Stryker’s T2 ICF Nail System Offers Surgeons New Option for Patients Suffering from Serious Foot Conditions

Media Release:

MAHWAH, N.J., September 28, 2020—Stryker’s Trauma & Extremities division today announced the launch of its T2® ICF Intramedullary nailing system, offering a solution for patients suffering from serious foot conditions such as Charcot foot—a condition associated with diabetes resulting in poor bone quality, possible nerve damage and potential foot ulcers.1

The T2 ICF system is a stable product that provides a surgical option designed to prevent nail back out and promote fixation and accuracy. It is estimated that a leg is amputated every 30 seconds globally, and 85% of these amputations are the result of diabetic foot ulcers.2

“We are always looking for ways to improve fixation strategies in Charcot patients, as they tend to have poor bone quality and often end up needing limb-salvage procedures,” said Vinod Panchbhavi*, MD, FACS, FAOA, FABOS, FAAOS, Professor and Chief of Ankle & Foot Surgery, UTMB Health. “The T2 ICF nails are lightweight and sturdy, are easy to use.”

“This medial and lateral column nail provides rigid fixation with the ability to apply up to 10 millimeters of compression through the nail3,” said William Simon*, DPM, Bayview Physicians Group, and designer of the T2 ICF nail. “The stable nail is designed to be compatible with cross screws to help prevent nail back-out4 and the large nail diameters are intended to help prevent nail breakage3.”

The T2 ICF Intramedullary nailing system can also be used to treat other conditions such as fracture fixation, osteotomies, non- and mal-unions, and fusions.

Early treatment for leg ulcers leads to better outcomes for patients

Media Release:

Venous leg ulcers are common and distressing, affecting around 1 in 300 adults in the UK. They are open, often painful, sores on the leg that take months to heal and can develop after a minor injury. People with enlarged veins known as varicose veins are at high risk of developing venous leg ulcers, as they have persistently high pressure in the veins leading to skin damage.

In a clinical trial, led by researchers at Imperial College London and clinicians at Imperial College Healthcare NHS Trust, 450 patients with venous leg ulcers were treated with early surgical interventions. This resulted in faster healing and a reduced risk of the condition coming back compared with current methods of treating patients with compression stockings and delayed surgical interventions.

The researchers behind the study, published in JAMA Surgery, suggest that current guidelines on treating leg ulcers should be revised to include early assessment of varicose veins and surgical treatment of leg ulcers to deliver clinical benefits and cost savings for the NHS. They suggest that this early treatment intervention could save the NHS an estimated £100 million per year.

Lead author of the study Professor Alun Davies, Professor of Vascular Surgery at Imperial College London and a Consultant Surgeon at Imperial College Healthcare NHS Trust, said:

“Venous leg ulcers cause enormous physical and mental distress to patients as well as having a financial impact on the NHS. Our study is the first to show that early surgical treatment of leg ulcers leads to faster healing and the reduced risk of the ulcer coming back compared to current methods.

The NHS spends around 2 per cent of its budget on managing lower limb wounds and there is an urgent need to find more effective treatments. We believe that the current guidelines should be changed so that patients with leg ulcers are treated with surgery at an earlier stage. This approach will lead to better outcomes and improve patients’ quality of life.”

The main treatment for leg ulcers is compression bandages or stockings, to improve the vein function in the legs. There are also surgical treatments such as endovenous ablation – a ‘keyhole’ treatment to close varicose veins. The treatment, under local or general anaesthetic, involves a small fibre passed through a catheter and positioned at the top of the varicose vein. The fibre delivers bursts of energy that heat up the vein and seal it closed. However, under current guidelines this treatment is not usually offered until the ulcer has been present for many months, if at all. Furthermore, if the underlying cause of the ulcer is not treated there’s a high risk of the ulcer coming back after treatment.

The researchers wanted to see whether performing endovenous ablation to treat varicose veins at an earlier stage can lead to faster healing and reduce the risk of venous leg ulcers returning, requiring further treatment.

Researchers recruited 450 patients with venous leg ulcers from October 2013 to September 2016. All patients had leg ulcers of less than six months old and were treated at 20 hospitals in the UK, including Imperial College Healthcare NHS Trust hospitals. Two hundred and twenty four patients were randomly assigned to receive endovenous ablation within two weeks of randomisation followed by wearing compression stockings. The rest of the patients were given compression stockings but the endovenous ablation treatment was delayed by six months or until the ulcer was healed. The researchers then followed up over a period of five years to compare how quickly they healed and the rate of leg ulcer recurrence after treatment.

