Clinical Trials Updates

NewsBot · Apr 4, 2013

A Comparison of the dermaPACE® (Pulsed Acoustic Cellular Expression) Device in Conjunction With Standard of Care Versus Standard of Care Alone in the Treatment of Diabetic Foot Ulcers

The Sponsor of this study, SANUWAVE, Inc., has developed an investigational device known as the dermaPACE® (Pulsed Acoustic Cellular Expression) device for the possible treatment of diabetic foot ulcers. This device generates acoustic (sound) pressure waves designed to act on the cells in your body to generate proteins that may lead to wound closure. The dermaPACE® device has not been approved for the treatment of diabetic foot ulcers; therefore its use in this study is investigational.

The purpose of the study is to evaluate the ability of the dermaPACE® device to help diabetic foot ulcers heal more quickly. The active study device, the dermaPACE®, will be compared to an inactive look-alike device (called a "Sham") in this study. The sham device will not provide any treatment to your diabetic foot ulcer.
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NewsBot · Apr 26, 2013

Open-Label Study in Diabetic Foot Ulcers (DFU), to Evaluate Safety of 0.03% DSC127 Topical Gel in Chronic Use (STRIDE 5)

This open-label study is designed to assess the chronic-use safety of 0.03% DSC127 gel administered on a once daily basis for up to 12 weeks per treatment period, potentially over multiple treatment periods with 4-week wash-out periods between treatment periods.
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NewsBot · Apr 26, 2013

The CurePPaC Study - Analysing Non-surgical Treatment Strategies to Cure Pes Planovalgus Associated Complaints

Pes planovalgus, also called flat foot, is a common foot deformity characterized by a flattening of the foot's longitudinal arch and is accompanied by a dysfunction of the posterior tibial tendon ("posterior tibial tendon dysfunction" or "PTTD"). Early stages of this pathology are thought to be treated with non-surgical therapy options like foot orthoses (relief of tendon stress by mechanical unloading of the arch), strengthening exercises or basic physiotherapeutic measures. Recent literature clearly states the urgent need for high quality studies to evaluate the proposed non-surgical treatments (Bowring 2009, 2010). There is only one high quality study available that shows benefits of orthoses therapy and exercise (Kulig 2009). No study to date evaluated functional changes pre-post in dynamic movement pattern like gait or stair climbing. The widespread use of several non-surgical treatment strategies lead to extensive financial expenses of the health care system. An optimized therapeutic strategy could eventually lead to more efficient health care investments. The presented proposal addresses this latest knowledge and aims to analyse non-surgical treatment strategies to Cure Pes Planovalgus associated Complaints (CurePPaC) in the CurePPaC Study.
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NewsBot · May 1, 2013

Pharmacokinetics and Safety Study of ME1111 in Moderate to Severe Onychomycosis Patients

The purpose is to determine the safety, tolerability, systemic exposure and pharmacokinetics of ME1111 after repeated daily topical application of ME1111 in a maximal use setting in adults with distal subungual onychomycosis of the toenails.
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NewsBot · May 11, 2013

Phase 3 Study Evaluating Efficacy and Safety of DSC127 Compared With Vehicle and With Standard-of-care in Diabetic Foot Ulcers (STRIDE 2)

To determine if DSC127 is effective in increasing incidence of complete wound closure up to 10 weeks confirmed 2 weeks later, compared with vehicle (gel without active ingredient) and compared with a standard-of-care gel, in subjects with diabetes mellitus (DM) who have chronic Wagner Grade 1 or 2 diabetic foot ulcers, 1 - 6cm2 in size.
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NewsBot · May 11, 2013

Resin vs. Amorolfine vs. Terbinafine Treatment in Onychomycosis

The aim of this prospective, investistigator-blinded, randomized and controlled clinical trial is to explore potential differences between 5 % amorolfine and 30 % resin lacquer in topical treatment of onychomycosis. In addition, topical treatment methods are compared with the most effective 'drug of choice' for onychomycosis according the current guidelines i.e. oral medication with terbinafine.

