(A UNIT OF M.V.HOSPITAL FOR DIABETES AT ROYAPURAM)

M.V.CENTRE FOR DIABETIC FOOT CARE, PODIATRY,

RESEARCH AND MANAGEMENT

(A unit of M.V.Hospital for Diabetes at ROYAPURAM )

1. INHOUSE FOOTWEAR MANUFACTURING UNIT

Proper footwear is one of the most important aspects of preventive foot care.

New types of footwear are now being prepared at M.V. Hospital for Diabetes,

Royapuram with technical assistance from Central Leather Research Institute

(CLRI) and Central Footwear Training Institute, Chennai for diabetic patients

with foot complications.

Patients in risk category 0,1(low risk) are provided comfortable footwear made of

good insole materials like mcp,pu soles etc.

Patients in risk category 2,3 (high risk) are given custom –made footwear .those

patients with previous ulceration, foot deformity are given custom made

footwear with moulded insole.

Our Unique Diabetic Footwear

Customized footwear for people with specific foot problems is being

manufactured at our M.V.Footwear unit at Royapuram.

2. NEUROMATRIX:

The NeuroMatrix biosensor is a noninvasive device in The Department of Podiatry and Foot care that helps in testing suralnerve conduction. As the feet of people with diabetes are at risk for complications especially due to lack of nerve sensitivity, this test is very useful for finding out the sensitivity of the Sural nerve in the foot. The normal testing time for a patient is 10 -15 seconds. Consultants will interpret the results and take the necessary steps to prevent foot complications.

RECENT ADVANCES MANAGEMENT OF DIABETIC FOOT ULCERS

1 .MAGNETOTHERAPY

Magnet therapy is being used for the treatment of painful diabetic peripheral neuropathy & diabetic foot ulcers. Proponents of magnet therapy believe that magnets increase blood flow, “nourishing” a painful area, and also may “repolarize” nerve impulses, changing the perception of pain & improves wound healing.

2. Growth factors

A. Recombinant human epidermal growth factor (REGEN-D 150), which was cloned and over expressed in E. coli, has shown enhanced healing of chronic diabetic foot ulcers (DFU) by significantly reducing the duration of healing in addition to providing excellent quality of wound healing and reepithelization

B. PLERMIN GEL

Topical growth factors have been used to good effect in wound bed preparation for chronic wounds. Recombinant human platelet-derived growth factor (rhPDGF) was the first such growth factor to be approved by the Food and Drug Administration (FDA) as a supplement for the treatment of chronic non-healing diabetic ulcers of the lower extremities. It has been found to significantly decrease the time to healing.

rhPDGF(recombinant platelet derived growth factor)

a. Helpsin wound proliferation

Epidermal growth factor

b. Helps in wound epithelialization 3. Platelet rich plasma (PRP)

Also known as Autologous Plasma Concentrate ( APC ) Delivers high concentration of Growth factors in the woundGrowth factors in PRP initiates chemotaxis, promotes proliferation & angiogenesisCan be used as a Gel preparation or local injection in and around the wound

4. Bone marrow aspirate(BMAC)

Improvement of ABI,Improvement in TcPO2,Reduction of painis observed in critical limb ischaemia.Bone marrow stem cells and progenitor cells are potential new therapeautic option to induce angiogenesis

5. Negative pressure wound therapy/ VAC

VAC therapy applies sub atmospheric pressure to the wound to

create an environment to promote wound healing by granulation

tissue formation

VAC has 3 components

1. VAC therapy unit: provides intermittent and continuous negative pressure

with safety features

2. Sensa T.R.A.C. Technology: regulates pressure 3. Granufoam / White foam

• Removes infectious materials • Provides protected wound healing environment • Removes exudate • Reduces edema provides moist healing environment • Promotes perfusion • Facilitates cell migration and proliferation

VAC – mechanism of action

a) macrostrain:

