003 vol. 26 no. 6 1879-1882

Nutrition

“Basic principles of nutritional management of a patient with diabetes mellitus to control glucose, hyperlipidemia, and hypertension should be applied to the patient who has developed neuropathic foot ulcers.”

Level of Evidence=C

WOCNS, 2004. Guideline for Management of Wounds in Patients with Lower-Extremity Neuropathic Disease. Pg. 24

Offloading

“Ensure adequate offloading of pressure through wound closure. Utilize assistive devices to provide support, balance, and offloading of the affected site.”

Recommendation

WOCNS, 2004. Guideline for Management of Wounds in Patients with Lower-Extremity Neuropathic Disease. Pg. 17

TCOM

A transcutaneous oxygen monitor study “is indicated to assess tissue perfusion when the lower extremity wound is not healing or an ABI or toe pressures can not be done due to incompressible arteries” (Grolman et.al. 2001: Hopf et al., 2006: Stalc & Poderos, 2002).

Level of Evidence = A

WOCNS, 2008. Guideline for Management of Wounds in Patients with Lower-Extremity Arterial Disease. Pg. 14

Negative Pressure Wound Therapy

Negative Pressure Wound Therapy  “has been demonstrated to be effective for the treatment of neuropathic/diabetic ulcers and skin graft and donor sites.”

Level of Evidence = B

WOCNS, 2004. Guideline for Management of Wounds in Patients with Lower-Extremity Neuropathic Disease. Pg. 27

Skin Substitutes

Skin Substitutes have the potential to stimulate, through topical activation the normal or enhanced activity of mechanisms involved in tissue repair.

(Gentzkow, Iwasaki, Hershon, Mengel, Prendergast, Ricotta et al., 1996; Gentzkow, Jensen, Pollak, Kroeker, Lerner, Lerner et al., 1999; Marston, Hanft, Norwood & Pollak, 2003)

Level of Evidence = 1b

Hyperbaric

“Hyperbaric oxygen therapy may be clinically effective in treating patients with limb-threatening diabetic wounds of the lower extremity (Wagner grades III and IV)

Level of Evidence = A

WOCNS, 2004. Guideline for Management of Wounds in Patients with Lower-Extremity Neuropathic Disease. Pg. 27

Grade I-A: non-infected, non-ischemic superficial ulceration

Grade I-B: infected, non-ischemic superficial ulceration

Grade I-C: ischemic, non-infected superficial ulceration

Grade I-D: ischemic and infected superficial ulceration

Grade II-A: non-infected, non-ischemic ulcer that penetrates to capsule or bone

Grade II-B: infected, non-ischemic ulcer that penetrates to capsule or bone

Grade II-C: ischemic, non-infected ulcer that penetrates to capsule or bone

Grade II-D: ischemic and infected ulcer that penetrates to capsule or bone

Grade III-A: non-infected, non-ischemic ulcer that penetrates to bone or a deep abscess

Grade III-B: infected, non-ischemic ulcer that penetrates to bone or a deep abscess

Grade III-C: ischemic, non-infected ulcer that penetrates to bone or a deep abscess

Grade III-D: ischemic and infected ulcer that penetrates to bone or a deep abscess

Lavery LA, Armstrong DG, Vela SA, Quebedeaux TL, Fleischli JG. Practical criteria for screening patients at high risk for diabetic foot ulceration. Arch Intern Med. 1998 Jan 26;158(2):157-62.

This product is indicated for offloading planter digit, planter metatarsal, medial metatarsal, lateral metatarsal, charcot midfoot  and heel wounds.

Removable Cast Walker/ Walking Boots
1. Charcot Restraint Orthotic Walker  (CROW) boot:
This product is indicated for offloading planter digit, planter metatarsal, medial metatarsal, lateral metatarsal, charcot midfoot,  and heel wounds.
2. DH Walker (also known as Active Offloading Walker):
This product is indicated for offloading planter digit, planter metatarsal, medial metatarsal, lateral metatarsal, charcot midfoot,  and heel wounds.
3. Prefabricated Walker (any premade walking boot):
This product is indicated for offloading planter digit, planter metatarsal, medial metatarsal, lateral metatarsal, ankle, and heel wounds.
4. Patella Tendon Bearing (PTB) brace:
This product is indicated for heel wounds.

Wedge Shoes
1. Darco Wedge Shoe:
This product is indicated for offloading planter digit, planter metatarsal, medial metatarsal, and lateral metatarsal wounds.
2. Ortho Wedge Shoe:
This product is indicated for offloading planter digit, planter metatarsal, medial metatarsal, and lateral metatarsal wounds.
3. Darco Reverse Wedge Shoe:
This product is indicated for offloading heel wounds.

Multipodus Splint / Boot (Prafo, L’nard, Bend-a-boot, Multiboot):
This product is indicated for offloading heel and ankle wounds.