Altogether 90 patients (30 patients per group) who have culture or KOH stain verified onychomycosis are randomly allocated into three treatment groups to receive either topical treatment or oral medication for toe- or fingernail onychomycosis classified according to the current guidelines as follows:

White superficial onychomycosis (WSO)
Distal and lateral subungual onychomycosis (DLSO)
Proximal subungual onychomycosis (PSO)
[Total dystrophic onychomycosis) (TDO)] [Excluded]
[Candidal onychomycosis] [Excluded]

Participants are randomized into three groups to receive:

Topical treatment: 30 % resin lacquer (Abicin®)
Topical treatment: 5 % amorolfine lacquer (Loceryl®)
Oral medication: 250 mg terbinafine

All patients visit at outpatient department before the launch of the study, and three and nine months thereafter. Clinical examination is done by four physicians. At every visit, the panel of laboratory tests (S-Krea, S-GT, B-TVK), nail samples for mycological culturing and KOH staining (Sk-SienVi), and digital photographs are taken from the most severely affected onychomycotic nails. At the end of the study, all patients are ordered to discontinue using the resin- or amorolfine lacquer four weeks before the last visit (washout period). During the trial, all participants are contacted at least twice by phone in order to monitor the patient's compliance and willingness to continue in the trial.

In order to control safety and assess potential contraindications for terbinafine, amorolfine or resin, blood samples regarding kidney and liver function are taken in the beginning of the study, as well as at three and nine months, thereafter. The patients' permanent medication is verified against terbinafine, amorolfine and resin in order to exclude potential cross-reactions between the patient's permanent medication and current antifungal treatment. Sensitivity or allergy for terbinafine, amorolfine or resin is taken into account, and if any symptoms of allergic reactions appear, the study is discontinued for this particular patient.
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NewsBot · May 22, 2013

Study of Human Placenta-derived Cells (PDA002) to Evaluate the Safety and Effectiveness in Subjects With PAD and DFU

This clinical study is being conducted to assess the safety and determine the maximum tolerated dose (MTD) of PDA-002 [human placenta-derived cells] administered into the lower leg muscles of subjects with peripheral arterial disease and diabetic foot ulcers. It will look to see if PDA-002 helps reduce some of the symptoms of PAD and/or improves ulcer healing. This study will also help to find the best dose of PDA-002 to use in future studies.
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NewsBot · May 22, 2013

A Comparative Efficacy Study: Treatment for Non-healing Diabetic Foot Ulcers

The primary objective of this study is to assess the effectiveness of MatriStem devices compared to cellular dermal replacement tissue, for the treatment of non-healing diabetic foot ulcers.
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NewsBot · Jun 1, 2013

Efficacy of Foot Orthotics in Veterans With Chronic Lower Back Pain
Foot Levelers, Inc.
New York Chiropractic College

A randomized sham controlled trial evaluating the efficacy of the use of custom foot orthotics in veterans suffering from chronic lower back pain. The current study hypothesizes that those veterans with chronic lower back pain who receive the custom foot orthotics will show greater improvements in pain and disability associated with the chronic lower back pain than those who receive the sham orthotic.
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NewsBot · Jun 1, 2013

Comparison of Usual Podiatric Care and Early Physical Therapy for Plantar Heel Pain

Plantar heel pain (PHP) is one of the most common foot conditions in podiatry and physical therapy practice and often is associated with chronic symptoms, and disability. Persistence of symptoms adds to the economic burden of PHP and cost-effective solutions are needed to reduce this burden. Currently, there is wide variation in treatment, cost, and outcomes of care for PHP. Two practice guidelines are available to direct management patterns, but the guidelines and recent evidence of PHP interventions are unclear about the timing and influence of physical therapy in the multidisciplinary management of PHP. The purpose of this investigation is to compare the outcomes and costs associated with early physical therapy (ePT) following initial presentation to podiatry versus usual podiatric care (uPOD) in individuals with PHP. It is hypothesized that there will be greater improvement and/or reduced costs associated with either ePT or uPOD. In this study, 112 individuals with PHP will be randomized to receive uPOD or ePT after an initial visit with a podiatrist. Treatment provided in the uPOD group will reflect usual management patterns and intervention will be determined by the podiatrist. Treatment provided in the ePT group will be determined by the physical therapist and will focus on impairment-based manual therapy and exercise to the lower half of the body. In addition, evidence-based pain modulating modalities will be integrated into ePT treatment. Comparisons will be made between groups in the Foot and Ankle Ability measure, the European Quality of Life, Numeric Pain Rating Scale, Global Rating of Change (GROC), and cost of treatment at 6, 26, and 52, weeks. The association between successful outcome based on GROC score and patient expectation of physical therapy or podiatry, and general expectations of symptom improvement will be analyzed. The results of this investigation will help to determine the impact of ePT to inform practice, update existing guidelines to reduce practice variation, and identify the most cost effective treatment for patients with PHP.
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NewsBot · Jun 4, 2013

