Clinical Trials Updates

NewsBot · Nov 14, 2023

Comparison of the Effects of Two Different Orthoses on Individuals With Hallux Valgus

Hallux valgus (HV) is a tri-planar, painful and common foot deformity characterized by the medial orientation of the first metatarsal, lateral deviation and pronation of the big toe at the level of the first metatarsophalangeal joint. Due to the increase in the severity of hallux valgus deformity, dissatisfaction with the appearance of the foot, difficulty choosing shoes due to bunions and pain, difficulty walking and accordingly, restriction in daily activities, the functional levels and health-related quality of life of individuals are negatively affected. The aim of this study is to compare the effect of using a toe separator orthosis and dynamic orthosis for 1 month on hallux valgus angle and plantar pressure in individuals with hallux valgus.
Click to expand...

NewsBot · Nov 18, 2023

Hamstring Stretching in Plantar Fasciitis

The purpose of the study is to compare the effects of Hamstring stretching versus conventional treatment for plantar fasciitis. A randomized control trial was conducted at Cena Medical Center Rawalpindi and Midland Doctors Institute Muzaffarabaad. The sample size was 64 calculated through open-epi tool. The participants were divided into two groups, interventional and control group each having 32 participants. The study duration was 1 year. Sampling technique applied was Purposive sampling for recruitment and group randomization using flip coin method. Only 25to 45 years participants with plantar fasciitis along with hamstring tightness were included in the study. Tools used in this study are Goniometer, Visual Analogue Scale(VAS) for pain, and Functional Foot Index (FFI) for pain and disability. Data was collected before treatment at baseline and after 1st and 2nd week of the application of interventions. Data analyzed through SPSS version 25.
Click to expand...

NewsBot · Nov 19, 2023

Effects of Active and PRT on Pain, Function and Temporospatial Gait Parameters in Runners With Plantar Fascitis

The study is randomized and single -blinded. Ethical approval is taken from ethical committee of Riphah International university Lahore.Participants who will meet criteria will be requested to give verbal consent and to sign written consent form. After signing consent form participants will be allocated to the group A and Group B by using computerized generated randomization. Group A will receive ultrasound then Active release technique while group B will receive ultrasound and Positional release technique for 4 weeks. Treatment sessions will be 12 sessions, 3 sessions per week on alternative days for 4 weeks
Click to expand...

NewsBot · Nov 27, 2023

Clinical Efficacy of Different Revision Times in the Reulceration Rate in Persons With Diabetes and Remission (Diatime)

The goal of this three arms randomized clinical trial is to compare different revision times in persons with diabetes at high risk of suffering a diabetic foot reulceration (patients in remission). The literature suggests to clinically check the patients in a 4-6 weeks basis, despite this, this recommendation is based in expert opinions.

The main question it aims to answer is:

- Does different revision times could affect the reulceration rate in persons with diabetes in remission. Different revision time will be 2 weeks, 4 weeks and 6 weeks.
Click to expand...

NewsBot · Nov 30, 2023

Corrective Calcaneal Kinesiology Tape in Adolescents With Pronated Foot

The aim of this study is to find the effect of a program of corrective kinesiotaping on pain intensity, foot function, and the sonographic picture of plantar fascia in adolescents with pronated feet.This study hypothesizes that there will be a statistically significant effect of a program of application of the corrective technique of kinesiotaping on plantar heel pain, foot function, and the sonographic picture of plantar fascia in a sample of Egyptian adolescents suffering from pronated feet.
Click to expand...

NewsBot · Dec 11, 2023

Immune Cells in Diabetic Chronic Foot Ulcers

The goal of this observational study is to learn about the role of immune cells in patients with diabetes and chronic foot ulcers. Researchers will compare blood and tissue samples of patients with diabetes and a foot ulcer that is healing or healed compared to those diabetic patients where the foot ulcers is not healing (chronic ulcer).
Click to expand...

NewsBot · Dec 18, 2023

Comparing Two Protocols of Shock Wave Therapy for Patients With Plantar Fasciitis

The goal of this clinical trial is to compare the efficacy of two distinct shock wave therapy protocols and their impact on improving function and reducing pain in individuals with plantar fasciitis, a common cause of heel pain that affects millions worldwide.

The key questions the study aims to address are:

How effective is each shock wave therapy protocol in enhancing functional ability without pain in patients with plantar fasciitis? Does either protocol offer a significant benefit over the other in terms of pain relief and functional improvement after a course of six treatment sessions?
Click to expand...

NewsBot · Dec 20, 2023

A Study to Assess EN3835 in the Treatment of Plantar Fasciitis (PFA)

This study will assess the efficacy, safety, and tolerability of 2 different doses of EN3835 compared to placebo.
Click to expand...

NewsBot · Dec 22, 2023

Pain Improvement After Ultrasound Guided Continuous Radio Frequency 60 Degree for Plantar Fasciitis

detailed changes after ultrasound guided cry for plantar fasciitis in regard pain score and plantar fascia AP diameter in ultrasound scan pre and 30 days post operation
Click to expand...

