Clinical Trials Updates

NewsBot · Sep 26, 2014

A Prospective, Randomized, Controlled, Multi-Center, Study Evaluating AutoloGel Therapy for Complete Closure of Wagner Grade 1-4 Diabetic Foot Ulcers, Venous Leg Ulcers and Stage II-IV Pressure Ulcers

This study is designed to demonstrate the outcome of complete ulcer closure of patients with Wagner Grade 1-4 DFUs, VLUs or Stage II-IV PUs using AutoloGel versus Usual and Customary Care (UCC).
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NewsBot · Sep 26, 2014

Foot Orthoses in Patellofemoral Pain Syndrome: a Prospective Randomized Study of Morpho-specific Versus Placebo Orthoses

Patellofemoral pain syndrome is one of the most common musculoskeletal disorders. It is defined as an anterior knee pain. Its origin is a conflict during patellar tracking, due to patellofemoral malalignment and soft tissue overload.

A few recent studies seem to show a benefit of prefabricated feet orthoses in patellofemoral pain syndrome, alone or in association with rehabilitation. However, no one has analyzed the outcome of morpho-specific foot orthoses in a prospective randomized study.

The purpose of this prospective randomized study is to compare clinical outcomes in daily living and in sports activities, between morpho-specific and placebo foot orthoses.

Morpho-specific foot orthoses are designed according to the patient's morphotype. They are intended to correct structural defects of the hindfoot, midfoot and forefoot, in the aim to correct abnormal overload during patellofemoral tracking.
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Experimental: Morpho-specific foot orthoses
Morpho-specific thermo-molded foot orthoses are designed according to the patient's morphotype.
Orthoses are custom-molded from different materials such as BIOFLUX resin, Covercuir MF, EVA300/60, EVA400/70, PE255/55, ABSORB Dur and CAPITON PU.

Device: Foot orthoses
Placebo Comparator: Placebo foot orthoses
The placebo foot orthoses will be made with the same principle of molding and with the same materials as for the experimental group. The only difference is that they involve no active corrective insert element : they will be made without morphotype correction.
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NewsBot · Sep 29, 2014

Shockwave Therapy of Chronic Diabetic Foot Ulcers

Introduction:
Foot ulcers are a feared complication among diabetic patients. The ulcers can cause pain, discomfort and reduced quality of life. The development of foot ulcers places the patients at a risk of amputation. In the Danish Health Care System a substantial effort is done to prevent and treat diabetic foot ulcers. A constant research of how to treat these wounds is ongoing. The goal is to optimize wound healing and prevent amputations.

Extracorporeal shockwave therapy (ESWT) involves the use of a device that generates low-energy shockwaves through a headpiece, which is placed on the skin of the patient. A small amount of energy will be deposited in the tissue when shockwaves are applied. This stimulates the cells to produce substances that generate new vessels. No side effects to ESWT have been shown.

Purpose:
The investigators want to test whether shockwave therapy can improve wound healing among diabetic patients with foot ulcers.

Hypothesis:
The investigators hypothesize that shockwave therapy accelerates ulcer healing, increases blood flow, reduces pain, and has no side effects.

Method:
Patients who are interested in participation will be included in the study and divided by randomization into two groups of equal size. The first group is treated with ESWT in combination with regular guideline treatment. The second group is set up as control group and will only receive regular guideline treatment. The participants are examined in different ways to evaluate whether ESWT helps the healing of foot ulcers. The investigators want to measure toe blood pressure, tissue oxygen pressure and foot sense of touch. The foot ulcers are tested for infection before, during and after the treatment. The size of the ulcers are measured and photographed each time. The investigators will count how many foot ulcers that are completely healed during the test period and measure the sizes of the remaining foot ulcers. The patients are asked to evaluate pain related to the foot ulcer. Data concerning participants' co morbidities and use of analgesic drugs are obtained from the patient journal and by patient interview.