Study of Changes in the Feet With Pregnancy

This research is being conducted to determine whether use of an arch-supporting insole during pregnancy prevents alterations in foot structure and lower limb rotational movements. The investigators hypothesize that the arch collapse during pregnancy will be significantly reduced in women randomized to use the supportive insole compared with women randomized to the control group.
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NewsBot · Jun 6, 2013

Combination of Lateral Foot Orthoses and Knee Brace for Treatment of the Knee Osteoarthritis

The purpose of this study is to evaluate the immediate and short-term effects of the combination of lateral customized foot orthoses on the pain and medial knee loading during gait among medial knee osteoarthritis patients. The effects of the combination is compared to the single use of these devices. The investigators recruited 22 knee osteoarthritis. They have to wear each of treatments (foot orthoses, knee brace and combination) during three months. A fifteen days wash-out period is given after each three months. Biomechanical evaluation is carried out before and after each three months. This evaluation consisted of three questionnaires (KOOS, WOMAC and MOS-SF36), a motion analysis with an optoelectronic system, then a 6-min walk test. During motion analysis, ten gait trials are executed without treatment and ten with the treatment.
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NewsBot · Jun 18, 2013

A Study to Evaluate the Performance of VibraTip® by Different Clinical Users

VibraTip® is a pocket-sized, wipe-clean, disposable device that provides a consistent source of gentle vibration. It has been specifically designed to overcome the limitations of tuning forks for testing the integrity of vibration sense in clinic and by the bedside. The product is a hand held device that is used to examine the feet of Diabetic patients who are susceptible to peripheral neuropathy that can in turn lead to ulcers. Treatment is expensive and can be over a period of time, often not being completely resolved, and can lead to amputation. The product will increase awareness of foot care and achieve a reduction in incidence of foot ulcers.

The study aims to evaluate the accuracy of the VibraTip device compared to the Gold Standard, the 10g Semmes Weinstein Monofilament (MF) Test, and the accuracy and usability of the VibraTip® device, as measured by different community medical practitioners.
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NewsBot · Jun 21, 2013

Efficacy of a Custom Temporary Foot Orthosis for Plantar Fasciitis Treatment

The aim of this randomized control trial is to identify the possible effectiveness of the temporary use of an inexpensive, custom-made plantar fascia orthotic (PFO).
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NewsBot · Jul 18, 2013

Astym® Compared Eccentric Exercise for Chronic Mid-substance Achilles Tendinopathy

The purpose of this study is to compare the changes in pain and self-perceived function between two different treatments for Achilles tendinopathy: the Astym® protocol (a form of soft tissue mobilization using instruments) and a specific exercise protocol that involves strengthening the calf and Achilles tendon. Astym® (A-stim) is not an acronym, but rather stands for "A Stimulation" of the body's healing response, describing the physiologic process which occurs with Astym treatment. Astym is the trademark name of a non-invasive treatment where instruments are applied topically to locate unhealthy soft tissue, and to transfer mild to moderate pressure to the underlying soft tissue structures. The aim of Astym treatment is to eliminate scar tissue and stimulate tissue regeneration. Both the principal investigator and co-investigator have been trained and certified in administering the Astym treatment. The specific exercise protocol will involve exercises that strengthen the Achilles and calf through eccentric exercise. Eccentric exercise is a form of exercise where the benefit comes from applying a controlled lengthening stress to the muscle and tendon.
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NewsBot · Aug 9, 2013