Of the 426 participants whose leg ulcer had healed, 121 participants experienced at least one recurrence during follow-up. In the early-intervention group, 56 patients experienced recurrence during follow-up. In comparison, 65 participants in the delayed intervention group experience recurrence during follow-up. The rate of recurrent ulcers was 60 per cent higher in the deferred intervention group (0.16 per year of follow-up compared to 0.1 per year in the early-intervention group). They also found that healing was shorter in the early intervention compared to the deferred intervention group.

The team compared the cost of early surgical intervention with delayed intervention over three years and found that early intervention was, on average, the less costly strategy over three years.

Study shows the major impact of diabetes on the risk of falls

Media Release:

New research presented at this year’s annual meeting of the European Association for the Study of Diabetes (EASD), held online this year (21-25 September), shows that having type 1 diabetes (T1D) is associated with a 33% increase in the risk of falls compared with the general population, while having type 2 diabetes (T2D) is associated with a 19% increased risk of falls. The study is by Nicklas Rasmussen, Steno Diabetes Center and North Jutland Aalborg University Hospital, Aalborg, Denmark, and colleagues.

People with diabetes can be at increased risk of falls as they tend to have more complications (for example high and low blood sugar), and use of medication compared with the general population without diabetes. This study aimed to estimate the risk of falls and to identify risk factors associated with increased falls in people with diabetes compared with the general population. The second aim was to estimate fall-related injuries including fractures and where in the body these fractures are occurring compared with the general population.

From the Nationwide Danish National Patient Register the authors identified 12,975 people with T1D and 407,099 people with T2D and a sex- and age-matched control group (1:1) from the general population. All episodes of people hospitalised with a first fall from 1996 to 2017 were analysed using computer modelling. Risk factors such as age, sex, diabetic complications, a history of alcohol abuse and a history of medication were included in an adjusted analysis. The incidence rates, incidence rate differences and incidence rate ratios of falls and the location in the body of fall-related injuries and fractures were calculated.

In the adjusted analysis T1D was associated with 33% increased risk of a first fall, and T2D a 19% increased risk. The cumulative incidence, of falls requiring hospital treatment was 13% in T1D, and 12% in T2D.

For patients with T2D, other risk factors for falls were: being female (60% increased risk), being aged over 65 years (32%), use of selective serotonin receptor inhibitors (SSRIs) (used to treat depression) (32%), use of opioids (9%), SSRIs and opioids combined (60%), and a history of alcohol abuse (a near doubling of risk).

For patients with T1D, other risk factors identified for falls were: being female (20 % increased risk) aged over 65 years (30%), use of SSRIs (35%), use of opioids (15%) and a history of alcohol abuse (77%).

Increased incidence of fractures was also identified in people with T2D. Compared with the general population, there was increased risk of fractures of the hip and femur (2%), humerus (the long arm bone) (24%), radius (forearm bone) (39%) and skull/face (15%). People with T1D also had an increased risk of fractures, but only at the hip and femoral region (11%).

The authors say: “While of course we cannot do anything about getting older or our gender, diabetes – especially type 2 diabetes – use of medications and alcohol abuse could be potentially modifiable risk factors for falls. Gaining further information on risk factors for falls could guide the management of diabetes treatment such as the choice of medication, which enables us to improve treatment particularly in people with a high risk of falls and fractures associated with high mortality.”

MiMedx Concludes Enrollment For Phase 3 Plantar Fasciitis Trial

Media release:

MARIETTA, Ga., Sept. 17, 2020 (GLOBE NEWSWIRE) — MiMedx Group, Inc. (OTC PINK: MDXG) (“MiMedx” or “the Company”), an industry leader in advanced wound care and an emerging therapeutic biologics company, today announced the conclusion of enrollment for a Phase 3 study of plantar fasciitis, an inflammation of the fibrous tissue along the bottom of the foot that results in intense pain. This key clinical trial explores how placental science may address and treat musculoskeletal pain and function disorders. The study has met its timelines.