Significance:
ESWT should be considered a supplement to existing clinical guidelines in wound management if shown to effectively help healing of diabetic foot ulcers. Improved healing should reduce the heavy workload on care and treatment regarding to these wounds. Hopefully, the frequency of amputations among diabetic patients will decline by implementing new treatment options for the diabetic foot.
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NewsBot · Sep 30, 2014

Effects of Manual Therapy and Exercise in the Treatment of Ankle Sprains

Objectives: To analyze the effects of proprioceptive and strengthening exercises versus the same exercises and manual therapy on the recurrent ankle sprain management.

Design: A randomized clinical trial with two intervention groups and triple blind.

Settings: University Hospital.

Participants: Fifty-four patients with previous history of recurrent ankle sprains, regular sports practice and pain during the physical activity, randomly assigned to experimental or control group.

Intervention: Control group performed 4 weeks of proprioceptive and strengthening exercises; experimental group performed 4 weeks of the same exercises combined with manual therapy.

Main Outcomes Measures: Pain, ankle instability, pressure pain threshold (PPT), ankle eversion strength, and active range of motion in ankle joint. The measures were taken before, after and one month after the interventions.
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NewsBot · Oct 3, 2014

The Influence of High Heeled Shoes on the Sagittal Balance of the Spine and Whole Body

The purpose of this study is to investigate the influence of high heeled shoes on the sagittal balance of the spine and the whole body.

The investigators hypothesize that wearing high heeled shoes leads to a hyperlordosis of the cervical spine, a decrease of thoracic kyphosis, hyperlordosis of the lumbar spine and a posterior tilt of the pelvis resulting in a posterior shift of the body's center of gravity. This would be an explanation for the increased prevalence of back pain in individuals frequently wearing high heels.

In order to assess these changes, differences in the two following outcome parameters will be measured on a standing lateral EOS-radiograph of the whole body - barefoot and with high heeled shoes: spino-sacral angle (primary) and meatus plumb line (secondary) .
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NewsBot · Oct 6, 2014

Prospective Evaluation of Treatment for Clubfoot

Purpose
All patients who meet inclusion criteria and who agree to participate in the study will be evaluated for classification of clubfoot reducibility (Dimeglio 1995), which characterizes the four components of clubfoot deformity including equinus, heel varus, calcaneopedal rotation, and forefoot adduction.

Patients will be allowed to select treatment with either the daily massage and taping technique or the Ponseti casting technique. It is not practical or feasible to randomize patients as transportation and scheduling, as well as family preference and willingness to participate, are primary factors in the French physical therapy method of massage/taping.

Once treatment intervention has been determined, patients will be enrolled into the surgical or one of two non surgical arms (French physical therapy or Ponseti casting) of the study. Research participation entails the retrospective and prospective review of data collected through standard medical care.

All patients who undergo clubfoot treatment, may have the following evaluations:

Standard-of-care

Clinical exams- will be conducted at the initial visit, 4 weeks, 8 weeks, 12 to 14 weeks, 6 months, and 9 months following treatment. Also at 1 year, 18 months, 2 years, 3 years, 4 years, 5 years, and 10 years of age and at skeletal maturity.
Radiographs- standing AP and laterals of both feet may be taken at 18 months, 4 years of age, and at skeletal maturity (for a total of 12 possible radiographs over the span of the study).
Investigational

Questionnaires - at age 4, age 10, and at skeletal maturity: patient/parent baseline assessment.
Radiographs- standing AP and laterals of both feet (for a total of 4 radiographs) will be taken for all adult participants.
Movement Science Lab- at 2, 5, 10 years of age and at skeletal maturity. This testing may include walking with reflective markers and electrodes attached with tape to his/her legs, walking across a pressure plate, video, digital pictures, wearing a step monitor, strength testing, and an agility test.
Physical therapy - at 4 years of age: developmental motor scale; at 10 years of age and at skeletal maturity: motor proficiency assessment.
Brace compliance - patients will have a temperature logger placed in the shoes of the Dennis-Browne Bar at the initial fitting visit in the Orthotics department. At every subsequent clinic follow-up visit the Orthotist downloads the time/temperature data onto a laptop from the sensor reader (A piece of computer hardware which the sensor clips into and is attached to the laptop via the USB port). The Orthotist will then reset the temperature logger discs in order to monitor the next period of brace wear.
The following additional evaluations may be conducted on the patients who also have surgical treatment of clubfoot:

Standard-of-care • Clinical exams and radiographs will be conducted as is required by the surgeon. No additional radiographs are needed for investigational purposes.