Surgical Shoes or Shoes with Pressure relief Insoles
1. Post op shoe (e.g. the Darco med-surg shoe with “peg assist”):
This product is indicated for offloading dorsal digit wounds.
2. DH Pressure Relief shoe (also the DH offloading post-op shoe):
This product is indicated for offloading planter digit, planter metatarsal, medial metatarsal,  lateral metatarsal wounds, and ankle wounds.
3. Plastizote Healing Shoe:
This product is indicated for offloading the dorsal digit, planter digit, planter metatarsal, medial metatarsal, lateral metatarsal, and heel wounds.

Diabetic wounds are related to microvascular and neuropathic changes in the diabetic patient. Diagnosis of the diabetic ulcer includes a compatible history of diabetes, monofilament test (to assess for loss of sensation), and noninvasive vascular assessments including a transcutaneous oxygen monitoring (TCOM) study. Treatment options for diabetic ulcers include off loading, growth factors (Regranex), debridement, and skin substitutes (Apligraf and Dermagraft).

Diabetic wounds place patients at high risk for infection including osteomylitis. Diabetics can also suffer from gangrenous wounds (see photo).  Because of these risks approximately 15% of Diabetic Foot Ulcers result in lower extremity amputation (2).    Though 40% to 50% of all diabetes-related amputations are preventable (1) .   Foot-care programs for diabetics (including teaching self foot assessments)  have been shown to reduce the rate of ulcers and amputations by 45% to 85% (1).

1. Garcia – Diaz, J., Pankey, G., & Gentry, Layne., 2006. The contemporary Diagnosis and Management of Diabetic Foot Infections. Health Care Co., Newtown, Pennsylvania. pg.16

2. Snyder, R., Kirsner, R., Warriner, R., Lavery, L., Hanft, J. and Sheehan, P., April 2010. Consensus recommendations on advancing the standard of care for treating neuropathic foot ulcers in patients with diabetes. Supplement to April 2010 OWM, S4.

Diabetic Wound Related  Terms:

Diabetic (Neuropathic) Ulcer – Sensory neuropathy involving the feet may lead to unrecognized episodes of trauma caused by ill-fitting shoes or walking barefoot. This is compounded by motor neuropathy causing intrinsic muscle weakness and spaying of the foot on weight bearing. The result is a convex foot with a rocker-bottom appearance. Multiple fractures go unnoticed, until bone and joint deformities become marked. This is termed a Charcot foot (ie, neuropathic osteoarthropathy) and is observed most commonly in people with diabetes mellitus, affecting approximately 2% of persons with diabetes.

Diabetes: The long-term effects of diabetes impair wound healing by diminishing sensation and arterial inflow. In addition, even acute loss of diabetic control can affect wound healing by causing diminished cardiac output, poor peripheral perfusion, and impaired polymorphonuclear leukocyte phagocytosis.

DIABETIC ULCER – An ulcer that develops due to diabetic risk factors. Diabetes affects circulation as well as the nerve endings in the feet. As a result, many diabetics suffer reduced circulation and loss of sensation in their feet. The loss of sensation is dangerous, because diabetics are unable to feel rubbing, pinching or other pain that could cause a wound to develop on the foot. Lack of circulation to the feet makes it very difficult for a wound to heal. Risk factors for developing a diabetic foot ulcer include loss of sensation or peripheral neuropathy, structural foot deformity, infection, and decreased circulation.

Charcot Foot (Arthropathy) –Acute- Foot deformity with sudden onset of swelling,
increased local skin temperature, erythema, rapid joint changes, looseness of ligaments,
dislocation and fractures without apparent cause.

Charcot Foot (Arthropathy -Chronic -progressive degeneration of the stress-bearing
portion of a joint, with hypertrophic changes at the periphery. It is manifested by rapid
joint changes, looseness of ligaments, dislocation and fractures.

HgbA1c – Glycated hemoglobin, also known as glycohemoglobin, glycosylated hemoglobin, HbA1c or HbA1, refers to a series of stable hemoglobin components formed by the combination of glucose and hemoglobin. Individuals with higher levels of blood glucose will have higher levels of glycated hemoglobin. Because the hemoglobin
components are stable, the level provides an average indication of the overall blood glucose levels over the prior two to three month period. The most commonly used version of the glycated hemoglobin test is the HbA1c.

Hyperkeratotic – Hypertrophy of the horny layer of skin and often appears as a callus ring around a diabetic wound.

Monofilament Test or Semmes Weinstein Monofilament Test  – Is a sensory exam of the foot to detect sensory neuropathy – a 10 gram monofilament
which is pressed to several sights on the feet for 1.5 seconds on each sight and the patient is asked to say “yes” when the monofilament is felt.

Orthotics – a full contact semi rigid, soft insert designed to redistribute pressure, reduce impact, shear and stabilize involved joints. A suitable prescription should include a
complete diagnosis, reflecting the risk category of the patient. Orthotics must be casted and fitted appropriately by an experienced professionally trained clinician.

Osteomyelitis – Inflammation of bone and marrow, usually caused by infection.

Gangrene- Death of cells with the appearance of a dessicated or shriveled tissue area related to poor perfusion.