“Plantar fasciitis is an all-too-common, debilitating and painful foot condition that challenges both patients and clinicians. Several months to years of treatment may be required with conservative therapies before symptoms subside, and I believe plantar fasciitis represents a significant unmet patient need,” said Stuart Miller, M.D., Principal Investigator, Department of Orthopaedic Surgery, MedStar Union Memorial Hospital, and Assistant Professor, Department of Orthopaedic Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland. “This is a landmark study that will help us advance the science and elevate the standard of care for millions of patients; I look forward to analyzing and publishing the data regarding treatment efficacy for this musculoskeletal condition. Our progress to date is all the more gratifying given the dampening effect of the pandemic on patient enrollment. This study is designed to provide statistically significant evidence of efficacy for this biologic treatment to reduce pain and improve function.”

More than two million people are treated for plantar fasciitis inflammation in the United States annually. In 10% of patients treated with traditional measures, the condition progresses to chronic plantar fasciitis-related pain – recovery from which is lengthy and recurrence of which is very common, with an estimated $284 million annual national economic burden. The current treatment algorithm aims to maintain arch shape, modify foot loading and/or improve shock absorbency of the heel through night splints and orthotics. While they may assist in reducing pain associated with plantar fasciitis, these treatments do not address the root cause of the condition, which is thought to be both degenerative and inflammatory.

Timothy R. Wright, MiMedx Chief Executive Officer, commented, “Given the variability of efficacy, cost, and potential side effects of available plantar fasciitis treatment options, additional evidence-based alternatives are needed urgently. As a pioneer in the development of placental tissue technology, following through on clinical research is part of our mission to improve patient outcomes. Using our placental science platform to address the unmet need posed by plantar fasciitis is just one of the critical ways that we are exploring its application to improve people’s lives. We look forward to sharing the results of this trial in 2021.”

About the MiMedx Plantar Fasciitis Trial
This study is a Phase 3, prospective, double-blinded, randomized controlled trial of the micronized dehydrated Human Amnion Chorion Membrane (dHACM) injection as compared to saline placebo injection in the treatment of plantar fasciitis. The trial enrolled 276 patients between the ages of 21 and 79 years, with an investigator-confirmed diagnosis of plantar fasciitis for ≥ 1 month (30 days) and ≤ 18 months. Patients were required to have a Visual Analog Scale (VAS) Pain scale of ≥ 45 mm at randomization and be receiving conservative treatment for ≥ 1 month (30 days), including any of the following modalities: Rest, Ice, Compression, Elevation (RICE); stretching exercises; NSAIDs or orthotics. The primary endpoints are change in VAS for Pain at 90 Days and incidence of related adverse events at 180 days, serious adverse events and unanticipated events during the first 12 months post-injection. Secondary endpoints include self-reported responses to the Foot Function Index – Revised (FFI-R) at 90 days.

Biomechanics: Wearing footwear with toe springs requires less muscle work

Press Release:

Wearing footwear with an upward curvature at the front of the shoe – known as the toe spring – requires less work from the muscles of the feet to walk than shoes with a flatter sole, according to an experimental study published in Scientific Reports.

Toe springs keep the toes continually elevated above the ground in a flexed upwards position to help the front part of the foot roll forward when walking or running and are present in most modern athletic shoes, but their effect on natural foot function and vulnerability of the feet to injury has not been widely studied.

Freddy Sichting and colleagues from Harvard University, the Chemnitz University of Technology and Buffalo University investigated the effects of toe springs on foot biomechanics using a controlled experiment in which 13 participants walked barefoot on a treadmill at a comfortable walking pace. The participants were then asked to repeat the process wearing four different pairs of specially designed sandals with varying upward curvature of the toe region in order to simulate the curvature of modern athletic footwear. 3D motion data were captured using markers placed on each subject’s knee, ankle and foot.

The authors found that toe springs decrease the work of the muscles around the joints that connect the toes to the foot bones. The higher the upwards curve of the toes in respect to the rest of the foot, the less work the foot muscles had to perform to support the joints when walking.

The findings explain why toe springs are so comfortable and popular but suggest that shoes with toe springs may contribute to weakening of the foot muscles with long-term use. This may increase susceptibility to common pathological conditions such as plantar fasciitis, inflammation of the foot that connects the heel bone to the toes, according to the authors.

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‘Do corns have roots?”

The question ‘do corns have roots?” gets searched for in Google about 300 times a month. It could be assumed to be done by those who want to know why there ‘corns’ keep coming back and if the reason for that is that they have roots, like plant roots that they grow back from.

Corns on the feet do not have roots. If a corn is removed and it comes back, then that is simply because what caused it in the first place is still there. Unless the cause is removed, then it will come back.

