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.

Heel Pain on the Rise among Americans in Quarantine

Press Release:

BETHESDA, Md., May 27, 2020 /PRNewswire/ — Members of the American Podiatric Medical Association (APMA) have noted an increase in reports of heel pain from patients stuck and home as a result of the COVID-19 pandemic. APMA member podiatrists are physicians and surgeons who treat the foot, ankle, and related structures of the leg, and they say footwear—or lack thereof—may be to blame for the upsurge in cases.

“Adults are shifting routines and adapting to new working environments, and it’s easy to neglect proper care and support for your feet,” said APMA member podiatrist and spokesperson Priya Parthasarathy, DPM. “Many podiatrists now have telehealth and in-person appointments. Foot and heel pain is never normal, so see your podiatrist right away!”

Plantar fasciitis, one of the most common causes of heel pain, is inflammation of the band of fibrous connective tissue (fascia) running along the bottom (plantar surface) of the foot, from the heel to the ball of the foot. This condition may cause intense pain in the heel, along with redness, swelling, or heat. This pain may be most acute when a patient takes the first step in the morning or after sitting. Many Americans in quarantine are wearing unsupportive shoes—or wearing no shoes at all—which can contribute to inflammation.

“The top priority when treating plantar fasciitis is to reduce the mechanical strain on the plantar fascia with arch supports and supportive footwear,” said APMA President Seth A. Rubenstein, DPM. “Most cases of plantar fasciitis respond well to conservative (non-surgical) treatment, including anti-inflammatory measures and stretching. However, podiatrists are also well-trained to provide advanced, cutting-edge treatments, including EPAT therapy, platelet-rich plasma injections, and surgical intervention, for more complex cases.”

Although some patients assume all heel pain is attributable to plantar fasciitis, many conditions can cause similar symptoms. Seeing a local APMA-member podiatrist at the first sign of heel pain allows for proper diagnosis and treatment. Other causes of heel pain include heel spurs, Achilles tendinitis, stress fractures, and excessive pronation.

Can the bunion correctors actually help correct bunions?

A simple search of Google will not give you the answer to the question as if bunion correctors work. You will see lots of posts and comments by podiatric and orthopedic surgeons saying that they do not work (they make their money by doing bunion surgery) and you see lots of posts and comments by people selling them say that they do work (they make their money by selling them).

So, who should you believe? Should you believe all the testimonials on the sites selling them. They can be fake. Lots of forum and social media posts ask if the work (eg here and here). Some podiatrists have tried to address the issue (eg here).

In these situations, you need to defer to what the unbiased published and peer reviewed scientific research says. Unfortunately there is not a lot to go on here as its not exactly a popular topic for researchers to look into!

There is one study that has looked at this and, yes it showed that bunion correctors do work at correcting bunions. However, it was only done over a 3 month period and its showed on average a 1 degree improvement per month in the angle of the hallux valgus. That is a reasonable outcome. What they study did not show is that if there is further improvement beyond the three months or if you need to keep wearing them to maintain the improvement. Maybe the improvement reverses when the corrector is no longer used.

There are lots of unanswered questions regarding the research on these, so unfortunately opinions is all that is left. There are opinions (eg here) that even if they do not actually correct the bunion or hallux valgus, they are still useful as a physical therapy type intervention to stretch and keep the joint mobile. This is a reasonable opinion and use of these bunion correctors.

Fat Injections Provide Long-Term Solution for Foot Pain

Press release:

PITTSBURGH – Fat grafting to the foot can provide long-lasting improvements in foot pain and function for patients suffering from pedal fat pad atrophy, or the disintegration of fat in the ball of the foot. Results of a clinical trial led by experts at the University of Pittsburgh Department of Plastic Surgery are available online and published today in the December issue of the journal Plastic and Reconstructive Surgery.

Jeff and Beth Gusenoff feature“Forefoot fat pad atrophy is common because the fat pads in the foot are used constantly for shock absorption when walking,” said lead author Jeffrey Gusenoff, M.D., professor of plastic surgery at Pitt. “We typically see this condition in patients with specific foot structures, a history of long-term aggressive activity, and those who have experienced surgery, foot trauma or multiple forefoot steroid injections.”

Gusenoff led a multidisciplinary team that included podiatry and plastic surgery clinicians as they examined 31 patients divided into two groups over a span of two years. The overall purpose of this outcomes study was to “assess whether fat grafting to the forefoot in patients with fat pad atrophy will reduce foot pressure during gait, increase the soft tissue thickness of the foot pad and ultimately reduce pain.”

All patients participating in the trial received the minimally invasive pedal fat grafting surgery, with the first group undergoing the procedure immediately with two years of follow-up and the second group managing the condition conservatively for one year and then undergoing the procedure with one year of follow-up.

Study results show that fat grafting is a safe, minimally invasive approach to treat pedal fat pad atrophy and that undergoing the procedure sooner prevents worsening symptoms that would occur as a result of conservative management. Fat grafting currently is the only minimally invasive treatment method that has proven to be effective for this condition.

“We are happy that we can finally bring relief to people who have been living with pain and a decreased quality of life,” said Gusenoff. “The positive responses we’ve heard from our patients have made all of our research worthwhile.”

Additional authors on the study were Beth Gusenoff, D.P.M., and Danielle Minteer, Ph.D., both of Pitt. This work was funded by 2013 and 2014 Plastic Surgery Foundation Pilot Research Grants, and the treatment is available at UPMC.