Investigational

• Movement Science Lab testing may be done before surgery, 1, 2,5, and 10 years following surgery, and at skeletal maturity.

In addition, relevant retrospective data from your child's medical chart including clinical history, radiographs, and data collected in the Movement Science lab, may be used.
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NewsBot · Oct 8, 2014

Manuka Honey for Wound Care

Since antiquity, honey has been recognized for its healing properties. Literature about the use of medicinal honey for wound care dates back centuries with recent data suggesting its use in patients suffering from burns or pressure ulcers. Research has shown Manuka honey (Leptospermum scoparium) to have significant immune benefits and the ability to influence all phases of wound healing: inflammation, proliferation and remodeling. In addition, numerous clinical studies have identified positive benefits for wound healing. However, there is a lack of prospective, randomized controlled data on the use of honey as a medicinal agent in local wound care and scar healing.

In order to better understand Manuka Honey's ability to aid in healing, the investigators are conducting a randomized, controlled, single-blinded study of patients undergoing reconstructive surgery. This project uses split thickness skin graft and free tissue transfer donor sites as standard wound models to compare the effects of Manuka Honey versus standard wound care therapies. Through the use of standard wound model and objective measurement tools, the investigators hope to better elucidate any benefits of this novel wound care 'technology.'
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NewsBot · Oct 11, 2014

GrafixCORE®: Open-Label Study to Evaluate the Safety and Efficacy of GrafixCORE® for Complex Diabetic Foot Wounds

A multicenter, open-label, single-arm study to evaluate the safety and efficacy of GrafixCORE® for the treatment of complex diabetic foot wounds with exposed tendon and/or bone.
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NewsBot · Oct 17, 2014

Efficacy and Safety of Intramuscular PDA-002 in Subjects Who Have Diabetic Foot Ulcer With Peripheral Arterial Disease

The PDA-002-DFU-002 trial is a Phase 2, multicenter, randomized, double blind, placebo controlled, dose range finding study. The study will enroll approximately 133 subjects in four treatment groups. The primary objective of the study is to assess the efficacy and safety of PDA-002 administered intramuscular (IM) in subjects who have DFU with PAD. The secondary objective is to explore potential clinical efficacy by assessing changes in vascular parameters such as Ankle-Brachial Index and Toe-Brachial Index (ABI and/or TBI), Transcutaneous oxygen measurements (TcPO2) and pulse volume measurements.
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NewsBot · Oct 18, 2014

A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Onychomycosis of the Toenail

VT-1161 is a novel, oral inhibitor of fungal lanosterol demethylase (CYP51). In vitro and in vivo pharmacology studies have demonstrated that VT-1161 is highly active against dermatophytes that cause onychomycosis . VT-1161 is highly selective for fungal CYP51, and data suggests that it may avoid the side-effect profile that limits the use of commonly prescribed antifungal agents for the treatment of onychomycosis.
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NewsBot · Nov 1, 2014

Community Walking Enhanced by Orthoses for Patients With Peripheral Artery Disease

The primary aim of this study is to investigate the effect of an ankle foot orthoses (AFO) on the primary outcome of peak walking time (PWT) in patients with peripheral artery disease (PAD).
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NewsBot · Nov 5, 2014

Ultrasound Guided Single Shot Block of Posterior Tibial Nerve for Postoperative Pain Relief After Hallux Valgus Surgery

