Clinical Trials Updates

NewsBot · Feb 16, 2023

Randomized Controlled Trial of Remote Foot Temperature Monitoring

Diabetic foot ulcers are common, debilitating, and costly complications of diabetes, disproportionately impacting Black and rural Veterans. Forty percent of individuals have an ulcer recurrence within a year of ulcer healing and 65% within 5 years. Monitoring plantar foot temperatures is one of the few interventions that reduces the risk of ulcer recurrence. Despite the evidence, adoption has been poor because the original procedures, including the use of handheld thermometers, were burdensome and time-consuming. Podimetrics, a private company, has developed a temperature monitoring system involving a "smart" mat that can wirelessly transmit data and a remote monitoring team that works with VA providers to assist with triage and monitoring. This care model has incredible promise, but has been untested in VA. The investigators propose to conduct a randomized trial to evaluate effectiveness of remote temperature monitoring as well as costs. Additionally, the investigators will evaluate the implementation process, including barriers and facilitators to use among key stakeholders.
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NewsBot · Feb 19, 2023

Plantar Pressure Values in Patients With Ankylosing Spondylitis

this study was discovered that clinical and radiological characteristics were related to plantar pressure assessments in patients with AS.
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NewsBot · Feb 22, 2023

The Effect of Combined Red and Infrared Lasers on Histopathology Collagen Formation in Diabetic Foot Ulcer (wounds)

Objective: investigate The effect of combined red and infrared lasers on histopathology collagen formation in diabetic foot ulcer Participants: The forty five patients will assigned randomly into three equal groups, each group consist of 15 patients, group A received laser therapy in sequential mode, group B received laser therapy in separate mode and the control group C receive conventional wound care treatment
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NewsBot · Feb 24, 2023

Medial Wedge Insoles to Improve Gait in Persons After Total Hip Replacement - Randomized Control Trial

The study will test the hypothesis, that the use of medial wedge insoles in people participating in comprehensive rehabilitation between 1-6 months after total hip replacement, and not having a varus deformity of the knee or symptomatic arthrosis of the medial knee compartment, will improve patient's functioning, the symmetry of gait and stance compared to persons using sham insoles.

The participants will undergo a 6-week program of in-patient rehabilitation aimed at: pharmacologic and non-pharmacologic pain management, improvement of vascular function, cardiopulmonary function, functions of skeletal muscles, range of motion and stability of peripheral joints, gait function, body position. The rehabilitation program will also address individual needs with psychotherapy and vocational therapy.

The study will help to identify correlations between gait parameter change and functional improvement during the rehabilitation following THR.

Study participants will be provided with individually made corrective medial wedge insoles or sham insoles and instructed to use them during gait training and everyday activities.

Functional parameters will be examined at the study entry, at the end of 6 weeks of intervention, and 6 weeks following discharge.
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NewsBot · Feb 27, 2023

Calcaneal Low Dye Taping Plantar Fascial Stretching and Sham Taping in Football Players

Showing the effect of calcaneal Low-dye Taping on acute planter heel pain and functional activity level in football players.
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NewsBot · Feb 28, 2023

Effectiveness of Buerger Allen Exercise Among Type 2 Diabetes Mellitus Patients With Foot Ulcer

This study was conducted to determine the effect of Buerger Allen exercises on lower extremity perfusion and wound healing in patients with foot ulcer type 2 diabetes. The Buerger Allen exercise is a specific exercise that aims to improve circulation in the feet and legs. Buerger Allen exercise is an ideal and noninvasive therapy for diabetic patients with a diabetic foot ulcer as it is an easy-to-learn, repetitive, low-cost, and low-risk physical activity. Subjects were randomly allocated to either the control or intervention group. The ulcers and lower extremity perfusion of the patients in both the intervention and control groups were examined and measured.
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NewsBot · Mar 7, 2023

Foot Core Exercise Program on Balance Control and Walking in Aged Sarcopenia

In modern society with an increasing aging population, recent literature has defined sarcopenia as a significant reduced mass and function of skeletal muscle with physical limitations due to aging. Clinically and experimentally, the foot often plays a crucial role in sensorimotor control and movement performance in standing, walking, and running. Apparently, previous literature has shown that the intrinsic and extrinsic foot muscles have significantly reduced muscle morphology and muscle strength in the elderly compared to that of young healthy controls. How to effectively increase foot muscles using muscle-strengthening exercises will be a crucial issue for further research and clinical intervention in this population.

