Hey ABDM, thanks for your all the information sharing. Yes Prof Harding is a great asset for us to have, we have had a few dealing with TIS through Mercers S&N connections. Below I have listed a few things of interest, it’s a long read but some may find these snippets interesting. Resourced, I find my solace in my investment/s because I like to find my own things out and I consider peer reviews, trial data, research and collaberating information with others (within industry) really helps me to understand.
Anyway back to it
1. A short run down on VitroGro competitors, obviously there are more trying to enter but trial results talk. 2. What we can look forward to in the future for VitroGro 3. WHO findings on Ulcers 4. TIS trials and who we have dealt with (S&N connections)
(1) Competitors –
- Conventional dressings have been around for hundreds of years and don't produce effective results.
- Foams, hydrocolloids, hydrogels and alginates constitute the moist wound healing dressings that were invented in the 1960's these are better than dry dressings but are still ineffective in treating many chronic wounds even when combined with expert compression dressings for venous ulcers. In this group are also some animal collagen products which work reasonably but are not as cost effective as VitroGro will be, carry the risks of animal derived products and being from cattle and pigs are not acceptable to large parts of the worlds population.
- Cultured human cell products are too expensive, have been discontinued by S&N and are only available from a few small companies in the USA
- Negative pressure (NPWT) dressings and pumps work brilliantly for complex dirty wounds especially those where closure has to be delayed eg. military wounds but NPWT has not produced convincing results for chronic wounds and in many ways is impractical and too expensive for routing chronic wound care
- Growth factor pharmaceuticals have been both too expensive and don't produce effective results
- Hyperbaric oxygen is too expensive, too specialised, only available in a few centres but does help some patients
(2) Target Product Applications, a lot to look forward to with TIS:
* Diabetic, Venous & Pressure Ulcer Dressings - Accelerated healing, dressing changes x 1 or 2 per week - Correction of wound tissue pathology and delivery of physiologic, sophisticated ECM trigger for wound healing * Burns Dressings: Paediatric & Adult - Accelerated scarless healing * Surgical Wound Applications - Wound closure for at-risk patients e.g. obese, diabetic, smoker, advanced vascular disease - Other surgical applications e.g. stoma care * Product Cascade: Specialist Unit to Retail - Specialist unit - general hospital - outpatient - GP - pharmacy - retail - Potential retail applications include dressings, creams, lotions, product range for burns, chronic wounds, acute sunburn etc.
(3) Below is something I found very interesting regarding Ulcers bought out by the World Health Organisation in 2010, for me it is a must read by holders who want to know more, I've paste a few things of interest below but it is a 136pg document so put some time aside:)
Pressure ulcers have received significantly more publicity in recent years since the American Department of Health and Human Services introduced a National Pressure Ulcer Advisory Panel (13). This was followed by a European Pressure Ulcer Advisory Panel (14). These advisory bodies provide substantial advocacy for prevention. Patient, nurse and physician awareness has improved. Quite a few governments have legislated to improve bedding quality. In New South Wales, Australia, no long-term care home is permitted a mattress less than 15 cm thick. This followed a comprehensive Public Health Initiative (15) that produced usable guidelines. It is well documented that in countries where families in large numbers look after the bedridden, pressure ulceration is less prevalent. However, the increasing trend to one-child families and the reduced number of carers in the home pose a major threat to the enlarging elderly population (16).
Malnutrition is common in the rural developing world, resulting in delayed wound healing in those who have vitamin A deficiency and where pellagra is common, especially in alcoholics. This contributes to healing delay and, with associated niacin defi ciency, causes defects in the barrier function of the skin barrier (17).