The myth needs to go away and Podiatrists need to do a better job at educating the community about the myth.

A new approach to understanding the biology of wound healing

Press Release:

PHILADELPHIA – Our bodies frequently heal wounds, like a cut or a scrape, on their own. However patients with diabetes, vascular disease, and skin disorders, sometimes have difficulty healing. This can lead to chronic wounds, which can severely impact quality of life. The management of chronic wounds is a major cost to healthcare systems, with the U.S alone spending an estimated 10-20 billion dollars per year. Still, we know very little about why some wounds become chronic, making it hard to develop effective therapeutics to promote healing. New research from Jefferson describes a novel way to sample the cells found at wounds – using discarded wound dressings. This non-invasive approach opens a window into the cellular composition of wounds, and an opportunity to identify characteristics of wounds likely to heal versus those that become chronic, as well as inform the development of targeted therapies.

The study was published in Scientific Reports on September 15th.

“Studying wound healing in humans is very challenging, and we know very little about the process in humans,” says Andrew South, PhD, Associate Professor in the Department of Dermatology and Cutaneous Biology and one of the lead authors of the study. “What we do know is from animal studies, and animal skin and the way it heals is very different from human skin.”

Dr. South and his lab study a group of inherited skin diseases called epidermolysis bullosa (EB), where wound healing is severely impaired. Patients, often from birth, suffer from blisters and lesions that are slow to heal, and some become chronic. In a subset of patients, chronic wounds are at high risk of developing into aggressive skin cancer. At this time, it is very difficult to predict which wounds in a given patient will heal, and which won’t. Being able to sample the wounds is a key to understanding the mechanisms behind healing.

“Performing a biopsy to sample the cells in the wound would help us understand the differences between these wounds,” says Dr. South “But biopsy in these patients is extremely painful and could delay healing of the wound even further. On the other hand, collecting these bandages that are just going to be thrown away, it poses no harm to the patient, and can be applied to a variety of conditions where wounds don’t heal properly.”

The researchers, which included collaborators in Chile and Austria, collected and analyzed 133 discarded wound dressings from 51 EB patients. Both acute and chronic wounds were sampled, with acute defined as present for 21 days or less, and chronic as present for more than 3 months.

“Previous studies had used wound dressings or bandages to collect fluid and look at what proteins are in there,” says Dr. South. “But no one has actually looked at what cells are present. Applying the techniques our lab frequently uses, we were able to isolate viable or living cells from the dressings.”

The researchers recovered a large number of cells from the dressings, often in excess of a 100 million. The larger the wound, and the more time a dressing was on a wound, the more number of cells were recovered.

The researchers then characterized the cells to see what type of cells are present at the wound. They detected a variety of immune cells including lymphocytes, granulocytes or neutrophils, and monocytes or macrophages. When comparing dressings from acute and chronic wounds, they found a significantly higher number of neutrophils at chronic wound sites. Neutrophils are the first line of defense in our immune system, and when a wound starts to form, they’re the first ones to arrive at the scene.

“Previous findings from animal studies and protein analysis of human wound dressings had supported the idea that when neutrophils hang around longer than they should, that stalls the healing process and can lead to chronicity,” says Dr. South. “Our findings support that theory more definitively, by showing that chronic wounds are characterized by higher levels of neutrophils.”

These findings give more insight into wound healing, and could help develop therapies that promote the process; for instance, those that neutralize excess neutrophils, or recruit macrophages, the immune cells that begin the next stage in healing after neutrophils.

The researchers now plan to expand on their technique, by further analyzing the individual cells collected from the wound dressings, and the genetic material inside them. “Currently we’re working with colleagues in Santiago, Chile on collecting dressings from EB patients over a period of time,” says Dr. South. “This allows us to follow patients longitudinally, and observe a wound and how its cellular composition changes as it heals or doesn’t heal.”

The team hopes that this will reveal genetic markers that can predict healing or chronicity.

“This method of sampling could be an alternative to bothersome swabs or blood draws, which are especially hard to do in newborns,” says Dr. South. “Since we know EB can present at birth, this technique could give us really early insight into the how severe the disease might be.”

While the current study focuses on EB, Dr. South and his colleagues hope that this technique can be applied to a variety of other conditions, such as diabetic foot ulcers and vascular leg ulcers.

“The field of wound healing has been crying out for a better understanding of what drives a chronic wound,” says Dr. South. “This technique could be transformative, and eventually help patients live more comfortable and healthy lives.”