The intrinsic foot muscles (IFM) are the primary local stabilizer to provide static and dynamic stability in the foot, which are part of the active and neural subsystems to constitute the foot core system. The intrinsic foot muscles (IFMs) may play a key role in supporting foot arches (e.g., the medial longitudinal arch, MLA), providing flexibility, stability, shock absorption to the foot, and partially controlling foot pronation. Due to the difficulties in teaching and learning the plantar intrinsic foot muscle (IFM) exercise, the accuracy and follow-up after learning this exercise could be questioned following this exercise program. Physiologically, the effects of integrated exercise intervention may be achieved following more than 4-week intensive exercise intervention at least. How to learn and activate this kind of exercise efficiently and effectively is a key issue for employing these exercise interventions in the elderly with and without sarcopenia.

In this project, we will aim to employ the novel intrinsic foot muscle strengthening device using 3-D printing techniques and to examine the feasibility and reliability of the morphology in intrinsic and extrinsic foot muscles and foot posture before and after exercise intervention using sonographic imaging and foot posture index in the elderly with and without sarcopenia; second, we will investigate whether the immediate and persistent increase in balance control and level-walking after this therapeutic exercise with novel 3-D printing foot core exerciser.
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NewsBot · Mar 14, 2023

Low Dye Taping Technique and Temporary Felt Insoles on Pain and Disability in Children With Pes Planus.

This study aims to determine comparative effects of low dye taping technique and temporary felt insoles on pain and disability in children with pes planus.
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NewsBot · Mar 14, 2023

Treatment of Lower Leg Anterolateral Chronic Exertional Compartment Syndrome With Intra-muscular Botulinum Injections.

The goal of this pilot triple-blind randomized clinical trial is to determine the effectiveness of intra-muscular botulism injection for treatment of lower leg anterolateral chronic exertional compartment syndrome (CECS).
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NewsBot · Mar 17, 2023

Low-Level Laser Therapy for Plantar Fasciitis

Plantar fasciitis (PF), a degenerative injury of the connective tissue in the foot, results in pain-related disability in Service Members and contributes to decreased physical activity and excessive healthcare costs. Even if effective, current treatment protocols may require 6-12 months of therapy to return individuals to pain-free activity. Photobiomodulation therapy (PBMT) uses non-ionizing light to elicit biological changes in tissues resulting in beneficial therapeutic outcomes. Evidence supports use of PBM for other degenerative connective tissue conditions, such as achilles tendinopathy and epicondylitis. A previous pilot study was completed in an active-duty military and civilian population, which demonstrated a positive effect of two PBM dose parameters on function and pain levels in participants with chronic PF when combined with stretching and ice. These positive findings from the aforementioned study are promising in the treatment of this common and debilitating issue, but require the addition of a sham comparison to rigorously eliminate any potential placebo effect of the treatment protocol, and further refine the treatment protocol in order to make evidence-based clinical recommendations. As such, proposing a follow-up study and the addition of an objective outcome measure will strengthen the impact of the study.

SPECIFIC AIM 1: To assess the clinical effectiveness of photobiomodulation compared to sham photobiomodulation to improve function and decrease pain.

SPECIFIC AIM 2: To evaluate the effectiveness of photobiomodulation compared to sham photobiomodulation to resolve plantar fascial thickening. DESIGN: A prospective randomized sham-controlled trial to meet the aims of the study.

METHOD: A sample of up to 100 active-duty military members will be randomly assigned to the Sham-PBMT or PBMT group. At baseline, during the treatment protocol, and at long-term (3 and 6 months) follow-up, measures of foot function, pain, and plantar fascial thickness will be collected for analysis. The proposed methods will allow the study team to establish if PBMT is clinically effective to accelerate recovery compared to Sham-PBMT and result in resolution of fascial thickening, decrease in pain, and improved function.

LONG-TERM GOAL: The long-term goals of the research include developing PBMT protocols for broad application to other painful and duty-limiting conditions.
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NewsBot · Mar 20, 2023

Diabetic Foot Ulcer Research Study

The goal of this clinical trial is to compare safety and performance of the study device to the current typical NHS standards of care device. The main outcomes it aims to achieve are:

Complete wound healing at 12 weeks (100% epithelialised)

% Reduction in wound area at 12 weeks

Participants will attend their NHS podiatry clinic appointment as normal and will be assigned either the study device or the current typical NHS standard of care device. Researchers will compare the study device group to the standard group to assess the outcomes mentioned previously.
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NewsBot · Mar 21, 2023

Instrument-Assisted Soft Tissue Mobilization on Gastrocnemius and Achilles Tendon in Plantar Fasciitis

Aim of this study is to compare the effects of instrument assisted soft tissue mobilization on gastrocnemius and Achilles tendon on pain,range of motion and foot disability.A randomized control trial that will include total 32 participants and divided into two groups.Patients in Group A will receive instrument assisted soft tissue mobilization of gastrocnemius and Group B will receive instrument assisted soft tissue mobilization of Achilles tendon. While conventional therapy will be given to both groups.Data collected will be analyzed through SPSS 25.
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NewsBot · Mar 22, 2023

Effect of Myofascial Release in Addition to Foot Core Exercises in Young Adults With Asymptomatic Flexible Pes Planus

Pes planus is a foot deformity characterized by a low medial longitudinal arch. It is more common in young adults. With low arch, tension occurs in the plantar fascia. Fascia and soft tissue loading may lead to different musculoskeletal problems such as plantar fasciitis, medial tibial stress syndrome, patellofemoral disorders and back pain. In addition, pes planus can affect individuals' activities of daily living, productivity in occupational settings, and injury risk and performance in sports.

