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DIABETIC FOOT 2008

SELECTED DIABETIC FOOT, NEUROPATHIC ULCERS CAN BE AMELIORATED AND HEALED BY A COMBINATION OF TOPICAL PRP AND LED (633nm): THE BIOLOGICAL APPROACH

Chronic recalcitrant, sole-of-foot, neuropathic ulcers are a huge challenge to physicians, surgeons, ulcer clinics, diabetologists and vascular surgeons.  In many cases progressive spread of infection into the deep fascial planes of the foot, necessitate surgery, drainage and debridement and even amputation (forefoot, below- and above knee).  This is especially prevalent in Type II diabetics today.  Often co-morbidities exist such as renal failure, cardiac disease, retinopathy, neuropathy, previous amputation and stroke that make rehabilitation of the “diabetic foot” or the amputee challenging.  In these cases a multidisciplinary amputation team is needed with nursing and social service back-up.

CLASSIFICATION OF THE “DIABETIC-FOOT”

  • Ischaemic (macro or microscopic)
  • Septic lesions (superficial or deep).
  • Neuropathic lesions (sensory, motory or “autosympathectomy”)
  • Combination lesions (often the most common)

SITES OF NEUROPATHIC SOLE ULCERS (MALPERFORANS)

  • Over the heads of the metatarsal bones
  • Over bunion area, under pad of big or small toe (3-4 ulcers may co-exist)
  • Lateral aspect/overlying the distal phalanx of the big toe

SOP: TREATMENT OF SEPTIC AND SOLE ULCERATION IN DIABETICS:

See attached table for treatment guidelines approved by most vascular units and ulcer clinics.


SOP: CONVENTIONAL TREATMENT PROTOCOL FOR “DIABETIC FOOT”

  • Classify and grade foot.  Type I, II, III, IV

  • Rule out sepsis: do pusswab and microbiology

  • Rule out spreading cellulitis gangrene

  • Rule out involvement of deep fascial planes and foot compartments

  • Rule out gas in foot (X-ray)

  • Rule out deep tendon involvement: CT or MRI

  • Rue out associated ischaemic lesions

  • Define atherosclerosis grading: arteriogram

  • Rule out septicaemia, renal failure, cardiac failure

  • Define co-morbidities (heart, brain, eyes, kidneys)

  • Define rehabilitation status (? Dyspnoea, ? heart failure)

  • Define degree of neuropathy in feet

  • Define deformities of feet: collapsed foot arches

  • Categorize foot: 1-5 University of Texas scoring

  • Confirm status of glucose control and lipid profile

  • Consider foot soaks to wash out pus and soothe the foot

  • Consider hydrofibre wound dressings to ulcer bed (Aquacel, Granuflex Convatec, Adcock Ingram)

  • Administer appropriate antibiotics (aerobic and anaerobic spectrum according to results of pusswab/micro: drain abscesses

  • Prescribe off-loading shoe ware

  • Control blood sugar: use sliding scale and insulin

  • Appropriate conservative foot debridement, drainage of pus collections.  Conservative amputations initially

NEW BIOLOGICAL APPROACH TO RECALCITRANT NEUROPATHIC DIABETIC FOOT ULCERS

  • Stick to accepted surgical principles:  Sepsis control, antibiotics, off-loading, definition of co-morbidities, conservative debridement and drainage of pus collections, control of diabetes if necessary with insulin and a sliding scale.  Intravenous antibiotics may be needed for septicaemia.  Renal failure is a poor prognostic sign. Continue with Granuflex and Aqaucel dressings.
  • Apply platelet rich plasma (PRP):  Twice daily on weekly basis to ulcer base.  Retention of the PRP is facilitated by the use of Aquacel® dressings.  Autologous PRP used as topical agent is safe.  Six to 8 treatments are needed and the plasma does not burn the ulcer because of associated sensory fall-out, due to diabetic neuropathy.

CONTRAINDICATIONS:  Not suitable if uncontrolled foot sepsis is present or gangrene is poorly managed. First control infection, administer appropriate antibiotics, collect pus swabs, drain pockets of pus under general anaesthesia to prepare granulating surface. Then consider PRP, once bypassable  limb ischaemia or critical ischaemia is ruled out, and infection is brought under control. Osteomyelitis is problematical.