NewsBot · Dec 22, 2023

Evaluation of a Combination of Two Medical Devices and One Device Use in the Treatment of Toenail Onychomycosis

The goal of this clinical investigation is to evaluate the efficacy of the tested products in medium to moderate onychomycosis after 112 days of treatments.

The main question it aims to answer is the effectiveness of the use of a combination of two investigational devices (Sérum PURIFIANT + Sérum BOOSTER) on the percentage of healthy nail surface after 112 days of treatment.

Participants will apply one or two devices on the affected toenail during the study.

Patients included on the groupe 1 will use Sérum PURIFIANT only, twice daily.
Patient included on group 2 will use Sérum PURIFIANT, twice daily associated with Sérum BOOSTER twice weekly.
For this investigation, 44 patients (22 patients per group) presenting at least one infected toenail will be included to reach this objective.
Click to expand...

NewsBot · Dec 24, 2023

Plantar Fasciitis Management on Postural Control

Foot pain is common in the general population. Plantar fasciopathy may affect 7% of the population at some time in their lives, but the incidence increases with age. This plantar problem is characterized by severe pain under the foot (at plantar level), which can be very incapacitating and disabling. This can lead to absenteeism from work, particularly for employees working in a standing posture. Various therapeutic avenues can be used to reduce pain and improve functionality, such as physiotherapy, infiltrations and surgery. In this research project, the propose the use of a conservative approach through the use of foot orthoses, which appears to be effective in reducing pain. The aim of the study is thus to better understand the effect of foot orthoses on postural balance and walking in workers with plantar fasciopathy. Participants will be assessed at baseline and eight weeks later to observe measured changes and clinical improvements following orthotic wear. Balance and gait pattern will be assessed using technological tools that have been validated in this respect. Participants will also be asked about their pain intensity. The hypothesis is that wearing the orthosis will improve the participants' balance and walking abilities, as well as reduce the level or intensity of their pain. In addition, this study could have an impact on the rate of absenteeism from work from current context of labour shortages.
Click to expand...

NewsBot · Dec 28, 2023

Foot Spine Syndrome "RAFFET Syndrome"

case series aimed to describe a new clinical condition for the first time in the medical literature called Foot Spine Syndrome or "RAFFET Syndrome". This syndrome was reported in 11 patients (6 males and 5 females) out of 4000 patients with a history of chronic low back pain (CLBP) throughout 2 to 6 years in an outpatient clinic in Egypt from 2016 to 2022.
Detailed Description
Foot pain is usually derived from systemic disorder or local physical issues, such as tendonitis, arthritis, or bursitis. However, in some cases, pain in your foot may be linked to problems in your spine. This case series aimed to describe a new clinical condition for the first time in the medical literature called Foot Spine Syndrome or "RAFFET Syndrome". This syndrome was reported in 11 patients (6 males and 5 females) out of 4000 patients with a history of chronic low back pain (CLBP) throughout 2 to 6 years in an outpatient clinic in Egypt from 2016 to 2022. The patients suffered from CLBP that did not respond to physical therapy or any medication for long. They all had clinical spinal instability, hallux rigidus, foot abnormalities and tightness of hip flexors and adductors accompanied with weakness of hip extensors and abductors on the affected side. Manual therapy for the big toe including; Maitland mobilization (Grade 3,4), Mulligan mobilization with movement techniques, muscle energy techniques, manual therapy for plantar fascia, strengthening exercises and self-stretching exercises was performed.
Click to expand...

NewsBot · Dec 28, 2023

AM for Refractory Achilles Tendinopathy

To evaluate outcomes after use of micronized amniotic membrane to replace or supplement damaged or inadequate integumental tissue in patients with "chronic" insertional or non-insertional Achilles tendinopathy that remains refractory to standard care. Outcomes between a control and treatment group in this pilot study will be used to devise a multi-center study with larger sample size.
Click to expand...

NewsBot · Jan 4, 2024

Effectiveness of Musicotherapy in Reducing Pain Induced by Leg Ulcer Care (MUS-ICAT)

Venous leg ulcer is the final stage of chronic venous disease and only develops due to advanced chronic venous insufficiency. The problems caused by venous disease are initially minor and often neglected, but can impact the quality of life of patients.

The prevalence of leg ulcers is estimated at 1% of the general population and 3% to 5% of subjects over 65 years old. Its prevalence increases with age in both men and women.

Managing chronic ulcers requires a certain number of care procedures, including debridement.

The act of treatment by mechanical debridement is little relieved by the analgesics given beforehand, and can be painful, with risks of bleeding.

Musicotherapy, particularly the U-shaped method, has shown its effectiveness in the treatment of pain and anxiety in several areas (geriatrics, intensive care, rheumatology, oncology, etc.).

The standardized musicotherapy method of the U-shaped sequence was developed and initially evaluated by clinical studies coordinated by the INSERM unit U1061 (Pr. Jacques Touchon; Dr. Stéphane Guétin).

Following the publication of numerous controlled, randomized studies presenting results on the effectiveness in the treatment of pain and anxiety, a digital application was developed in order to standardize the method. The Music Care health application is now a Class 1 Medical Device, with CE marking obtained.