• Visible stretch that contracts the foam • Draws wound edges together • Provides direct and complete contact • Evenly distributes negative pressure • Removes exudates and infectious materials b) microstrain

• Microdeformation at the cellular level,which leads to cell stretch • Reduces edema

• Promotes perfusion • Promotes granulation by facilitating cell migration and proliferation

6. Hyperbaric oxygen therapy(HBOT)

Primary effects of HBOT: • Vasoconstriction • Angiogenesis • Leucocyte oxydative killing • Antibiotic properties • Toxin inhibition

Hyperbaric Oxygen Therapy (HBOT) is a method used to treat a variety of

ailments. Hyperbaric Oxygen Therapy is defined as a treatment in which a

patient breathes 100% oxygen intermittently under a pressure of greater

than sea level or our atmosphere. This treatment can be carried out in one

of two ways.

It is a method of administering pure oxygen at greater than atmospheric

pressure to a patient. By providing pure oxygen in a pressurized chamber

we are able to deliver 10-15 times more oxygen than if delivered at sea

level or at normal atmospheric levels. It has the capacity to promote the

growth of new blood vessels, decreases swelling and inflammation

deactivates toxins, increases the body's ability to fight infections, clears out

toxins and metabolic waste products, and improve the rate of healing.

Hyperbaric oxygen therapy involves breathing pure oxygen in a pressurized

room. Under these conditions, your lungs can gather up to three times

more oxygen than would be possible breathing pure oxygen at normal air

pressure.

Your blood carries this oxygen throughout your body, stimulating the

release of substances called growth factors and stem cells, which

promote healing

Mechanism:

Increasing the partial pressure of oxygen is the main therapeutic value of

hyperbaric oxygen therapy. When a patient breathes pure oxygen at 3

times atmospheric pressure, arterial oxygen pressures in excess of 2000

mmHb are possible. This is around 20 times higher than normal. This is

bactericidal to clostridium perringens, stops toxin production in gas

gangrene, and more rapidly displaces carbon monoxide from possible

neurological damage.

The diffusion of oxygen increases two to three times under hyperbaric

conditions in the hypoperfused wound. This restores tissue oxygen tensions

back to appropriate levels. Processes that are essential for wound healing

are oxygen dependent. Fibroblast proliferation, collagen production,

neovascularization and enhanced WBC function results in a rich vascular

bed for healing with or without skin grafting.

During-the-treatment:

During the treatment the patients receiving hyperbaric oxygen therapy will

be comfortably placed in the, breathing 100% oxygen under increased

atmospheric pressure. During the hour-long treatment, patients relax,

watch television or movies, or even take a nap while the highly trained

technicians carefully monitor them.

Hyperbaric Oxygen Therapy is a treatment option for diabetic patients with a foot ulcer, where the patient inhales 100% oxygen in a pressurized chamber. This method helps the body increase the oxygen levels in the blood. It also exposes the affected tissues to more oxygen than would otherwise be present, thus allowing for enhanced healing.

M.V.Hospital for Diabetes is the first single speciality hospital in Tamil

Nadu having Hyperbaric Oxygen Therapy Unit.

7. ELECTRONIC BAROPEDOMETER/ CUSTOMIZED INSOLES

Foot ulceration in persons with diabetes is the frequent causes for amputation

.Diabetic foot ulcers are commonly caused by peripheral neuropathy, peripheral vascular diseases, increased plantar pressure, intolerance of friction and abnormal shear forces caused due to alteration of mechanical stress and skin changes due to bony abnormalities, limited joint mobility

,Several studies have shown that the regular wear of therapeutic footwear, foot education, and diabetic foot care prevents ulceration, reduces re-ulceration and amputation. Apart from these, Customized insoles are prescribed to offload high pressures from the metatarsal heads and from other areas, which helps in reducing the risk of plantar ulceration.