Evaluation Study for the Efficacy and Safety of PinPointe FootLaser in Treatment for Onychomycosis

The purpose of this study is to assess the clinical efficacy and safety of the PinPointe Foot Laser device for the treatment of patients with onychomycosis who have been previously treated with oral Terbinafine and failed.
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NewsBot · Aug 23, 2013

A Multi-centre, Controlled Clinical Trial to Evaluate the Safety and Efficacy of the Wound Wand™ Debridement Device on Infection Prevention (WW)

Controlled, multi-center clinical trial intended to assess the safety and efficacy of the WoundWand™ debridement device
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NewsBot · Aug 23, 2013

A Prospective Randomized Comparison of Three Methods for Fixation of Hammertoes

The purpose of this research project is to compare three different methods for fixation of hammertoe deformities: (1) Kirschner wire; (2) Integra IPP-ON PIP Fusion System; and (3) Stryker Smart-Toe implant.
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NewsBot · Aug 29, 2013

Botulinum Toxin Treatment in Craniofacial, Inguinal, Palmar, Plantar and Truncal Hyperhidrosis

Hyperhidrosis is defined as excessive sweating and affects about 2.8 % of the population.

It has been shown to have a deleterious effect on the quality of life measured using the Dermatology Life Quality Index (DLQI) which is one of the most widely used dermatology-specific quality of life instruments. This is comparable to the effect on quality of life in patients with severe psoriasis of the skin as well as to nodulocystic acne patients before treatment with oral isotretinoin.

The clinical effect of Botulinum Toxin (Btx) A has been established in three randomized controlled trials (RCT) in axillary hyperhidrosis. One RCT has indicated a positive effect in palmar hyperhidrosis. Although there is increasing evidence that Btx A and B have a similar effect on hyperhidrosis of other parts of the body (ie hyperhidrosis of the face, trunk, groin and feet) which is reported in case-reports and open studies there is still a great need for more controlled studies. This is why we will carry out this randomized, double-blind, placebo-controlled study to investigate the clinical effect and safety of Btx A in palmar, plantar and inguinal (groins/buttocks) hyperhidrosis and the clinical effect and safety of Btx B in craniofacial and truncal hyperhidrosis, respectively. Besides using the DLQI instrument we will also study Btx A/B to elucidate the impact of this treatment on quality of life using a generic instrument, the effect on anxiety and depressive symptoms, sweating, and patients´global assessment of therapy.
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NewsBot · Sep 20, 2013

The Effects of Ankle Foot Orthoses (AFOs) on Mobility in Persons With Multiple Sclerosis (MS)
This study is not yet open for participant recruitment.

The purpose of this study is to investigate the impact of ankle foot orthoses (AFOs) on the spatial and temporal gait parameters, electromyography (EMG), walking endurance, and quality of life in select individuals living with MS. The hypotheses of the study are: 1. Individuals who are fit with an AFO will demonstrate improvements in spatial and temporal gait parameters 2. Individuals who are fit with an AFO will demonstrate improvements in walking endurance. 3. Individuals who are fit with an AFO will demonstrate improvements in muscle firing profiles/EMG measures. 4. Individuals who are fit with an AFO will demonstrate improvements in quality of life.
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NewsBot · Sep 23, 2013

Insole Optimisation for Ulcer Prevention: a Feasibility Trial

Insoles are designed to reduce increased loads and re-ulceration risk in patients with diabetes. The investigators previous research findings suggest that an instant insole solution may benefit some, but effectiveness is difficult to predict. The investigators propose a feasibility study using in-shoe pressure analysis to optimise the protective effect of insoles and footwear with the aim of reducing re-ulceration rates.

Early indications from exploratory case studies within the real world clinical setting suggest that by implementing the investigators previous published research findings the investigators can optimise effectiveness and reduce outcome variability of protective footwear and insoles provided to patients at risk of re-ulceration.