3.2 WOUND TYPE, INCIDENCE AND PREVALENCE IN THE USA Countless wounds occur each year, but chronic wounds require the most skill, time, and resources to heal. The Wound Healing Society (WHS) defines a chronic wound as one that has failed to proceed through an orderly and timely repair process to produce anatomic and functional integrity (18). Such wounds involve damage to underlying tissue and structures as well as the integrity of the skin itself. The most common types of chronic wound are leg ulcers, pressure ulcers, and diabetic foot ulcers. Underlying medical conditions often cause chronic wounds. Older adults are more likely to develop chronic wounds. With ageing, the protective layers of the skin diminish, placing the patient at greater risk of injury. As the USA population ages, the incidence of chronic wounds is expected to rise significantly to an estimated 57 million (19).
3.2.1 VENOUS LEG ULCERS Venous leg ulcers are the most common type of chronic wound, with an incidence of 2.5 million each year (20). There have been several reviews of the epidemiology of venous insuffi ciency in the developing world (2123). In black skin, early venous insufficiency presenting as varicosities is more diffi cult to see. This is important because such insufficiencies are common in the lymphoedema population, and it can be a principal cause of leg swelling as well as of ulceration (see CHAPTER 6).
3.2.2 PRESSURE ULCERS Over 2 million pressure ulcers occur each year in the USA. One third of patients admitted to a critical care unit develop a pressure ulcer. Approximately 15% of hospitalized patients aged 65 or older develop a pressure ulcer during a 5-day stay or longer (2426). In Zimbabwe, the treatment of burns and pressure ulcers with plastic surgery is more likely to experience graft failure, and pressure ulcers are more common in people with AIDS (27).
3.2.3 DIABETES MELLITUS According to the American Diabetic Association, 20.8 million children and adults or 7% of the USA population have diabetes. Of signifi cant concern is the higher incidence of diabetes in specifi c ethnic or age groups : age 20 years or older, 9.6% ; age 60 or older, 20.9% ; non-Hispanic whites, 8.7% ; Hispanic Americans, 9.5% ; Native American Indians, 12.8% ; and Afro-Americans, 13.3%. Diabetic individuals are especially prone to foot ulcerations and chronic wounds that are difficult to heal. Diabetic foot ulcers affect approximately 15% of the diabetic population (28) and account for more than 82 000 amputations annually (29). The statistics listed above do not include the incidence of complex wounds such as non-healing surgical wounds and burns.
Diabetes-related lower extremity chronic wounds are the most likely subject for epidemiological reporting in resource-poor countries. While the statistics are difficult to detail, certain generalizations can be inferred. For example, it is estimated that approximately 15% of the more than 150 million people with diabetes worldwide will at some stage develop diabetic foot ulceration. This situation is worsening as diabetes becomes an emerging epidemic. Foot problems are ubiquitous ; all parts of the world report the development of foot lesions as a consequence mainly of neuropathy and peripheral vascular disease. The prevalence of active foot ulceration varies from approximately 1% in certain European and North American studies to more than 11% in reports from some African countries (30). Compounding the problem is the fact that diabetes may not be treated because of insulin expense. In such cases, neuropathy and foot ulcers accelerate, and with poor foot care, the rate of amputation increases.
3.3.1 INDIA Wounds, and particularly chronic wounds, are a major concern for the Indian patient and clinician. Chronic wounds affect a large number of patients and seriously reduce their quality of life. While there are few Indian studies on the epidemiology of chronic wounds, one study estimated the prevalence at 4.5 per 1 000 population. The incidence of acute wounds was more than double at 10.5 per 1 000 population (31). The etiology of these wounds included systemic conditions such as diabetes, atherosclerosis, tuberculosis and leprosy. Other major causes included venous ulcers, pressure ulcers, vasculitis and trauma. The study report stated that inappropriate treatment of acute traumatic wounds was the most common cause of the chronic wound. In India, as in other under-resourced nations, the problem of chronic wounds is compounded by other demographic factors, such as low literacy rates, poor access to health care, inadequate clinical manpower, and a poor healthcare infrastructure. Inadequate education and clinical training in the fundamentals of basic wound care greatly magnify the problem in India. India has had its first wound healing programmes only in the last decade. Major textbooks on wound healing have only recently appeared on the shelves (32).