Hallux surgery is known to be extremely painful. Standard pain therapy is treatment with NSAID and opioid painkillers. Patients are frequently not-satisfied with this. Some institutions use a nerve block (single shot or catheter technic) of the ischiadic nerve. But this procedure is invasive, has a potential risk of nerve lesion, and is not accepted by all surgeons. A single shot nerve block of the posterior tibial nerve is less invasive and could be superior compared to standard pain treatment. A great variability of nerve supply of the foot is well described. There are some hints that the posterior tibial nerve supplies the first metatarsal bone and the first metatarsal joint. A nerve block could reduce postoperative pain in hallux surgery. To assess the effectiveness of this investigated measure, the requested morphine dose of a PCA pump will be used to verify the effectiveness of the tibial nerve block.
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NewsBot · Nov 18, 2014

Talar Avascular Necrosis: Surgical Angiogenesis vs. Core Decompression (TalarAVN)

The purpose of this study is to determine if surgical angiogenesis performed in talar avascular necrosis by free microvascular bone grafts from the femoral condyle is a superior technique compared to core decompression and nonvascularized osseous autografts.
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NewsBot · Nov 19, 2014

Larval Debridement Therapy Versus Sharp Debridement to Remove Biofilm From Chronic Diabetic Foot Ulcers

This is a prospective study of Veterans with diabetic foot ulcers who will be randomized to either a Larval Debridement Therapy group (Biobags every 4 days x 2 applications) or a Sharp Debridement Therapy group (standard or control weekly x 2) during an 8 day study period.
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NewsBot · Nov 20, 2014

Evaluation of Treatment Factors in the Management of Chronic Iliotibial Band Syndrome in Female Distance Runners

The primary objective of this study is to determine if a more specific exercise routine that incorporates a progressive hip stability program will help to rehabilitate the hip and reduce symptoms of iliotibial band syndrome more than conventional hip exercises. Three different exercises interventions will be compared to determine its effectiveness in reducing pain, improving function and returning subjects to running symptom free. Secondary objective for this study is to establish an intervention program for female runners with this injury. There will be three treatment arms and participants will be randomly assigned to one of three groups: Group A- control (stretching), group B (conventional hip exercises and group C (experimental treatment- specific progressive hip exercises).
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NewsBot · Nov 28, 2014

PATH-2: Platelet Rich Plasma in Achilles Tendon Healing

Does using a Platelet Rich Plasma (PRP) injection immediately before standard casting benefit patients between the ages 18-70 years who are suitable for nonsurgical treatment of the Achilles tendon rupture (ATR). This is a multicentre, blinded, randomised, placebo controlled trial with two sub studies: (1) blood sample analysis and (2) needle biopsy in 16 participants.

ATR is the most common tendon injury and lead to months of incapacity. With an average work absence of 63108 days there are significant societal and National Health Service (NHS) costs. PRP potential benefit is to improve recovery and return to normal activities earlier, and reduce the NHS and societal impact. The investigators will investigate the efficacy of PRP using disease specific and patient important outcomes to improve the evidence for this treatment of ATR.

A minimum of 15 United Kingdom (UK) NHS hospitals will be included to recruit 214 participants. Patients will be identified in the orthopaedic outpatient clinic, usually following an emergency hospital attendance for ATR. After checking eligibility and the informed consent process, baseline data is collected and participants randomised to either 'PRP injection' or 'Imitation (placebo) injection'. Participants' own blood sample is taken and prepared according to allocation. The injection is delivered by a trained surgeon in clinic who will be aware of allocation, the participant remains blind.

Participants complete a pain diary and have four study assessments at 4,7,13 and 24 weeks, carried out by a member of the research team blind to allocation. Assessments take place over the telephone or during a hospital outpatient visit. The 24 week hospital visit includes an exercise test of ankle function. All assessments include collection of patient reported responses to pre-set questions.

The results may be applicable to the many other tendon and ligaments injuries. The National Institute for Health Research (NIHR)/Medical Research Council (MRC) Efficacy and Mechanism Evaluation Programme provide funding and University of Oxford is Sponsor.
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NewsBot · Dec 1, 2014

Morton's Neuroma: Manipulation Versus Steroid Injection

The aim of this study is to establish which of two treatment options is the preferred intervention in the treatment of Morton's Neuroma.