The foot clinic at M.V hospital for diabetes has the facility of an advanced equipment, ELECTRONIC BAROPEDOMETER to prepare customized therapeutic moulded insoles. Electronic podometer is used to evaluate in an accurate way the following

parameters:

Pressure distribution in orthostatic condition.

Stabilometry of the patient in static position. Dynamic evolution of the pressure during the dynamic phase of step. Peaks of pressures and time of contact on the ground.

Individualization of areas at risk for the foot.

Comparison of the results of therapies adopted in time Helps in the design of plantar orthosis.

8. CORRECTIVE & SURGICAL PROCEDURES FOR LIMB

SALVAGE: A) EXTERNAL FIXATORS

External fixators cause less disruption of the soft tissues, osseus blood supply, and periosteum. This property makes fixators ideal for soft tissue management in the setting of acute trauma with skin contusions and open wounds, in chronic trauma where the extremity is covered in thin skin grafts and muscle flaps, and in patients with poor skin whose healing potential is compromised as in the case of peripheral vascular disease, diabetes mellitus, and Charcot disease.

B) OPEN FLEXOR TENOTOMY

This proceduremay be used in thetreatment of flexible digital contractures, and is especiallyuseful in distal digital hyperkeratotic lesions and/or distaldigital ulcerations or In the neuropathic or diabetic patient with preulcerativeor ulcerative distal lesions,. Used initially for mallet toe type deformities, the uses for this minimally invasive technique have been expanded to include flexor dominant hammertoedeformities, hallux malleus deformities, and floatingdigital deformities.

The key to choosing this procedure is that the digital deformity must be flexible or semi-rigid at the interphalangealjoint level and no contracture or a reducibledeformity at the metatarsophalangeal joint level. Open flexor tenotomy is most often utilized on thirdand fourth toes.The lesion pattern, hyperkeratotic, reulcerative, orfull ulcer, must be taken into consideration.

C) TA LENGTHEING :

Achilles tendon is one of the main biomechanical stresses that led to the ulceration. TA lengthening surgery is perfomed through a longitudinal incision at least 7cm in length. The subcutaneous tissue must be carefully dissected to

reduce risk of injury to the sural nerve. The deep fascia and paratenon must be carefully separated and then anatomically re-approximated. This procedure helps in healing of long standing forefoot ulcers in diabetic foot patients & also helps in preventing recurrence of ulcers at forefoot.

9. REVASCULARISATION SURGERY

Peripheral vascular disease is an important risk factor for lower extremity amputation in diabetic patients with chronic foot ulcers. There is a geographic difference in the prevalence of peripheral arterial disease in diabetes. Successful revascularization reduces the major amputation rate in diabetic patients. This can be achieved either by peripheral bypass or by percutaneous transluminal angioplasty. Recent studies are favouring peripheral angioplasty over traditional bypass surgery in diabetic lower limb. Datas from India reveals that only 3.32% of patients with diabeticfoot ischemia require vascular bypass procedures. revascularization procedures in diabetic foot patients helps in limb salvage .

10. Chennai amputation prevention services (CAPS)

“49-85% of all diabetic foot related problems are preventable” Bakker K. et al., 2005.

Chennai Amputation Prevention Service( external)

1. To provide – door step diabetes care, advice at a primary level in order

to prevent Amputation among Diabetic Patients. 2. To identify high risk foot and other diabetic foot complications and re-direct

to the centre for immediate attention and care. 3. To operate a helpline number to address the needs of diabetic patients with

complicated foot problems and provide care and advice at door step or

referred to the centre

4. To administer basic screening tests – fasting blood glucose, other screening

tests for nerves, vascular, eye and find out the risk level of diabetic

complications

5. To examine the foot for any diabetic complications and impart foot education

methods to prevent any recurrent ulceration or amputation and advice to

seek consultation in the centre.

6. To provide care at the primary level in the community including provision of

footwear and refer and seek specialist advice in the centre on need basis 7. To insist on the use of helpline number and utilize the services being

offered when there is a recurrence of foot problems.

