Therapeutic Shoes for Plantar Fasciitis

Overseen By Hafizur Rahman, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Rio Grande Valley

Must not be taking: Oral anti-inflammatories

Disqualifiers: Plantar ulcer, Major foot deformities, Amputation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 18

Duration: 6 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether OrthoFeet Hands-Free therapeutic shoes can reduce foot pain, particularly for those with plantar fasciitis. Participants will wear either their own shoes or the OrthoFeet shoes with inserts to determine which offers better relief. This trial suits individuals experiencing regular foot pain, such as heel or arch pain, who have not yet begun medical treatment. As an unphased trial, it provides a unique opportunity to explore innovative solutions for foot pain relief.

Do I need to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot be engaged in any treatment for foot pain, including oral anti-inflammatories.

What prior data suggests that these therapeutic shoes are safe for patients with foot pain?

Research shows that OrthoFeet Hands-Free therapeutic shoes help people with foot pain, such as plantar fasciitis, feel more comfortable. These shoes feature soft soles, arch support, and a roomy toe area to reduce pain and pressure.

Although specific clinical trial data on their safety is unavailable, these shoes have been sold to consumers with a 60-day wear test guarantee, indicating general user satisfaction. While not as comprehensive as clinical trial data, consumer testing can still offer some confidence in their safety and comfort for daily use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The OrthoFeet HandsFree Therapeutic Shoe is unique because it combines therapeutic comfort with ease of use, specifically designed for people suffering from plantar fasciitis. Unlike traditional treatment options like orthotic inserts, physical therapy, or pain medications, this shoe offers a hands-free design that makes it convenient to wear. The shoe provides targeted support and cushioning to alleviate heel pain, which could improve mobility and encourage more consistent use. Researchers are excited about this approach because it simplifies the treatment process, potentially enhancing patient compliance and delivering effective relief from symptoms.

What evidence suggests that OrthoFeet Hands-Free therapeutic shoes are effective for foot pain?

Research suggests that OrthoFeet shoes, which participants in this trial may receive, might help with plantar fasciitis by providing excellent arch support and cushioning. These shoes maintain proper foot alignment, potentially reducing pain and pressure on the heel. Their cushioned soles absorb shock, which might alleviate discomfort from plantar fasciitis. The shoes also feature a roomy toe area and soft materials, enhancing comfort for those with foot pain. Although specific studies on OrthoFeet's effectiveness for plantar fasciitis are lacking, the shoe design aims to relieve symptoms and improve foot comfort. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals who can consent, have normal foot sensation, and self-reported foot pain not currently under a treatment plan. It excludes those with swelling, ulcers, major foot deformities or amputations, cognitive impairments or depression, unstable medical conditions, decreased foot sensation, or those treating their foot pain.

Inclusion Criteria

Be able to give written, informed consent

In-tact protective sensation as determined using Semmes Weinstein monofilament

I am not currently following any doctor-prescribed treatment plans.

Exclusion Criteria

I have swelling.

I have an ulcer on the bottom of my foot.

I have significant foot deformities like charcot foot or high arches.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants wear OrthoFeet Hands-Free therapeutic shoes and prefabricated inserts for a 6-week intervention period

6 weeks

Baseline, 6 weeks, 12 weeks

Follow-up

Participants are monitored for improvements in foot pain, quality of life, and plantar pressure distribution

6 weeks

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• OrthoFeet HandsFree Therapeutic Shoe

Trial Overview The study tests the effectiveness of OrthoFeet HandsFree therapeutic shoes with inserts in reducing foot pain and pressure. Participants will use these specialized shoes to see if they help relieve discomfort associated with plantar fasciitis.

How Is the Trial Designed?

Group I: OrthoFeet shoe Experimental Treatment 1 Intervention

Patients wearing OrthoFeet shoes with standard inserts

Group II: Own Shoe Active Control 1 Intervention

Patients wearing their own appropriate shoes

OrthoFeet HandsFree Therapeutic Shoe is already approved in United States, European Union for the following indications:

Approved in United States as OrthoFeet Hands-Free Therapeutic Shoe for:

• Foot pain
• Plantar fasciitis
• Diabetes & Neuropathy
• Back pain
• Morton's Neuroma

Approved in European Union as OrthoFeet Hands-Free Therapeutic Shoe for:

• Foot pain
• Plantar fasciitis
• Diabetes & Neuropathy
• Back pain
• Morton's Neuroma

Who Is Running the Clinical Trial?