In India, as in many developed countries, diabetic foot disease now results in major debilitating complications with severe morbidity and increased amputations. A high prevalence of neuropathy promotes recurrence of foot lesions, more than 50% after three years. Unfortunately, these chronic wounds are often inadequately treated (33).
India remains the nation with the highest and virtually unchanged new case detection rate of leprosy. Severe disabilities and ulceration are common, and the custom of begging and the prevailing caste system do little to improve rates of healing.
3.3.2 CHINA AND VIET NAM The prevention and management of chronic skin ulcers in lower extremities continues to be a severe problem in China (34). Wound healing in these injured tissues is a major health-care problem with considerable socioeconomic impact. According to data from epidemiological studies, the incidence of chronic ulcers in surgical hospitalized patients in China is 1.5% to 20.3%. The site distribution of these wounds varies with etiology. In one study, of the 580 wound areas in 489 patients, 366 or 63% were ulcers on the lower extremities. The principle etiology (67%) of ulceration is trauma or traumatic wounds compounded by infection. This highlights the need for traumatic wound prevention programmes. Diabetic ulcers, venous ulcers and pressure ulcers accounted for 4.9%, 6.5%, and 9.2%, respectively. The majority of these wounds were seen in farmers and other agricultural workers (35).
China with its 1.3 billion population will add to the global statistics on emerging epidemics. The age- standardized prevalence of metabolic syndrome and overweight was 9.8% in men and 17.8% in women in a 2005 study (36). China is the country with the greatest number of burns. Chinas many, mostly military, burns units achieve a very high standard of care and there is distinguished research into skin equivalents and stem cells. Access to data is through two leading journals, The Chinese Journal of Burns, Wounds and Surface Ulcers and Burns (37). This high level of care is mostly available for the wealthy city population. There are 900 million people living outside the cities who have much less access to care due to distance and poverty. The treatment of burn victims in Viet Nam has steadily improved since the National Society for Burn Injuries was formed two decades ago (38). For twenty years, they had little access to therapies from outside Viet Nam and their research into herbals and the application of frog skin reached an advanced state. They were pioneers in the training of caregivers in the General Health Services. As a result, in many cases, the poor appear to have more affordable care than in neighbouring China. China has a residual population of patients affected by leprosy. In Yunnan province, there are 120 leprosy villages and the prevalence of untreated ulcers is very high (39).
3.3.3 MEXICO Diabetes is the third leading cause of general mortality in Mexico. Between 8% and 12% of the general population in Mexico, 46 million people, currently have diabetes. The number rises to 21% in people above 65 years of age. It is estimated that by the year 2025, Mexico will have the highest incidence of diabetes in Latin America and the seventh highest incidence of diabetes worldwide. Only 200 000 300 000 of the people with diabetes are believed to have the disease under control. Approximately 30% of Mexicans with diabetes do not know they have the disease. Diabetes is the chief cause of lower extremity amputations in Mexico. More than 75 000 legs were amputated in the year 2000. No statistics are currently available on venous or pressure ulcers in Mexico (40).
3.3.4 CAMEROON In a recent study of 300 diabetic patients, the incidence of diabetic foot ulceration ranged from 25.6% (inpatient) to 11.1%. The authors stated, Diabetes mellitus, a non-transmissible disease, is a worldwide epidemic, especially in Africa and Asia, the diabetic foot being one of the most severe and frequent complications. Its cost is among the highest of the diabetic chronic complications. The struggle against that burden relies upon the prevention (education of patients and caregivers, early detection of the lesions) and upon a multidisciplinary approach and treatment. In sub-Saharan Africa and especially Cameroon, emphasis must be put on education of both patients and caregivers (41).