CAPS:INTERNAL 8. Educating patients on diabetic foot care those who are attending our tertiary

centre. 9. Enrolling the high risk patients into this project

10. Giving intensive foot care education, offloading etc

11. Woundcare for the patients with footulcers

12. Preventing recurrrence of foot ulcerations &amputation –calling up for

regular followup 13. Home visit undertaken.

14. STIMULAN

STIMULAN is a truly absorbable calcium sulfate, specifically designed to

complement your dead space and infection management strategies.

• Approved for placement directly at the site of infection in bone and soft tissue

• May be mixed with antibiotics to protect the device from colonisation by

bacteria

• STIMULAN is a pharmaceutical-grade calcium sulfate that is the perfect partner for cases with an infected site – that may help improve surgical outcomes and lower overall costs of care.

GENETIC LAB:

1. Genetic association of IL-6, TNF-α and SDF-1 polymorphisms with serum

cytokine levels in diabetic foot ulcer

The IL-6 -174G/C (rs1800795), TNF-α -308G/A (rs1800629) and -238G/A (rs361525) and SDF-1 801G/A (rs1801157) are well characterized SNPs which have previously been linked to various diabetic complications.This SNPs in cytokine/chemokine genes serve as valuable biomarkers for DFU.

2. Is HSP70-hom (C2437T) Single Nucleotide Polymorphism (SNP) associated with Diabetic Foot Ulcer (DFU) among South Indian population?

HSP70-hom T/T genotype is highly associated with patients with DFU and their functional polymorphism may play an important role in the pathogenesis of DFU in type 2 diabetes in our South Indian population.

15. ANGIOGRAM

An angiogram is a special form of x-ray that permits

the diagnosis of blockages (occlusions) or narrowings

(stenosis) in the arteries of the body. During the test,

a tube (catheter) is inserted into an artery at the

groin. A special radio-opaque dye (contrast medium)

is injected down the tube and x-ray pictures are taken

as the solution passes along the blood vessels. The

whole procedure usually lasts approximately one

hour. The arteries take blood from the heart to supply

oxygen to muscles and organs and the angiogram will

tell your doctor if the supply of blood is abnormal. The

procedure is performed by a specialist interventional

radiologist or a vascular surgeon.

ANGIOPLASTY

BEFORE ANGIOPLATY AFTER ANGIOPLATY

Angioplasty with or without vascular stenting is a minimally invasive

procedure performed to improve blood flow in the body's arteries and veins.

In an angioplasty procedure, imaging techniques are used to guide a balloon-tipped catheter, a long, thin plastic tube, into an artery or vein and advance it to where the vessel is narrow or blocked. The balloon is then inflated to open the vessel, deflated and removed.

During angioplasty, a small wire mesh tube called a stent may be permanently placed in the newly opened artery or vein to help it remain open. There are two types of stents: bare stents (wire mesh) and covered stents (also commonly called stent grafts).

Angioplasty with or without vascular stenting is commonly used to treat conditions that involve a narrowing or blockage of arteries or veins throughout the body, including:

peripheral artery disease (PAD), a narrowing of the arteries in the legs or arms. In patients with PAD, angioplasty alone or angioplasty with stenting may be used to open up a blocked artery in the pelvis, leg or arm. 16. ANGIOSOMES

An angiosome is an anatomic unit of tissue (which has skin, subcutaneous tissue, fascia, muscle and bone), fed by a source artery. The treatment of ischaemia in

the diabetic foot should be aimed at therestoration of maximum blood flow to the foot with the restoration of palpable foot pulses whenever possible. This pulsatile flow increasesthe chance of wound healing and diminishes future skin breakdown and ulcer formation. In planning any surgical procedure on the foot, or when embarking on any course of wound care treatment, it is essential that optimum blood flow is obtained in the area of tissue breakdown. By understanding the principle of angiosomes and the vascular anatomy of the foot, wound healing and foot salvage will be easier to predict.