University of Texas Rio Grande Valley

Lead Sponsor

Trials

8

Recruited

2,700+

Published Research Related to This Trial

Plantar fasciitis affects up to 10% of people and is typically treated conservatively with methods like stretching, ice, and insoles, which are considered the gold standard.

For patients who do not improve with conservative treatments, endoscopic plantar fascia release shows a high success rate of 70% to 90%, making it an effective surgical option for chronic cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-Portal Endoscopic Plantar Fascia Release: Step-by-Step Surgical Technique. Campillo-Recio, D., Ibañez, M., Jimeno-Torres, E., et al.[2021]

In a study involving 30 adults with plantar fasciitis, two types of prefabricated foot orthotics (soft supportive foam and foam covered rigid plastic) significantly reduced pain levels compared to a non-supportive orthotic, which showed no effect.

The foam covered rigid plastic orthotic was found to be the most effective, providing superior pain reduction and quicker onset of relief compared to the soft supportive foam orthotic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of different orthotic concepts as first line treatment of plantar fasciitis. Walther, M., Kratschmer, B., Verschl, J., et al.[2022]

Customized 3D printed ankle-foot orthoses (AFOs) significantly improved comfort and reduced peak pressure in key areas of the foot for patients with plantar fasciitis compared to traditional prefabricated AFOs, as shown in a study of 60 patients over 8 weeks.

After 8 weeks, patients using the customized AFOs reported significantly greater comfort levels than those using prefabricated AFOs, indicating that customized solutions may be more effective in managing plantar fasciitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of 3D Printing Individualized Ankle-Foot Orthosis on Plantar Biomechanics and Pain in Patients with Plantar Fasciitis: A Randomized Controlled Trial. Xu, R., Wang, Z., Ma, T., et al.[2020]

In a study comparing two types of ankle-foot orthoses (AFOs) for treating plantar fasciitis, two-thirds of participants reported reduced morning pain and stiffness after using either type of AFO.

The anterior AFO was found to be more effective and comfortable than the posterior AFO, which was associated with more discomfort and sleep disruption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of two night ankle-foot orthoses used in the treatment of inferior heel pain: a preliminary investigation. Attard, J., Singh, D.[2012]

A study involving 15 patients with unilateral plantar fasciitis found that combining rocker shoes and custom-made foot orthoses significantly reduced heel pain more effectively than using either treatment alone, with a pain score of 9.7 mm compared to 30.9 mm for rocker shoes and 29.5 mm for foot orthoses.

The combination treatment also led to a greater reduction in peak pressure on the heel, decreasing it by 33.58%, which suggests that this approach not only alleviates pain but also redistributes pressure more effectively than the individual treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of combined prescription of rocker sole shoes and custom-made foot orthoses for the treatment of plantar fasciitis. Fong, DT., Pang, KY., Chung, MM., et al.[2019]

In a study of 44 patients with plantar fasciitis, those who used a night splint showed significantly greater improvements in pain relief and function after two months compared to those who did not use the splint.

Despite the short-term benefits of using a night splint, the study found no significant effect on preventing recurrences of heel pain over a two-year follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The effectiveness of dorsiflexion night splint added to conservative treatment for plantar fasciitis]. Beyzadeoğlu, T., Gökçe, A., Bekler, H.[2019]

A study involving 98 participants with plantar fasciitis showed that using both prefabricated orthotics and orthotic sandals significantly reduced foot pain and improved foot function compared to using orthotics alone.

While both treatment groups experienced pain relief and functional improvements, the combination of orthotics and sandals provided better outcomes, particularly in pain reduction as measured by the numerical rating scale.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of orthotics with orthotic sandals versus the sole use of orthotics for plantar fasciitis: Randomised controlled trial. Amoako-Tawiah, P., Love, H., Chacko Madathilethu, J., et al.[2023]

In a study involving 142 adults with plantar fasciitis, both prefabricated and customized foot orthoses made from low-cost EVA foam showed significant improvement in pain after 8 weeks of use, indicating their effectiveness in treatment.