A randomised controlled trial shall be performed. Steroid injection is the current gold standard conservative treatment for this condition. Therefore, manipulation shall be compared to a control group receiving a steroid injection in an equality randomised controlled trial.

Outcomes will be compared using visual analogue pain scales (VAS), The Manchester-Oxford Foot Questionnaire (MOXFQ), The Foot and Ankle Ability Measure (FAAM), the SF-36 quality of life questionnaire and algometric pressure threshold testing. An improvement in either groups' VAS of 20mm above the other group shall be considered as the minimum worthwhile change as this has been identified as the minimum clinically important difference in pain between treatment groups in visual analogue pain scales.

There is limited research evidence to support the management of Morton's neuroma with steroid injection although its efficacy has only been demonstrated in the short term.
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NewsBot · Dec 4, 2014

Effects of Foot Strengthening on the Prevalence of Injuries in Long Distance Runners

The hypothesis is that a strengthening program for foot and ankle muscles can alter the prevalence of lower limbs injuries on long distance runners, lowering the harmful forces that these segments receive. The participants will be randomly assigned into control group (without intervention) or into intervention group, that will receive an 8 weeks strengthening intervention, twice a week, for 30 minutes each session. This will aim for increasing foot and ankle range of movement and muscle strength.
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NewsBot · Dec 4, 2014

Effectiveness of Autologous Platelet Rich Plasma in the Treatment of Chronic Non-Healing Wounds

This investigation plans to initiate the healing of chronic wounds by providing a concentrated platelet and growth factor therapy directly to the wound site by topical delivery. This therapy will be derived from autologous platelet rich plasma (PRP), an emerging surgical and wound care treatment. This investigation aims to demonstrate that patients with chronic, non-healing wounds treated with autologous PRP and standard medical care have a reduction in wound volume and improved healing rate that results in patient-centered clinically significant health outcomes as compared to patients treated with standard medical care only.
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NewsBot · Dec 4, 2014

Rehabilitation Programs After Achilles Tendon Rupture

The purpose of this study is to evaluate the effects of early mobilization versus traditional immobilization rehabilitation programs after surgical Achilles tendon repair on the mechanical (torque-angle and torque-velocity relationships) and electrical (neuromuscular activation) properties of the plantar- and dorsiflexor muscles, gastrocnemius medialis morphology (muscle architecture), functional performance, and the mechanical and material properties (force-elongation and stress-strain relationships) of the injured and uninjured Achilles tendon.

The hypothesis is that the early mobilization could reduce the deleterious effects of the joint immobilization and improve the tendon healing.
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NewsBot · Dec 10, 2014

A Prospective, Randomized Clinical Trial of ECLIPSE PRP™ Wound Biomatrix in Non-Healing Diabetic Foot Ulcers

A prospective, randomized, controlled, clinical study to establish clinical based evidence of Eclipse PRP™ and compare its performance with the usual and customary practice for the treatment of Wagner 1 or 2 DFUs.
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NewsBot · Dec 10, 2014

Topical Oxygen Therapy for Diabetic Foot Ulcers (TOFU)

This study is to observe the effect of application of topically administered oxygen on healing rate, cost of care and rate of amputations in diabetic patients with foot ulcer(s) (DFU). The proposed study is a pragmatic (comparative effectiveness research, CER) study, in which the effectiveness of topical oxygen (100%) administered 4 days per week, for 16 weeks, for the treatment of diabetic foot ulcer (DFU) will be measure and compared with standard of care (SoC) treatment. There will be a 2 patient groups (including a comparison groups and a treatment groups) including: (1) Medicaid patients who are at Wagner grade 2 and below, will only receive standard treatment (2) Medicaid patients who are at Wagner grade 2 and below, will receive standard treatment plus Topical Oxygen Therapy. All of the Topical Oxygen Therapy will be provided in a home care setting or extended care facility.100 patients will be recruited.

This study is to assist the Ohio Department of Medicaid (ODM) and to provide efficient and effective administration of the Medicaid program.