Foot laboratory:

a. Colour Doppler

ColourDoppler (duplex) scan to study the extent and severity of pvd and to aid the vascular surgeons to decide about mangemnet. b. Doppler studies: These non-invasive vascular tests can be used for: 1.dianosis and quantification of pvd (pheripheral vascular diseases 2.predicting wound healing ofr a diabetic foot ulcer 3.follow up and controlof treatment.

DRESSING MAETIALS:

DIFFERENT WOUND DRESSING MATERIALS:

The interactive dressings contain properties considered to actively influence the

wound healing processes. These dressings can be separated into different

categories:

• Alginate dressings: The dressings contain brown alga that will change to a gel in contact with wound secretions. The dressings are considered to have

autolytic and haemostatic properties. They can be used in wounds with

moderate or heavy exudation.

• Silver dressings: The silver impregnated dressings have antimicrobial properties and recommended to be used in infected wounds. Silver has antimicrobial properties but is reported to induce antimicrobial resistance.

• Hydrofiber dressings: The dressings compose of

natriumcarboxymethylcellulose with a high absorption capacity. They can be used in wounds with moderate or heavy exudation. Hydrofiber dressings

will change to a gel in contact with wound exudates. The dressings are considered to have autolytic properties.

• Hydrogels: The hydrogels contain abundant water and the

dressings moisturize the wound permitting autolytic debridement.

• Hydrocolloids: Hydrocolloid dressings moisturize the wound permitting autolytic debridement. These dressings are not recommended to be used in infected wounds.

FOAMS: Foam-based dressings are another popular choice for diabetic foot ulcers. The dressings have a wide range of absorbency, provide thermal insulation, and are easily cut toshape. Examples include Allevyn (Smith and Nephew) and Cavicare (Smith and Nephew). There have been few published data on their use in diabetic foot ulceration and none on their use in infection.

Product A:Aquacel Ag Product B:Hydroheal AM Ag

Product C:Intrasite gel and Co-mupimet granules

Product D:Atrauman Ag

Product E:BIATIAN ALGINATE

Product E:BIATIAN AG

Product F: HYDROCOLL

NERVE CONDUCTION VELOCITY :

In symptomatic diabetic neuropathy, there is slowing of nerve conduction

velocity owing to demyelination and loss of large myelinated fibers, and a

decrease in nerve action potentials owing to loss of axons. Nerve conduction

studies (NCS) are the most objective noninvasive measures of nerve function.

They represent a valuable tool of evaluation of neuropathy in large clinical and

epidemiological studies

Nerve Conduction Velocity and Electromyography Tests Nerve conduction velocity (NCV) and electromyography (EMG) tests are

sometimes used to help diagnose diabetic neuropathy.

NCV tests measure how long it takes nerves to transmit signals. Damaged nerves

don't transmit messages as quickly as they should.

EMG tests can help assess how well muscles are responding to the signals from nerves. If the nerves going to the muscles are damaged, they won't give clear signals and therefore, the muscles won't respond well.

All of these components—a physical exam, neurological exam, and other tests—

can help your doctor make an accurate diabetic neuropathy diagnosis.

CELLUTOME

CelluTome™ Epidermal Harvesting System

The CelluTome™

Epidermal Harvesting System is intended to reproducibly

harvest a thin skin graft for autologous skin grafting.

Device Description

The reusable components of the CelluTome™

Epidermal Harvesting System:

The Control Unit creates and regulates the vacuum and warming required to raise the epidermal microdomes. The Vacuum Head and tubing deliver the vacuum and warming from the Control Unit.

The disposable component of the CelluTome™

Epidermal Harvesting System:

The Harvester holds the suction microdomes that are raised for procurement. A

3M™

Tegaderm™

Film (catalog number: 1624W) is inserted into the Harvester

prior to cutting the microdomes. The 3M™

Tegaderm™

Film with the microdomes

is then applied to the recipient site.