This "U-shaped sequence" is standardized and has been clinically validated, which makes Music Care a unique tool available for pain relief.

No studies have been found in the literature regarding the use of music therapy during debridement care.
Click to expand...

NewsBot · Jan 5, 2024

Ulcer Location and Debridement Frequency: Weekly vs. Biweekly Sharp Debridement in Diabetic Foot Ulcers

The goal of this clinical trial is to determine the optimal frequency for sharp debridement in promoting the healing of diabetic foot ulcers (DFUs).

The main questions it aims to answer are:

What is the comparative effect of weekly sharp debridement versus biweekly sharp debridement in combination with conventional treatment on granulation tissue and healing time in patients with DFUs?
What is the optimal modality or frequency of debridement based on the location of the DFU?
Participants (ulcerated diabetic patients) will:

Undergo sharp debridement on a weekly basis (Group A).
Undergo sharp debridement on a biweekly basis (Group B).
Researchers will compare Group A (weekly sharp debridement) with Group B (biweekly sharp debridement ) to see if the frequency of sharp debridement has a significant effect on granulation tissue and healing time in diabetic foot ulcers.

In each group, there will be patients with ulcers in different locations (toes, metatarsal heads, and midfoot/hindfoot) to assess the effect of debridement based on the lesion location
Click to expand...

NewsBot · Jan 6, 2024

The Foot Posture and Falling Risk in Older People

This research will be conducted to examine the relationship between the foot postures and fall risks of elderly individuals living in nursing homes, to identify the factors that most affect the risk of falling, and to inform healthcare professionals working on this subject.

Factors that may increase the risk of falling will be determined from the biomechanical changes that occur in the foot with age. In addition, the results we obtain will contribute to the database to be created in the future to identify factors affecting the risk of falling.

Detailed Description
The aim of this study is to examine the relationship between foot postures and fall risks of elderly individuals living in nursing homes, to identify the factors that most affect the risk of falling and to inform healthcare professionals on this subject.

Participants included in the research will be grouped in three ways according to their gender, disease status and whether they use medication or not. The disease conditions of the participants will be handled in two ways: direct and indirect disease groups due to falls.

The researchers will evaluate the cognitive status of the participants with the Standardized Mini Mental State Test, balance and fall risks of the participants with the One Leg Standing Test and the 8 Step Up and Go Test and foot postures of the participants with the Foot Posture Index.

A power analysis was conducted to determine the number of participants required for the research. According to the power analysis result; It was found that the minimum number of participants required to be included in the study for one-way analysis of variance with an effect size of 0.3, α= 0.05, and 85% power was 126.

Ethics committee approval for the research was received by the researchers from Ankara Yıldırım Beyazıt University Health Sciences Ethics Committee on 05.01.2020 with research number 2020-600. Later, the researchers made the necessary applications to conduct this study in Karadeniz Ereğli İzmirlioğlu Nursing Home, affiliated with the Zonguldak Provincial Directorate of Family and Social Services.

However, due to the Covid-19 pandemic that affected the whole world, permission approval for the study for the Karadeniz Ereğli İzmirlioğlu Nursing Home was given to the researchers by the Zonguldak Provincial Directorate of Family and Social Services on January 21, 2022. In the preliminary examination conducted by the researchers, it was determined that the number of people required to be included in the study could not be reached from only one nursing home.

For this reason, the researchers again applied to Ankara Yıldırım Beyazıt University Health Sciences Ethics Committee with the request to add new nursing homes to the study.

In order to expand the scope of the research and conduct it in Zonguldak Center and Çaycuma Nursing Homes, a new ethics committee permission was obtained with the decision of Ankara Yıldırım Beyazıt University Health Sciences Ethics Committee dated 09.06.22 and numbered 10/960.

Later, the researchers made the necessary applications to conduct this study in Zonguldak Center and Çaycuma Nursing Homes affiliated with the Zonguldak Provincial Directorate of Family and Social Services.

Permission approval to conduct the study in Zonguldak Center and Çaycuma Nursing Homes was given to the researchers by the Zonguldak Provincial Directorate of Family and Social Services on August 11, 2022. Participants who meet the inclusion and exclusion criteria, aged 65 and over, living in Zonguldak Center and Çaycuma Nursing Home, will be included in the research.
Click to expand...

NewsBot · Jan 6, 2024

Ulcer Location and Debridement Frequency: Weekly vs. Biweekly Sharp Debridement in Diabetic Foot Ulcers

Brief Summary
The goal of this clinical trial is to determine the optimal frequency for sharp debridement in promoting the healing of diabetic foot ulcers (DFUs).

The main questions it aims to answer are:

What is the comparative effect of weekly sharp debridement versus biweekly sharp debridement in combination with conventional treatment on granulation tissue and healing time in patients with DFUs?
What is the optimal modality or frequency of debridement based on the location of the DFU?
Participants (ulcerated diabetic patients) will:

Undergo sharp debridement on a weekly basis (Group A).
Undergo sharp debridement on a biweekly basis (Group B).
Researchers will compare Group A (weekly sharp debridement) with Group B (biweekly sharp debridement ) to see if the frequency of sharp debridement has a significant effect on granulation tissue and healing time in diabetic foot ulcers.