Treatment of pes planus includes strengthening, stretching, taping and orthotics for the foot muscles. Among these applications, strengthening of the foot core muscles is one of the most common and effective methods. By strengthening the foot core muscles, it is aimed to reduce the effect of the kinetic chain. Pes planus is a postural deformity that affects the kinetic and fascial chain, but the treatment program is usually planned regionally. With fascial continuity and fascial conduction, the tension on the plantar fascia in pes planus affects the gastro-soleus, peroneus longus and brevis, hamstring muscles, iliotibial band and thoracolumbar fascia. Stretching of the plantar fascia, which is included in current treatment programs, has only a local effect and thus cannot prevent fascial chain involvement. Myofascial release, one of the methods used to reduce the tension in the fascia, has been used frequently in recent years. Myofascial release is performed with methods such as manual, foam roller and instrument assisted release. Foam roller (cylinder foam) is a practical myofascial release method that can be self-applied by the individual.

In addition to strengthening the intrinsic muscles of the foot in individuals with pes planus, it has been reported that fascial chain involvement should also be taken into consideration due to the tension in the plantar fascia with low arch. This study was planned to investigate the effect of myofascial release methods on lower extremity performance in addition to foot core exercises used effectively in the treatment of pes planus.
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NewsBot · Mar 23, 2023

Effects of Foot Exercises and Hydrotherapy on Pedal Edema & Lower Extremity Function

To determine the Effects of foot exercises with and without hydrotherapy on pedal Edema & lower extremity function in antenatal women.
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NewsBot · Mar 23, 2023

5 Year Radiological and Clinical Results From Patients Operated for Hallux Valgus Deformity.

Retrospective study of patients operated for hallux valgus deformity at our hospital (ostfold hospital trust) 5 years ago. Patients will be clinically examined, a weighted radiograph of the foot (traditional and newer parameters will be evaluated) and patient reported outcome measures (PROM) scores will be collected.
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NewsBot · Mar 28, 2023 at 2:24 AM

A Mobile Recovery Guidance App for Children and Young Adults With Acute Ankle Inversion Injuries (SPRAIN)

Ankle sprains are the most common musculoskeletal complaint of children presenting to the emergency department (ED). Healing can often be protracted, leading to prolonged pain, missed school and work, and delayed return to a normal activity level. Smartphone apps have been shown to be associated with greater caregiver knowledge and improved outcomes in a number of conditions but have not been explored in ankle sprains. We would like to know if using a smartphone app for children with ankle inversion injuries leads to improved functional outcomes such as pain, mobility, and return to activity. We will be comparing a smartphone app that provides education and daily management reminders to a paper handout to see if the former leads to improved functional recovery.
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NewsBot · Mar 30, 2023 at 5:45 AM

Effects of Dynamic Balance Exercise on Flexible Pes Planus (PesPlanus)

The purpose of this study is to investigate the effects of intrinsic strengthening and dynamic balance exercises in patients with flexible pes planus. Forty-five participants aged 18 to 35 years were enrolled in the study, and the first group underwent intrinsic foot muscle strengthening training with short foot exercises (SFE) and used insoles. The second group trained using the dynamic balance board, which promotes dynamic balance and used insoles. The third group used only insoles. The total duration of treatment was 8 weeks/3 days. The degree of foot deformity was assessed with the, medial longitudinal arch (MLA) angle, measurements of subtalar angle and navicular drop test. Foot position assessed using Foot Posture Index (FPI) Static balance was assessed with the Flamingo Balance Test and dynamic balance with the " BOBO Health Platform with Gaming®" device.
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Clinical Trials Updates

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Discrepeances in foot related clinical trials between registration and publications

Sham or placebo foot orthotics for use in clinical trials

"sham" foot orthoses and clinical trials

Timing and Completeness of Trial Results Posted at ClinicalTrials.gov and Published in Journals

What outcomes are important in clinical trials

Western clinical trials bad for traditional medicine

Clinical trials involving footwear & orthotics

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Clinical Trials Updates

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Discrepeances in foot related clinical trials between registration and publications

Sham or placebo foot orthotics for use in clinical trials

"sham" foot orthoses and clinical trials

Timing and Completeness of Trial Results Posted at ClinicalTrials.gov and Published in Journals

What outcomes are important in clinical trials

Western clinical trials bad for traditional medicine

Clinical trials involving footwear & orthotics

Share This Page

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