3.3.5 UNITED REPUBLIC OF TANZANIA In a literature review by Abbas & Archibald (42) covering 19602003, diabetic foot complications such as ulceration, infection or gangrene were associated with longterm disability and premature mortality. Rates of complications varied by African country : for foot ulcers, 419% ; peripheral neuropathy, 484% ; peripheral vascular disease, 2.978% ; frequency of patients presenting with gangrenous foot ulcers, 0.669% ; foot amputation rates, 0.345%. A study of diabetic patients in the United Republic of Tanzania showed mortality rates above 50% among patients with severe foot ulcers who did not undergo surgery (42).
3.3.6 MALAWI In a prospective study conducted at Queen Elizabeth Central Hospital, Blantyre, by two surgeons Virich & Lavy, data from 200 consecutive patients with wounds were collected over a two-week period using a standard pro forma (43). Assaults were the principal cause of wounding (26.5%). Industrial injury and accidental self-injury also were common (17.5% and 12.5%, respectively). Lacerations were by far the most common type of wound encountered (67.5%). The most common anatomical site of injury was the hand (23.5%), while the trunk accounted for only 6% of injuries. Males were approximately four times more likely to present with a wound than females. The age of patients affected ranged from 2 to 76 years, with the commonest group affected from 16 to 25 years : 35% of all wounds occurred in this group. In a study of people with leg ulcers attending the Central Hospital in Blantyre, Dutch authors found that venous and diabetic ulcers were rare but that infective causes and malignancy, perhaps resulting from HIV/AIDS, were common. They emphasized the value of biopsy and need for it, and therefore of histopathological services (44). The above-mentioned countries addressed in this chapter are only a sample of available statistics. All of these countries have threats of increasing poverty and widening separation of economic opportunities as the middle class enlarges. The middle classes expect and receive better services. It is expected that every nation will have some capacity to adapt fundamental gold standards as the private sector contributes to the raising of standards of care. It is anticipated that these gold standards may trickle down to the impoverished majority who at present cannot afford them.
3.4 TROPICAL ULCERS In western countries, most chronic wounds are due to venous insuffi ciency, arterial disease, diabetes, pressure or some combination of these factors. In tropical countries where few large series of leg ulcers have been reported, the prevalence and etiology of leg ulcers are largely unknown. A study based in one centre suggested that the chief causes of lower extremity wounds in the hospital were : leprosy (40%), diabetes (23%), venous disease (11%), and trauma (13%) ; 13% of the wounds were given no diagnostic etiology (45). Buruli ulcer (BU) (46) has been reported from 30 countries in Africa, the Americas, Asia and the Western Pacifi c, mainly in tropical and subtropical regions. Approximately 24 000 cases were recorded between 1978 and 2006 in Cte dIvoire. Nearly 7000 cases were recorded between 1989 and 2006 in Benin. More than 11 000 cases have been recorded since 1993 in Ghana. Increasing numbers of cases of BU have been reported recently : 25 in 2004, 47 in 2005 and 72 in 2006 in Australia (47). Infection by Mycobacterium ulcerans begins as a dermal nodule. Lymphoedema may extend well beyond the nodule. Ulceration follows and is often extensive. Surgical management and physiotherapy to prevent scarring are demanding on hospital practice. Early BU is curable by appropriate antibiotic therapy and early nodule excision. When adipose tissue is perceived as part of the skin disorders, BU can be treated as skin failure (48).
There have been a few studies describing the epidemiology of the tropical ulcer (49-50). It seems apparent that a paucity of education and training in countries with poor health resources has resulted in a consensus view regarding the diagnosis as a mixed aerobic and anaerobic infection.
In reviewing the etiology, epidemiology, clinical findings and treatment of the common ulcers in the tropics, it is apparent that these lesions have much in common with complex wounds seen in western countries. Most of the ulcers have the characteristics of an infectious etiology : minor trauma, positive bacterial cultures, purulent exudates, pain, peri-wound oedema and tissue necrosis. Tropical phagedenic ulcer and Bazins nodular vasculitis all have common fi ndings. Each of these clinical findings can be addressed by the basic fundamentals of modern wound treatment : enhancing systemic factors, protecting the wound from trauma, debridement, control of infection, moist wound care, and control of oedema/lymphoedema (51).