In each group, there will be patients with ulcers in different locations (toes, met
Click to expand...

NewsBot · Jan 12, 2024

FOOTSAK (Footwear Self-Assessment Kit)

FOOTSAK is a Footwear Self-Assessment Kit intended to empower people with diabetes by providing the necessary tools and instructional materials to enable self-assessment to determine whether footwear has adequate length and width. This feasibility study aims to determine whether people with diabetes and their footwear buddies can use FOOTSAK with sufficient (1) accuracy, (2) reliability and (3) ease of use to identify incorrectly fitting footwear (IFF).

Ten people with type 1 or 2 diabetes without any minor or major toe or foot amputation will be recruited to use the FOOTSAK. Given that foot measurements have to be made whilst standing (to ensure full blood flow to feet during measurements), ten 'Footwear buddies' - will also be recruited. These are people with or without diabetes willing to measure the feet of participating people with diabetes (for example, a spouse, partner, carer, friend, neighbour, or housemate).

Both participants are asked to watch instructional videos/short demonstrations and read large text instructions. Footwear buddies are asked to repeatedly measure the feet of people with diabetes. People with diabetes are asked to repeatedly measure their footwear then assess whether they are correctly fitting. The feet and footwear of participants with diabetes are then measured by a trained researcher to determine accuracy.

Determine whether foot measurements made by footwear buddies are accurate: +/- up to 5mm when compared to a trained researcher.
Determine whether repeated footwear and foot measurements made by participants are reliable: Intraclass Correlation Coefficient ≥0.83 for footwear length and ≥0.72 for footwear width (assuming a 15% decrease in reliability when compared to a trained researchers' scores).
Determine whether FOOTSAK measuring tools and instructional materials ease of use ≥7.0 /10.0 using Visual Analogue Score with free text comments. Any measuring tool failing to obtain a score of 7.0 or higher will be replaced in consultation with PPI participants and any instructional tool amended through PPI.
Click to expand...

NewsBot · Jan 12, 2024

Effects of SMART VS FIRE Training in Chronic Ankle Instability

The study will be a randomized clinical trial with the sample size of 26. The study will be conducted at Sports Club Sheikhupura. Subjects will be enrolled according to eligibility criteria. Patients will be divided into two groups, each with 13 patients. Group A will receive SMART training intervention and warm-up exercises, while group B will receive Foot intensive rehabilitation exercises (FIRE) and warm up exercises. The session will be around 45 to 60 min on each patient with three sessions per week on alternate days. A total of Three weeks treatment regime will be given to the patients and assessment of patient's strength (CAIT) and performance (FAAM) will be done at the baseline, after the completion of treatment at three weeks and after six weeks to observe the long-term effects.
Click to expand...

NewsBot · Jan 13, 2024

Effects Of Ankle Mobility Exercises And Heel Drop Training In Planter Fasciitis

Planter fasciitis is a common cause of heel pain in adults. Planter fasciitis is frequently seen among athletes playing various sports. However, it is more prevalent in professional runner. The Biomechanical stresses including the increase in the intensity, frequency or the time frame of weight bearing activities that subject athlete's feet to continuous impact loads, surfaces with inadequate cushioning or improper shoe replacement are some of extrinsic risk factors associated with planter fasciitis.3-D ankle mobility exercises are improvised for treatment of plantar fasciitis, these comprise D2 diagonal PNF leg patterns, comprising of flexion-abduction-internal rotation and extension-adduction-external rotation. Heel drop exercise training is another useful intervention used for treating PF; the protocol consists transferring their body weight onto the forefoot of their dominant legs while slightly flexing their ankles. To get back to baseline, the non-dominant leg is given more weight, and the dominant leg's knee was remained fully extended to maintain higher gastrocnemius activation.

A Randomized clinical trial will be conducted at Pakistan Sports Board and Boston Physiotherapy Clinic Lahore through consecutive sampling technique on patients which will be allocated through opaque sealed enveloped into Group A and Group B. Group A will be treated with 3-D ankle mobility exercises and Group B will be treated with eccentric heel drop training. Outcome measures tools will be conducted through NPRS, Foot and Ankle Ability Measure (FAAM) and The VISA-A questionnaire: An index of the severity of Achilles tendinopathy after four weeks. Data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.
Click to expand...

NewsBot · Jan 15, 2024

The Effect of Capacitive and Resistive Electric Transfer Therapy in Functional Ankle Instability Patients

The goal of this clinical trial is to compare the applicability and effectiveness of capacitive and resistive Electric transfer (CRET) therapy in combination with traditional functional training in improving ankle function, proprioception, and balance in patients with functional ankle instability (FAI). The main questions it aims to answer are:

Can CRET therapy expedite the rehabilitation process for patients with functional ankle instability?
Does the combination of CRET therapy and functional exercises yield superior efficacy to other interventions?
The study included 45 participants (27 males and 18 females) with unilateral ankle instability who regularly engaged in physical activity. The participants were randomly assigned to one of four groups: a control group, a functional training group (Group F), a physiotherapy group (Group C), and a functional physiotherapy + functional training group (Group C+F). The control group did not receive any intervention to ensure comparability between groups, while the F and C+F groups performed the same movements. The C and C+F groups were standardized to use the capacitive mode first, followed by the resistive mode.
Click to expand...