However a further randomised control trial is necessary to evaluate the effectiveness of in-shoe pressure analysis in reducing re-ulceration rates within the NHS setting. The proposed feasibility study will recruit 20 participants from the multidisaplinary diabetic foot clinic Derriford Hospital and allocate them to either 1) Routine insoles and footwear provision or 2) Routine insole and footwear provision, and temporary insole provision with optimisation. The findings from the feasibility study will inform protocol development for a larger clinical trial. The results of the feasibility study will be used to strengthen a protocol for a grant application to conduct the main RCT. A secondary output from the pilot study will be the dissemination of findings in a peer reviewed journal and at conference.
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NewsBot · Sep 27, 2013

Efficacy and Safety of Garamycin in Diabetic Patients With a Moderate or Severe Foot Ulcer Infection

The purpose of this study is to determine whether Garamycin in combination with antibiotics is safe and effective in treating moderate and severe diabetic foot infections.
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NewsBot · Sep 27, 2013

Effects of a Homeopathic Anti-inflammatory Topical Cream on Ulcers and Neuropathy in the Diabetic Foot

This is a study whose primary objective is to assess the effectiveness of Neuropathy/Ulcer Cream in the promotion of healing skin fissures plantar foot ulcers and as a moisturizer to prevent dry skin turning into ulcers as compared with a placebo cream containing the same vehicle as Neuropathy/Ulcer Cream without the active ingredients (Control).
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NewsBot · Sep 30, 2013

Initial Effects of Kinesiotaping in Non Surgical Treatment of Hallux Valgus

The main aim of this study was to find the initial effects of kinesiotaping on pain and joint alignment used in the conservative treatment of hallux valgus.
22 female patients diagnosed with hallux valgus participated in this study. Kinesiotaping was implemented after the first assessment and renewed in the 3rd, 7th and 10th days. The main outcome measures were the pain hallux adduction angle. Kinesiotaping may be an effective treatment option in decreasing pain and deformity in hallux valgus deformity who are conservatively treated. In future studies this method might be shown in larger sample groups at longer periods of treatment comparing with alternative treatment approaches like exercise or orthotics.
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NewsBot · Oct 7, 2013

Hyperbaric Oxygen for Wagner II Diabetic Lower Extremity Ulcers

The purpose of this proposed DoD study is to determine if hyperbaric oxygen therapy (HBOT) plus standard wound care is more effective than standard wound care alone in the rate of healing and prevention of major amputation (metatarsal and proximal) in Wagner grade 2 diabetic lower extremity ulcers.
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NewsBot · Oct 8, 2013

Evaluation of a New Device "Orthèse Diabète" in the Healing of Foot Ulcers in Diabetic Patients (ORTHODIAB)

Multi-center trial, randomized in 2 parallel groups, open label, with a blinded adjudication committee (PROBE methodology), comparing "Orthèse Diabète" with "conventional" removable devices in terms of healing of ulcers.

- Primary objective: Evaluate the efficiency of "Orthèse Diabète" compared to "conventional" removable devices, in terms of the proportion of diabetic patients whose principal ulcer will heal completely at 3 months.
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NewsBot · Oct 8, 2013

Comparing Steroid Injections and Platelet Rich Plasma Injections in the Treatment of Plantar Fasciitis

In cases of Plantar Fasciitis not responding to conservative management, minimally invasive techniques may be used. These include platelet rich plasma injections and corticosteroid injections. Corticosteroids have long been used for symptomatic relief. However there are growth factors present in PRP injections that contribute to the healing of the pathology, and not just symptom control.

A single blind, prospective, randomized, comparative, control study will be performed. The study population consists of a total of 80 participants. They will be randomly assigned to receive either a corticosteroid injection, or a platelet rich plasma injection. Data will be collected through questionnaires and ultrasound findings. Patients will have a follow up at 3, 6, 12, and 24 weeks after they receive their injection.
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NewsBot · Oct 8, 2013

Intensive Insulin Treatment and Ischemic Foot Ulcer

We aim to investigate the relationship between skin microvascular function and the first hospitalization for ischemic foot ulcer in patients with type 1 diabetes former randomized during 7.5 years to intensified conventional insulin treatment (ICT) compared to standard insulin treatment (ST).
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NewsBot · Oct 16, 2013