The Guidelines resulting from this document may include the concept of Treatment of Skin Failure, which is sustainable, available at low cost at the local level, and appropriate for the majority of common conditions so classifi ed. Chronic wounds are a global epidemic. With wound care education intervention, it seems apparent that a new era is about to revolutionize global wound care. This will be a vitally important WHO initiative.
(4) Who is in our corner and head up recently and in the past for our trials, interestingly they are on Smith & Nephews advisory board also!!
Keith Harding (text from the Smith and Nephew site) Professor of Rehabilitation Medicine (Wound Healing) University of Wales College of Medicine, UK Keith Harding, MB ChB, MRCGP, FRCS is a professor of Rehabilitation Medicine at the University of Wales College of Medicine with an expertise in basic science and prevention and treatment of all chronic wounds. For the past ten years he has been director of the Wound Healing Research Unit, a self funded unit within the College of Medicine, designed to provide academic and clinical focus in wound healing. Professor Harding is a founding member of the European Wound Management Association, President of the European Tissue Repair Society. He has authored over 200 publications in peer review journals. From 1980-1990 he was principal in General Practice in Cardiff, UK.
*** For our Aussie trials ***
(Sept announcement by TIS) This human trial of VitroGro? was conducted by Professor Michael Stacey at the Vascular Research Laboratory in Western Australia and statistical analysis was performed by staff from the University of Western Australia.
Michael Stacey (text from the Smith and Nephew site) Associate Professor of Surgery, Fremantle Hospital, Australia Michael Stacey is a general and vascular surgeon and has a research interest in wound healing and chronic venous disease. His specific research interests are in the biochemistry and molecular biology of impaired healing in chronic venous ulcers. He also has research interests in venous physiology, pressure ulcers and diabetic foot ulcers. He was Inaugural President of the Australian Wound Management Association. He is currently Chairman of the World Union of Wound Healing Societies, and is on the Editorial Board of a number of journals associated with wound healing, in particular Wound Repair and Regeneration, The Journal of Wound Care, and Primary Intention.
*** For our Canadian trials ***
(From Nov 09 CEO Presentation) Two sites: - Professor Michael Stacey, Australia, targeting venous ulcers - Professor Gary Sibbald, Canada, targeting diabetic and venous ulcers
R. Gary Sibbald (text from the Smith and Nephew site) Professor of Medicine and Public Health Science, Director of Continuing Education, Department of Medicine, University of Toronto Director, Dermatology Day Care and Wound Healing Clinic, Sunnybrook and Women's College Health Sciences, Toronto, Canada Professor R. Gary Sibbald is a specialist in internal medicine and dermatology with a special interest in chronic wound care and a master?s degree in education. He was a founding board member of the Association for Advancement of Wound Care in the United States and a co-founder and past chairman of the Canadian Association of Wound Care. His dermatology expertise led to his roles as advisory council executive member for Canada of the American Academy of Dermatology and a previous president of the Toronto Dermatological Association. Professor Sibbald is the director of continuing education for the Department of Medicine at the University of Toronto and chair of the Faculty Continuing Education Committee and a board member of the Canadian Association of Continuing Health Education.
Presently, Professor Sibbald is the director of the Dermatology Daycare and Wound Healing Clinic at the Women?s College Campus of Sunnybrook and Women?s College Health Sciences Centre. He is the director of the International Interdisciplinary Wound Care Course at the University of Toronto and co-editor of the Third Edition of Chronic Wound Care: A Clinical Source Book for Healthcare Professionals.
On the international scene, he is the chair of the Education Committee of the World Union of Wound Healing Societies. Dr. Sibbald has lectured and presented at over 500 scientific meetings on five continents. He has published over 100 articles and book chapters.
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