NewsBot · Jan 16, 2024

TRAUMED - a Clinical Trial in Acute Ankle Sprain (TRAUMED)

TRAUMED - a randomized clinical trial evaluating the efficacy and safety of Traumed® gel in patients with acute ankle sprain.
Detailed Description
Lateral ankle sprains are the most prevalent musculoskeletal injuries in physically active populations. They also have a high prevalence in the general population and pose a substantial healthcare burden. The injury mechanism is characterized by a high velocity inversion and internal rotation of the ankle/foot complex. The treatment for acute lateral ankle sprain is quite variable, with many patients returning to activity in a short period of time; however, half of the affected population may never seek initial care. Inadequate treatment of ankle sprains can lead to chronic problems such as decreased range of motion, pain, and joint instability.

Controlled trials of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) in patients with ankle sprain showed that compared with placebo, NSAIDs were associated with improved pain control and function, decreased swelling, and more rapid return to activity. Diclofenac is meanwhile considered to be the gold standard in the treatment of joint sprains and other conditions. Topical diclofenac is well tolerated and is associated with fewer side-effects than other topical NSAIDs, mostly mild, easily resolved local skin irritation.

The current trial is designed to demonstrate the superior efficacy of Traumed® gel versus placebo and to assess the non-inferiority of Traumed® gel compared to diclofenac gel. After evaluation of entry criteria patients will be randomized to investigational treatment, which will be Traumed® gel or diclofenac gel or matching placebo gel, administered locally on the area of the injury, 3 times daily for 7 days. After end of the 7-day treatment phase patients will be followed up for another 7 days. Consequently the entire duration of the trial for each patient will be 14 days.

Patients will receive paracetamol (acetaminophen) 500 mg/tablets as rescue medication to be taken for pain relief when necessary.

All patients will receive soft support (elastic bandage). Grade 2 patients will receive a semi-rigid removable brace on Day 7.

Primary and secondary outcomes are listed separately as required. All statistical tests will be two-sided with a significance level of alpha =0.05, unless specified otherwise.

Confirmatory analyses

Area Under the Curve (AUC) for pain on passive movement in Visual Analog Scale (VAS) from Baseline to Day 4 (test for superiority, Traumed® gel versus placebo), Full Analysis Set (FAS).
AUC for pain on passive movement in VAS from Baseline to Day 4 (test for non-inferiority, Traumed® gel versus diclofenac gel), Per-Protocol (PP) analysis set.
If the first a priori ordered test (superiority) shows statistical significance, the subsequent hypothesis (non-inferiority) can then be tested individually in a confirmatory manner according to the principle of a priori ordered hypotheses.

Clinical safety will be addressed by assessing Adverse Events (AEs), physical examinations, vital signs and as needed laboratory assessments in a descriptive manner.

Estimation of sample size is based on the primary efficacy variable, AUC for pain on passive movement as measured by VAS from Baseline to Day 4. A two-sided test of equality of the investigational drug (Traumed® gel) and the comparator (placebo) at level 0.05 based on an expected raw scale treatment difference of AUC 25 [mm x days] and a common standard deviation of AUC 75 [mm x days] for the response variables (re-expressed for nonparametric evaluation in terms of the Mann-Whitney (MW) statistic as MW = 0.6, achieves a power of at least 90% for parametric first line analysis as well as for second line nonparametric analysis if the sample size is set to 291 patients for the Traumed® gel group and to 146 patients for the placebo group.

Due to an additional safety requirement that AEs with incidence level of 1% for Traumed® gel are found during the trial with probability 95%, 299 patients for the Traumed® gel group are required. Assuming a drop-out rate from the Safety Analysis Set of about 4% an amount of 312 randomized patients in the Traumed® gel group is needed. With an allocation ratio of 2:1:1 (Traumed® gel : diclofenac gel : placebo gel) 156 patients are obtained in the diclofenac gel and placebo group each, that is, a total of 624 patients with acute unilateral Grade 1 or Grade 2 sprain of the lateral ankle.

During the recruitment phase site inspections by the German Local Authorities in 2019 (Gesundheitsamt Düsseldorf of German Federal State North Rhine Westphalia, NRW) it was recognized that there could have been a possible violation of the predefined 'blinding firewall' described in the protocol at some locations.

All sites were checked rigorously to detect any risk of unintentional deblinding, which, in the end, was not found. To exclude any risk of including these patients, the German regulatory authority (Federal Institute for Drugs and Medical Devices) recommended including only those cases in the final analysis where blinding could be 100% confirmed.