This is an observational and descriptive study that will seek to generate a hypothesis. Due to the small sample size this study will primarily be a feasibility study that will attempt to measure and evaluate differences in the relative costs of the intervention of topical oxygen therapy on this population and subsequently compare outcomes in areas such as overall health improvements and cost effectiveness. The patient population will consist of Medicaid beneficiaries with DFU at Wagner grades 2 and below who are enrolled in the United Health Care Community Plan of Ohio (UHC).
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NewsBot · Dec 15, 2014

Genetic Contribution to the Pathophysiology of the Charcot Foot in Qatari Patients With Diabetes

To assess the hypothesis that Charcot foot is associated with more vascular complications compared to matched diabetic patients without Charcot foot and to classify patients with Charcot foot according to the human genetic classification of the Qatari population.
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NewsBot · Dec 19, 2014

Diabetic Foot Ulcer Prevention System (DFUPS)

To evaluate a recently developed non-invasive infrared thermal camera called Diabetic Foot Ulcer Prevention System (DFUPS) in a clinical setting by studying healthy volunteers.
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NewsBot · Dec 19, 2014

Early Mobilization After Achilles Tendon Rupture (EarlyM-Achil)

The purpose of this study is to determine whether early mobilization after Achilles tendon rupture can speed up healing and improve patient outcome.
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NewsBot · Dec 19, 2014

A Study of the Impact of Head Position on Foot Pressure in Stance

When examining a subject in quiet stance from the side, the leg segment is usually seen to be oriented upwards and forwards by about 5°; the knee may be flexed by a few degrees, the shoulders are behind the great trochanter and the head is held forwards. The forward head position moves the center of gravity forwards and thus may increase pressure under the forefoot. Conversely, moving the head backwards should be accompanied by an increase in pressure under the heel and thus decreased pressure under the forefoot.

The study's objective is to study the influence of alignment of the head with the back (i.e. a rearward head position) and head rotation on the foot pressure distribution (measured using a foot pressure platform).
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NewsBot · Dec 23, 2014

Antifungal Activity of Loceryl Nail Lacquer in Combination With a Cosmetic Varnish (COOL)

The main objective is to compare efficacy, in terms of antifungal activity of Loceryl Nail Lacquer associated with a Cosmetic Varnish and Loceryl Nail Lacquer alone, in the treatment of mild to moderate toenail Distal Subungual Onychomycosis.

The second objective of this study will be photographic follow-up of clinical improvement and cure after the initial treatment period of 12 weeks, for 15 additional months.
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NewsBot · Dec 23, 2014

International Pachyonychia Congenita Research Registry (IPCRR)

International Pachyonychia Congenita Research Registry (IPCRR) is a patient registry for those suffering from Pachyonychia Congenita (PC). PC is an ultra-rare extremely painful skin disorder that causes painful blisters and callus on feet and sometimes hands, thickened nails, cysts and other features. The IPCRR consists of a questionnaire, patient photos, physician notes from telephone consultation to validate questionnaire, free genetic testing.
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NewsBot · Dec 31, 2014

Development of a Cellular Biomarker for the Diagnosis and Treatment of Diabetic Foot Ulcers

This project aims to result in the identification of such markers, and the development of a feasible quantitative method of distinguishing between tissue that has the capacity to heal and tissue that does not, thus identifying a non-healing phenotype.
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NewsBot · Jan 2, 2015

Validation of the Foot and Ankle Ability Measure Tool in Finnish (FAAM-Fi)

The purpose of this study is to validate the Foot and Ankle Ability Measure in Finnish.
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NewsBot · Jan 6, 2015

Allogenic Dermis Versus Standard Care in the Management of Diabetic Foot Ulcers

This is comparison trial comparing human dermis to standard wound care for non healing diabetic wound
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NewsBot · Feb 2, 2015