REGENLAB PRP provides:

  • PDGF
  • Transforming growth factor (TGF)
  • VEGF
  • EGF

These growth factors facilitate migration of keratinocytes, improvement of ECM, proliferation of myofibroblasts and pericytes with enhanced deposition of collagen from both cell lines.  Patient visits the practitioner once a week.  16 ml of venous blood is obtained per visit and centrifuged to produce REGENLAB PRP that is activated with calcium chloride 10% before onlay of the platelet gel.

  • Six to 8 treatments of the foot with Omnilux LED 633 nm athermal light to reduce inflammation in the foot and to facilitate wound healing.  Duration of foot exposure, 20 minutes, with no down-time.  This combination treatment is given: PRP/factors topically ( biological approach) and LED irradiation (bimodal, complementary treatment).  Visible red light at wavelengths from 630 to 700 nm penetrates tissue to a depth of about 10mm.  There are no adverse side effects “cell function enhancement” is facilitated by photomodulation.

Increased collagen synthesis/deposition can be expected together with fibroblast proliferation (macrophages, myofibroblasts and mast cells).  Also, chemotaxis and phagocytic activity of leucocytes and macrophages are enhanced through cellular stimulation by their wavelength.  Lee et al 2007 of Korea has also documented the biological effects of LED phototherapy for skin rejuvenation.

  • Activation of dermal fibroblasts
  • Increase in TIMP-1 and 2
  • mRNA levels of IL-1b, TNF-α, ICAM-1 and Cx43 increase after LED photolight therapy
  • Decrease in IL-6

Examples of LED + PRP for diabetic foot ulcers is provided.



Five shallow neuropathic ulcers in an insulin-dependant Type-1 diabetic, treated with LED and platelet rich plasma (PRP). End-point analysis was closure of ulcers. 75% closure at 4 weeks by biological wound care.



Biological or advanced wound healing technology showing almost complete ulcer closure a 4 weeks with weekly treatment of PRP and LED.



Complete ulcer closure by the application of PRP and LED at 6 weeks. Treatment included application of off-loading shoe-ware. Patient  rendered ambulant from wheel-chair situation by biological wound care technology.



Healed wound protected with MOLESKIN and facilitates ambulation and weight bearing.

ACADEMIC REFERENCES DIABETIC FOOT ULCERATION

    • Du Plessis DJ.  Principles of Surgery.  A new approach. John Wright and Sons, Bristol, 1968: 155.
    • Schwartz SI et al.  Principles of Surgery, McGraw Hill, New York, 1999: 223-236.
    • Kumar V et al.  Robbins Basic Pathology, Saunders, Elsevier, 2007: 59-79.
    • Du Toit DF.  cellulose Diabetic Foot.  Essensiële Chirurgie.  Teorie en Praktyk.  Mainline, Kaapstad, 1991: 180-184.Piaggesi A et al.  Sodium carboxyl-methyl- dressings in the management of deep ulcerations of diabetic feet.  Diabetes UK.  Diabetic Medicine, 2001; 18: 320-324.
    • Brunner U et al.  Experiences with hydrofibres in the moist treatment of chronic wounds, in particular of diabetic foot.  VASA, 2000; 29: 253-257.
    • Marx RE, Gearg AK.  Dental and Craniofacial Applications of Platelet-Rich Plasma.  Quintessence Books, Chicago, 2005: 5-30.
    • Du Toit DF et al.  Shoulder surgeon and autologous cellular regeneration – From bench to bed: Part – 1 – the link between the human fibroblast, connective tissue disorders and shoulder. IJSS 2007; 1: 87-95. ( www. Internationalshoulderjournal.org).
    • Du Toit DF et al.  Soft- and hard tissue augmentation with platelet-rich plasma: tissue culture dynamics, regeneration and molecular biology perspective.  IJSS 2007; 1: 64-73. (www.internationalshoulderjournal.org).
    • Du Toit DF et al.  State-of-the-Art rejuvenation and wound healing with platelet rich plasma growth factors.  Part 1 and 2.  The Specialist Forum 2007; 7: 36-42.
    • Lee SY et al.  A prospective, randomized, placebo-controlled, split-face clinical study on LED phototherapy for skin rejuvenation.  Jnl Photochemistry and photobiology B: Biology 2007; 88: 51-67.

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Boland Cell - Cell Technology - Aesthetic Biotechnology