In order to ensure the pre-defined power of the trial for the trial objectives including the confirmatory test for non-inferiority (Traumed® gel compared to diclofenac gel), which is based on the Per-Protocol Analysis Set (PP), a sample size enhancement is introduced for compensation of cases for whom maintenance of blinding procedures may have been compromised and, thus, are representing a major protocol violation (exclusion from PP analysis).

For compensation, the final sample size will be enhanced to 202 patients for the diclofenac and Placebo group each, and to 404 patients for the Traumed® gel group resulting in a new total of 808 patients .

Analyses will be based on the Safety Analysis, Full Analysis, and the Per-Protocol analysis sets. The definitions of the analysis sets follow those given in the ICH E9 guideline (CMP/ICH/363/96).
Click to expand...

NewsBot · Jan 17, 2024

Effects of Running Shoe Sole Hardness on Vibration and Neuromuscular Fatigue During a Half-marathon Run on a Treadmill (FAT-VIB)

During running, each contact between the foot and the ground causes an impact. Ground reaction forces (GRF) are considered as an input into the musculoskeletal system. It involves a sudden deceleration in the lower limb packages (including muscles) which generates Soft-Tissue Vibrations (STV). The body is able to attenuate Soft-Tissue Vibrations (STV) but this capability decreases with fatigue. STV could be minimize by improving shoe midsole hardness.
Detailed Description
Only 4 studies have studied Soft-Tissue Vibrations (STV) with a distance not exceeding 10 km and without evaluating the potential influence of the shoe. Thus, the effects of shoe midsole hardness on Soft-Tissue Vibrations (STV) and neuromuscular fatigue at the end of an intense and/or long run remains unknown.

The purpose is to compare two shoes whose only midsole hardness differs during a half-marathon on Soft-Tissue Vibrations (STV), neuromuscular fatigue and running kinetics.

Maybe the shoe ensuring a better STV damping of the medial gastrocnemius muscle would reduce neuromuscular fatigue and improve comfort.
Click to expand...

NewsBot · Jan 18, 2024

Optimization of Fractionation Schedules of Heel Spur Radiotherapy Prospective Randomized Open-label Trial

About 26 000 patients are treated per year with radiotherapy for non-malignant diseases in the Czech Republic, majority of them with heel spur syndrome which prevalence ranges from 8-10% in the general population. Heel spur represents important socioeconomic as well as health care issue. Radiotherapy by orthovoltage X-ray belongs to standard conservative treatment methods with proven antiinflammatory effect. Nevertheless, with increasing incidence of cancer, it may be assumed that availability of radiotherapy service for heel spur patients will be further limited including limitations related to potential pandemic or other emergency situation. This represents upcoming unmet clinical need, where alternative approaches with dramatically abbreviated fractionation schedules are needed in order to keep availability as well as effectivity of heel spur (and other non-malignant disorders) radiotherapy.

The aim to presented single institutional prospective randomized open-lable clinical trial is to evaluate low dose radiotherapy delivered in single fraction manner in the treatment of heel spur syndrome.

The project aims to design a randomized trial that compared fractionated and single fraction radiotherapy (non-inferiority). Patients will be randomized into 6 groups according to the total dose, total of 966 patients will be enrolled. The primary objective is to compare Calcaneodynia sum score at 3 months after radiotherapy between fractionated vs. single fraction radiotherapy.
Click to expand...

NewsBot · Jan 19, 2024

Biomarkers for Active Diabetic Foot Ulcers

This study is a platform study designed to efficiently test multiple biomarkers to identify diabetic foot ulcers (DFUs) with a higher potential for healing versus not healing that ultimately could be applied at the point of care to drive personalized management decisions, and to better inform clinical trials of wound healing interventions
Click to expand...

NewsBot · Jan 21, 2024

Does Radial Extracorporeal Shockwave Therapy Applied to the Achilles Tendon Influence Ankle Functionality?

Radial Extracorporeal Shockwave Therapy has been shown to restore shortened muscles and normalize fibrotic tissues in muscles or fascia. Shockwave therapy can soften fibrotic tissues and alleviate pain. While there are various methods to relax muscles and fascia, radial extracorporeal shockwave therapy can achieve good results in a short treatment time. Although there is research on the pain-related effects of radial extracorporeal shockwave therapy for conditions such as plantar fasciitis and knee osteoarthritis, there is a lack of literature on its functional effects. Therefore, this study aims to investigate the improvement of ankle functionality through the application of radial extracorporeal shockwave therapy.
Click to expand...

NewsBot · Jan 25, 2024

Extended Versus Limited Thoracoscopic Sympathectomy: Its Impact on Palmar and Plantar Hyperhidrosis

Conclusions: In the context of palmar and plantar hyperhidrosis, extended thoracoscopic sympathectomy seemed to be preferred over limited thoracoscopic sympathectomy due to better overall outcomes and minimal time for hospital stays and Compensatory hyperhidrosis.
Detailed Description
ABSTRACT Objective: The aim was to carefully evaluate and compare the results of extended sympathectomy versus T3, T4, and T5 resection in cases of palmer, axillary, and planter hyperhidrosis as regards decreased sweating and recurrence rates.