Cutaneous Microcirculation and Diabetic Foot (M2P2)

15% of diabetics have a diabetic foot (DF) in their lives associated with a risk of amputation and mortality two times greater than that of a diabetic population without DF. Predicting the occurrence of an DF is limited and only the occurrence of a diabetic wound up involved assessment and treatment. Our team is behind the discovery of the Pressure-Induced Vasodilation (PIV) first observed in healthy subjects after local application of a gradual pressure on the skin leading to cutaneous vasodilation at the application of pressure. This gain in blood flow delays the onset of ischemia. However the involvement of PIV in the DF, which is also a pressure-induced skin lesion, remains to be demonstrated in diabetic subjects. The main objective of this study is to show that PIV, a functional examination of the cutaneous microcirculation we developed, is altered in the presence of DF, taking into account the influence of age and neuropathy.
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NewsBot · Oct 30, 2013

This clinical trial was just registered:
Foot Neuromodulation for Overactive Bladder (OAB) (FootStim)

The purpose of this study is to determine if electrical stimulation of the foot is effective in the treatment of overactive bladder conditions.
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Foot neuromodulation is designed to treat OAB conditions by electrically stimulating the somatic afferent nerves in the foot using skin surface electrodes. The foot stimulation is non-invasive, can be performed at home, and has no adverse effects. Foot neuromodulation therapy will likely be accepted by more patients and have the potential to make a broader impact on the improvement of OAB conditions.
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NewsBot · Nov 13, 2013

Sonoelastographic Changes After Low Energy Extracorporeal Shock Wave Therapy (ESWT) in Plantar Fasciitis

Extracoporeal shock wave therapy(ESWT) was perfomed on the plantar fascia of chornic plantar fasciitis patients. Pre-ESWT and post-ESWT pain intensity, sonography and sonoelastrography of the plantar fascia was checked. Our hypothesis is that the plantar fascia stiffness increased after ESWT as clinical symptom improves.
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NewsBot · Nov 20, 2013

Eccentric Exercise Versus Eccentric Exercise and Astym for Insertional Achilles Tendinopathy

The purpose of this research study is to determine if Astym® (instrument assisted soft tissue mobilization) is an effective treatment for patients with Achilles pain. The usual treatment for this condition is a specific exercise program that has been previously shown to be effective. The research team is trying to determine if combining Astym with the exercise program is more effective than exercise program only.

The main hypothesis for this study is that Astym plus eccentric exercise will be more effective than eccentric exercise alone at improving pain and function in patients with insertional Achilles tendinopathy
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NewsBot · Nov 28, 2013

Laser Therapy for Onychomycosis in Patients Wih Diabetes at Risk for Diabetic Foot Complications (LASER-1)

Rationale: Onychomycosis is an important problem for patients with diabetes. Nails with fungal infection become thick and distorted with resulting pressure increase and the potential for serious complications like diabetic foot ulcers. As part of the diabetic foot care program, nails of patients at risk for developing ulcers and suspected onychomycosis are frequently skived. There is no effective local therapy that cures infection; systemic antifungal medication are often withheld due to concerns for interactions with other drugs and side effects.

Aim: To determine the efficacy of Nd:YAG laser therapy to treat onychomycosis in diabetes patients with risk factors for developing diabetic foot complications.

Setting: A randomized, double blind, controlled trial. Study population: Patients with diabetes mellitus, with an increased risk for diabetic ulcers.

Intervention: local laser treatment from a podiatrist and the other group receives treatment according to a control procedure. The later procedure will be performed as a sham procedure by a second podiatrist.