There was no significant difference in pain relief between the two types of orthoses, suggesting that low-cost prefabricated EVA inserts are a viable and effective option for treating uncomplicated plantar fasciitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of prefabricated and customized foot orthoses made from low-cost foam for noncomplicated plantar fasciitis: a randomized controlled trial. Baldassin, V., Gomes, CR., Beraldo, PS.[2022]

In a study of 22 patients with chronic plantar fasciitis, endoscopic plantar fascia release resulted in a high satisfaction rate of 97.7%, with all patients reporting at least a 50% improvement in pain after surgery.

The procedure was particularly effective for patients without prior foot trauma and those with unilateral symptoms, as 68% of patients achieved good or excellent results according to the modified Mayo Foot and Ankle Score.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic plantar fascia release. Hogan, KA., Webb, D., Shereff, M.[2017]

Citations

1. orthofeet.com orthofeet.com/products/wander-hands-free-white?srsltid=AfmBOopqW0e1mrTur81p81pp3XQKY83nf_-pAfbwK7kvL7WTas2xJg3L

Wander Hands-Free - White Get instant comfort & pain relief. Premium arch support, cushioning soles, soft uppers & wide toe box. 60-day wear test. Free shipping & returns.

2. orthofeet.com orthofeet.com/products/nira-hands-free-black?srsltid=AfmBOoonwccNh7M7O9bM8NpNR9sToMVaPeW6febv87TenE5UOV_zBCLn

Nira Hands Free - Black Orthofeet shoes have arch support to align the foot and multi-cushioned soles to absorb impact. This helps alleviate fascia pain and pressure points at the heel ...

3. orthofeet.com orthofeet.com/products/nira?srsltid=AfmBOor1vqyHV7O3CSmzIJSE_DpLfMI31iCt2g4BfmFWz_IZVF4wxdzQ

Nira Nira takes your active, pain-free comfort to the next level in modern sneaker style. With our patented hands-free technology, you can skip the laces.

4. amazon.com amazon.com/Orthofeet-Orthopedic-Hands-Free-Tilos-Sneakers/dp/B0DCHNMBL6

Orthofeet Men's Orthopedic Hands-Free Tilos Slip-On ... Orthofeet shoes have unmatched cushioning and benefit 20+ conditions including foot and heel pain, plantar fasciitis, diabetes, arthritis, bunions, achilles ...

5. orthofeet.com orthofeet.com/products/wander-hands-free-camel?srsltid=AfmBOooN3Rf0PZm6c04q3fz_4mq-hSdjMUAoLiz_1sjkZosn7AvX932D

Wander Hands-Free - Camel Mild rocker sole design propels your foot forward naturally, reducing muscle strain and energy expenditure; Advanced ergonomic design reduces foot fatigue that ...

6. orthofeet.com orthofeet.com/products/nira?srsltid=AfmBOooSbnm2EaW62elQc_VyI07VYnbO7Cu3z74tOPEv-KCqxFA2iqU5

Nira Nira takes your active, pain-free comfort to the next level in modern sneaker style. With our patented hands-free technology, you can skip the laces.

7. orthofeet.com orthofeet.com/products/wander-hands-free-white?srsltid=AfmBOor04yaMywFGxUZwL9oIxoGcRt_D-WsnE_q22-l1o2c7Ww6FW2E4

Wander Hands-Free - White Get instant comfort & pain relief. Premium arch support, cushioning soles, soft uppers & wide toe box. 60-day wear test. Free shipping & returns.

8. orthofeet.com orthofeet.com/products/tilos-hands-free-black-black?srsltid=AfmBOop4LwzSDyTKg0zu0oglzV4aKWMogFr5EUJUodP5ZiqmLT-2vIk3

Tilos Hands Free Shoe - Black/Black The Tilos Hands-Free shoe offers max cushioning, slip-on ease, is water-repellent, has an orthotic insole, arch support, and fitting spacers for a secure fit.

9. amazon.com amazon.com/orthofeet-nira-hands-free-women/s?k=orthofeet+nira+hands+free+women

Orthofeet Nira Hands Free Women OrthoComfoot Women's Orthopedic Diabetic Wide Walking Shoes: Comfortable Casual Arch Support Plantar Fasciitis Sneakers,. More ...

10. orthofeet.com orthofeet.com/products/nira-hands-free-black?srsltid=AfmBOooBrFHWrq20ZKN_asVDQoAytfOYGVo8mGz8zQdMOfiWLA2esTEr

Nira Hands Free - Black Orthofeet shoes have arch support to align the foot and multi-cushioned soles to absorb impact. This helps alleviate fascia pain and pressure points at the heel ...