Effectiveness of Aurix Therapy in Diabetic Foot Ulcers

The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, randomized trial in which diabetic food ulcers (DFU) will be treated using Aurix plus Usual and Customary Care (UCC) and compared to a group receiving just UCC as provided in up to 100 U.S. wound centers
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NewsBot · Feb 6, 2015

Preventing Amputations by Tailored Risk-based Intervention to Optimize Therapy (PATRIOT)

The PATRIOT study will evaluate a risk-based personalized behavioral intervention to improve foot self-care, self-monitoring, and modifiable risks for amputation such as blood glucose, blood pressure and cholesterol in order to prevent diabetic foot ulcers in patients at higher than normal risk for amputation. This novel intervention aims to improve self-care and early detection of foot abnormalities in at-risk patients with diabetes and poor foot self-care using advanced behavioral approaches to target adherence to multiple health behaviors, including foot self-care, self-monitoring, medication adherence, dietary adherence, and physical activity simultaneously. If this promising behavioral theory-driven approach delivered using common technology (phone) to the patient at home can work in a setting where improvements in foot care are so urgent, it will be an important scientific contribution.
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NewsBot · Feb 6, 2015

Secondary Prevention of Foot Ulcers (STEP UP)

This study will evaluate a comprehensive tailored behavioral intervention aimed to improve foot self-care and self-monitoring (combined with dermal thermometry) to prevent recurrent ulcers in Veterans at highest risk of amputation. This intervention may be a novel strategy for improving self-care and early detection of foot abnormalities in this at-risk population using psychological theories to target multiple health behaviors simultaneously. This could be an efficient and cost-effective approach to improve diabetes-related foot health behavior, and other risk factors in patients who are vulnerable to devastating consequences related to amputation.
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NewsBot · Feb 6, 2015

APT001 Plasma/NO Generator to Treat Infected Diabetic Foot Ulcer in Adults (APT-14-002)

This is a 10-week, randomized, controlled study to evaluate the efficacy and safety of the APT001 plasma and nitric oxide treatment in subjects with a diabetic foot ulcer.
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NewsBot · Feb 28, 2015

Implementation of Foot Thermometry and SMS to Prevent Diabetic Foot Ulcer

Purpose
This protocol aims to implement daily temperature measurements of feet and SMS to prevent diabetic foot ulcer in patients with diabetes mellitus type 2 and high risk patient.

Design: Physician-blinded, randomized, 12-month trial.

Setting: Recruitment will be performed in Diabetes Outpatient Clinics at two Ministry Health tertiary hospitals: Cayetano Heredia Hospital and Arzobispo Loayza Hospital.

Population: Subjects will be eligible if they have a diagnosis of diabetes mellitus type 2, are between 18 - 80 years of age, have a present dorsalis pedis pulse in both feet, are in risk group 2 or 3 using the diabetic foot risk classification system as specified by the International Working Group on the Diabetic Foot, have an operating cell phone or a caregiver with an operating cell phone, and have the ability to provide informed consent.

The investigators hypothesize that through the synergies created by implementing an enhanced intervention that combines the proven method of temperature measurement for the reduction of diabetic foot ulcer with the proven method using SMS reminders, the investigators will leapfrog these conventional interventions to improve patient measurement compliance and reduce diabetic foot ulcer in low middle income country.
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NewsBot · Mar 4, 2015

Wound Healing Process in Diabetic Neuropathy and Diabetic Neuroischemia (Geko)

Diabetes mellitus is one of the leading causes of illness worldwide. Diabetes can affect nerves, skin and blood vessels. Diabetics with problems in their nerves can lose the sense of touch in their feet (called neuropathy) and so may unknowingly cause damage to the skin resulting in skin loss or an 'ulcer'. Diabetics also have difficulty healing any damaged tissues especially if they have diseased blood vessels causing a lack of blood to areas of the body including the feet (called ischaemia).
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Primary Outcome Measures:
Improvement in ulcer size at monthly intervals up to 12 months follow up. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
The wound will be measured after the electrical stimulation produced by Geko device is applied.