Methods: This was a randomized controlled prospective trial conducted at the Department of Vascular Surgery Mansoura University Hospitals on a total of 120 patients with hyperhidrosis who were divided into two groups; group 1 who had undergone limited sympathectomy and group 2 who had undergone extended sympathectomy.
Click to expand...

NewsBot · Jan 25, 2024

Mild Ankle Sprain Treatment: Functional Bandaging vs. no Immobilization (PED_HUIL0124)

Ankle sprains represent a prevalent pathology among the pediatric population that can result in residual effects when treated incorrectly. However, there is a lack of scientific studies defining the most appropriate therapeutic approach. The hypothesis is that patients treated solely with general measures, without external device support, experience a faster recovery compared to those treated with ankle immobilization. A clinical trial will be carried out by randomly assigning patients to either the functional bandaging group or the control group (general measures only). Prospective follow-up will be carried out by a online survey send by SMS, checking the functionality of the injured ankle using 'the Oxford Ankle Foot Questionnaire for Children (OxAFQ-C)', in addition to pain control and patient satisfaction with the treatment.
Click to expand...

NewsBot · Jan 31, 2024

The Effect of Foot Massage in Patients Undergoing Hemodialysis

Hemodialysis patients were divided into experimental and control groups. Foot massage was applied to the patients in the experimental group. Foot massage was not applied to the patients in the control group and routine nursing care was provided. Pre-test, mid-test and post-test sleep quality and fatigue level scores of the patients were determined.
Click to expand...

NewsBot · Feb 2, 2024

Efficacy & Safety of 980nm Diode Laser vs. Cryotherapy for Plantar Warts: RCT (LAVsCryWarts)

The goal of this clinical trial is to compare and test the efficacy of two treatments for plantar warts. The main questions it aims to answer are:

Which treatment has a higher cure rate for eliminating plantar warts? Which treatment causes less pain during the procedure?

Participants with plantar warts will:

Be randomly assigned to receive either cryotherapy or laser therapy Undergo 4 treatment sessions at weekly intervals Have their warts assessed for complete clearance after treatment Rate their pain levels during each session

Researchers will compare the cryotherapy and laser therapy groups to see if there are differences in:

Rates of complete wart clearance Pain levels reported during treatment Adverse effects
Click to expand...

NewsBot · Feb 3, 2024

Safety and Efficacy of Stem Cells for Diabetic Foot Ulcer

The objective of this clinical trial is to evaluate the effectiveness and safety of Wharton-Jelly mesenchymal stem cells administered around the ulcer site in patients with nonhealing diabetic foot ulcers. The key inquiries it seeks to address include the percentage of patients achieving complete healing/closure of the specified ulcer at any point during the 6-week period, the duration required for the complete closure of the target ulcer, and the nature and occurrence of adverse events (AEs), along with the total number of AEs and the proportion of patients experiencing AEs.

Patients meeting the eligibility criteria will receive either allogeneic mesenchymal stromal cells (MSC) or a placebo. The peri-ulcer injection of umbilical cord MSC or placebo will be administered at multiple locations, around the ulcer. Subsequent follow-up after the administration of umbilical cord MSC or placebo will be conducted to monitor and observe the progress of ulcer healing.
Click to expand...

NewsBot · Feb 3, 2024

Assessment of Vasomotion of People With Idiopathic Chilblains

Chilblains, also known as perniosis, is a non-freezing cold injury causing painful inflammatory skin lesions. Chilblains typically affect the dorsal feet or hands, causing inflammatory skin lesions that are often painful, and their pathogenesis remains only partly understood. To improve diagnosis and management, it is vital to focus entirely on chilblains and consider the patient-related and environmental factors that characterize this disorder. Because of this, it's critical to investigate the thermoregulatory function, of individuals with idiopathic chilblains while they are exposed to various environmental conditions (cold and neutral environments).
Click to expand...

NewsBot · Feb 4, 2024

Plantar Pressure Analysis and Foot Biomechanics in Lipedema and Chronic Venous Disease

Chronic venous disease (CVD) are common vascular pathology characterized by a wide spectrum of clinical manifestations occurring with symptoms and/or signs that vary in type and severity. The pathophysiological mechanisms of CVD start from the development of venous hypertension, leading to endothelial dysfunction and venous wall dilatation. Lipedema is subcutaneous adipose tissue disorder characterized by enlargement of both lower extremities. Previous studies showed that foot deformities such as pes planus or cavus are at a high prevalence in CVD patients, and the authors indicated that foot disorders are an important risk factor that negatively affects venous disease. To the best of our knowledge, there is only one study investigating plantar arch abnormalities in lipedema patients based on clinical observation. Therefore, the study aimed to investigate plantar foot distribution and foot deformity in patients with CVD and lipedema.
Click to expand...