Secondary Outcome Measures:
Proportion of wounds healed at monthly intervals up to 12 months followup [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Percentage of wounds healed after the electrical stimulation produced by Geko device is applied.
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Diabetes mellitus is one of the leading causes of illness worldwide. Diabetes can affect nerves, skin and blood vessels. Diabetics with problems in their nerves can lose the sense of touch in their feet (called neuropathy) and so may unknowingly cause damage to the skin resulting in skin loss or an 'ulcer'. Diabetics also have difficulty healing any damaged tissues especially if they have diseased blood vessels causing a lack of blood to areas of the body including the feet (called ischaemia). Therefore diabetics have a greater chance of having an ulcer and a higher chance that it does not heal up. The loss of a protective skin barrier means that bacteria can enter the foot causing infections which can spread to bone and beyond. Ultimately this can result in gangrene, amputation or even death.

Stem or progenitor cells help repair and replace damage in the body. Blood vessels are key to this repair. Recent research has suggested that special progenitor cells found in the blood may be responsible. They are called Endothelial Progenitor Cells (EPCs) and seem to be in fewer numbers and are less effective at repair in diabetics.

Current treatments for diabetic wounds are not always successful and so we need more research to look at new treatments. One possibility is to use electrical stimulation of nerves in the leg. Research studies have shown this may improve blood circulation and healing of wounds. This research will assess EPCs to see if they are linked to ulcer healing in diabetic patients with neuropathy only or with ischaemia as well. Furthermore we wish to investigate whether electrical stimulation can affect progenitor cells and wound healing in these patients. The longterm goal of this research is to help diabetic patients improve their quality of life by reducing woundrelated complications
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NewsBot · Mar 4, 2015

Evaluation of the Antibiofilmogramme® Test During Diabetic Foot Infections (BioFilm PieDia)

The primary objective of this study is to investigate the role of antibiogramme-antibiofilmogramme concordance (in terms of S. aureus strains and prescribed antibiotics) in the presence/absence of S. aureus strains at the end of a first regimen of antibiotics.
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NewsBot · Mar 12, 2015

RESTIFFIC™ Foot Wrap Reduces Moderate to Severe Restless Leg Syndrome

The purpose of this study is to determine the safety and efficacy of RESTIFFIC™, a foot wrap that produces adjustable targeted pressure on specific muscles in the feet, to reduce the symptoms of moderate to severe primary Restless Legs Syndrome.
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NewsBot · Mar 12, 2015

Hallux Valgus and Custom Orthotic Prescription

Hallux valgus can be defined as a progressive subluxation of the first metatarsophalangeal joint and lateral deviation of the hallux. This common foot condition is associated with altered gait patterns. Specifically reduced forward propulsion, leading to gait instability. Research has shown that foot problems and pain play a major role towards the contribution of falls in the adult population. There are currently two main interventions for the treatment of hallux valgus: surgery and orthotic prescription. There has not been a lot of research performed evaluating the effects of custom orthotic prescription on hallux valgus.

Therefore, this study will investigate adults with moderate hallux valgus and the effects of orthotic intervention on the efficacy of forward propulsion during walking. It is hypothesized that implementation of an orthotic will lead to decreased foot pain, an increase in step length, an increase in the forward moment about the ankle and hallux, and a more medial center of pressure tracking through the great toe instead of the lesser metatarsals.

This study will consist of 10 adults. The participant will go through three rounds of testing in the lab. The first session will consist of initial baseline testing in which each participant will be evaluated for severity of Hallux Valgus and range of motion of the first metatarsophalangeal joint. A foot casting will then be performed by a pedorthist and the participant will be set up with markers, so as to record motion while they perform 15 walking trials across a 10m runway with a force plate embedded in the middle whilst wearing standard footwear (no orthotic). The second lab session will consist of the standard footwear (no orthotic) walking as well as the addition of standard footwear with custom orthotic walking. The third session, after having worn the orthotic for two weeks, will repeat both conditions measured in the second lab session. Data about the center of pressure trajectories, step length, foot pain, and the moments about the ankle and first metatarsophalangeal joints will be collected and calculated.
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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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