NewsBot · Feb 7, 2024

A Study on Plantar Pressure Distribution, Gait Balance and Lower Back Pain in Pregnant Women

Brief Summary
The purpose of this study was to understand women with low arched feet, flat feet, or BMI> 29 in the third trimester.
Detailed Description
The purpose of this study was to understand women with low arched feet, flat feet, or BMI> 29 in the third trimester. Compare the intervention measures of different foot pads immediately, two weeks, four weeks, and six weeks after the intervention Immediate and long-term benefits in relief of plantar pressure, dynamic and static balance, and lower back pain.
Click to expand...

NewsBot · Feb 9, 2024

Effect of Graston Technique on Planter Thickness in Patients With Planter Fasciitis (PF)

Brief Summary
this study will be conducted to investigate the effect of Graston Technique on Planter Thickness in Patients With Planter Fasciitis
Detailed Description
Plantar fasciitis (PF), generally a self-limiting condition, is identified as one of the most common causes of heel pain in adults. It affects both sedentary and athletic populations .

It may be considered that PF emerges due to excessive and prolonged standing or running, which causes an acute inflammation or micro-tears, and degenerative changes plantar fascia. The persistence of these risk factors inhibits the regular repair process thus collagen degeneration occurs, causing the structural changes of the plantar fascia. Numerous interventions have been described for treatment of PF, which include: Stretching calf or plantar region which is performed with the patient stands with staggered legs facing toward a wall, with both hands stretched out .The Graston technique can break up scar tissue and restore soft tissue. The Graston technique is a type of manual therapy in which patented stainless-steel instruments are used to restore soft tissue motion by breaking up scar tissue. fifty patients with planter fasciitis will be assigned randomly to two equal groups; first one will receive graston technique in addition to exercise program, the second one will receive exercise program only for six weeks
Click to expand...

NewsBot · Feb 10, 2024

A Multi-centre Study of Shoe-worn Insoles and Knee Osteoarthritis (MULTIWEDGE)

Shoe-worn insoles (also known as orthotics) can provide symptomatic relief for people with knee osteoarthritis. However, given they act at the feet, and given that many people with knee osteoarthritis also report foot pain, it is important to assess the effects of these devices at both joints. We will conduct a multi-centre randomized pilot trial to determine feasibility and preliminary efficacy.
Click to expand...

NewsBot · Feb 12, 2024

Primary Subtalar Arthrodesis for Calcaneal Fractures

Management of severe injuries to the heel (displaced intra-articular calcaneus fractures) continues to be a major challenge for orthopedic surgeons. Previous studies have demonstrated poor outcomes, and results show that patients experience long-term pain and decreased quality of life postoperatively. Poor outcomes are driven by pain, in particular, which is linked to post-traumatic subtalar arthritis.
Click to expand...

NewsBot · Feb 14, 2024

Improvement of Diabetic Foot Care in Salamanca Through the Implementation of Standardized Protocols.

Introduction: Diabetic foot (DF) is among the most prevalent complications affecting individuals with diabetes. In Salamanca, 25,631 individuals are enrolled in the Diabetes Care Service, with only 3.06% undergoing a foot examination.

Objective: To evaluate the effectiveness of implementing a standardized foot care protocol for individuals with diabetes, accompanied by a sensitization and training strategy for nursing professionals.

Methodology: Quasi-experimental pre- and post-study with a control group conducted in the Health Centers of Salamanca.

Population: Patients included in the Diabetes Care Service (306) (12,458 men and 11,348 women).

Measurements:

In professionals: number of professionals involved and satisfaction level. In diabetic individuals: Sociodemographic, anthropometric, lifestyle, and clinical variables related to disease control will be measured, along with variables related to protocol implementation (percentage of diabetics who have undergone foot examination, Ankle-Brachial Index (ABI), risk stratification and foot monitoring, percentage of individuals with DF, percentage of individuals with healed DF ulcers, and percentage of individuals who have undergone amputation). Improvement in quality of life will be measured using the COOP-WONCA questionnaire.

Expected outcomes: It is anticipated that this study will provide evidence regarding the relationship between protocol implementation and an increase in the detection and care of at-risk feet and DF, as well as an improvement in the quality of life of individuals with diabetes.
Click to expand...

NewsBot · Feb 16, 2024

Effect of BFR Rehab After Achilles Tendon Rupture

The purpose of this study is to determine if blood flow restriction therapy after Achilles tendon rupture reconstruction decreases post-operative calf atrophy, improves reported outcomes, and ultimately decreases return to play time.
Click to expand...

NewsBot · Feb 21, 2024

Early Post-operative Monitoring by Sensor of Patients Undergoing Forefoot Surgery

The goal of this clinical trial is to evaluate the monitoring using a sensor in patients who have undergone forefoot surgery, during the first 7 post-operative days.

The monitoring tool has a Global Positioning System (GPS) beacon, a 3-axis accelerometer and a temperature sensor, as well as an "emergency call" button.

The main objective it aims to answer are:

to evaluate the feasibility of post-operative monitoring using this tool
to evaluate the reliability of the tool
The investigators hope to determine if using this tool can be able to provide patients a "connected" personalized real-time monitoring for follow-up.
Click to expand...

Clinical Trials Updates

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

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

Useful Searches