Main study parameters/endpoints: The effect of 4 sessions of laser therapy on cure rate (clinical and microbiological) after one year.
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NewsBot · Dec 24, 2013

Laser Treatment for Onychomycosis in Diabetes

Fungal infections of the toe affect one in three people with diabetes. Current treatments for fungal toe infections include oral medications, but these drugs often interact with other common medications. The investigators are studying a new treatment for fungal toe infections involving the use of a laser device. The investigators will compare to the standard treatment which is a type of antifungal cream. This laser has been tested in small numbers of patients with minimal side effects. There will be 80 participants selected for our study, of which 40 will receive standard treatment and the rest will receive laser treatment.
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NewsBot · Dec 28, 2013

Efficacy and Safety Study of ME1111 in Patients With Onychomycosis

The purpose of the study is to determine the safety and efficacy of high and low strength of ME1111 solutions compared to the vehicle in the treatment of onychomycosis of the toenail.
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NewsBot · Dec 31, 2013

Efficacy of Teriparatide in Diabetic Inactive Charcot's Neuroarthropathy of Foot.

Diabetic foot represents a major medical , social and economic problem worldwide.

Charcot's neuroarthropathy, being a common cause of diabetic foot, has been an intriguing topic of research for endocrinologists, podiatrists and surgeons. After its first description by JEAN-MARTIN CHARCOT in 1868, many theories have been put forward regarding its pathophysiology , but not much research has been done for its prevention and treatment , specially the inactive stage.

The course of Charcot 's neuroarthropathy is triphasic , with the diagnosis being usually missed in the active stage, henceforth the patients often come to us with a deformed foot. As a consequence , the osteoclastic activity in active stage renders the foot bones demineralized and weak, thus being susceptible to fracture and fragmentation.

Teriparatide is recombinant human (1-34) parathyroid molecule that has been approved for post-menopausal osteoporosis and in men with primary or secondary osteoporosis. It acts by preferentially stimulating osteoblast over osteoclast activity resulting in new bone formation and an increase in the rate of bone remodeling which manifest as an increase in skeletal mass and bone mineral density .

Keeping the pathophysiology of Charcot's foot in mind, teriparatide may be used as potential treatment for inactive Charcot's neuroarthropathy but there are no studies or randomized trials in this setting, till date. We hypothesize that teriparatide may increase the remodeling of foot bones in Charcot's neuroarthropathy, improve bone mineral density, subsequently leading to a reduction in the risk of fractures and progression of deformities. This study plans to compare the effects of teriparatide in diabetes patients with inactive Charcot's foot in a placebo controlled design.
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NewsBot · Jan 2, 2014

Kinesio Taping Effectiveness on Idiopathic Toe Walking

Idiopathic Toe Walking (ITW) is a diagnosis normally of exclusion and likely, consequently, is approached in vastly varying ways of intervention, including serial casting, Botox injections and physical therapy. There is some evidence in the literature that children with ITW can somewhat correct their lack of heel-strike gait pattern at least temporarily. Kinesio Taping (KT) method is an intervention that is used in the outpatient physical therapy setting for various conditions such as post-operative edema, muscle facilitation of weakened rotator cuff muscles, and functional corrections in children with torticollis. This pilot study will strive to determine if KT may be effective by providing proprioceptive and neuromuscular re-education through thermal and mechanical fascial impositions, thereby improving passive joint range of motion (ROM) through reduction of passive muscle stiffness and improving ambulation through neuromuscular re-education in children with idiopathic toe walking. We will quantify passive muscle stiffness of the gastrocnemius and opposing anterior tibialis using non-invasive Shear Wave Elastography (SWE). Further we look at the kinematics and kinetics of the child's ankle during the gait cycle to further determine any effect(s) of KT on functional walking outcome measures. The intent is that the results from this study will serve as a platform from which to expound look at the long-term, if any, effects of KT on the muscle property and gait cycle pattern in children with ITW.
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NewsBot · Jan 15, 2014

Safety and Efficacy of Gentamicin Topical Gel (AppliGel-G) for Treatment of Mild to Moderately Infected Diabetic Foot Ulcers

The purpose of this study is to determine whether AppliGel-G (Gentamicin topical gel) plus oral Ciprofloxacin / Doxycycline are safe and effective in the treatment of mild to moderately infected foot ulcers in diabetic patients.
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NewsBot · Jan 22, 2014

Hyperbaric Oxygenation in Diabetic Ulcer

Hyperbaric oxygenation (HBO) involves breathing of 100% oxygen under elevated ambient pressure. In correlation to the pressure level oxygen dissolves in the plasma resulting in an increase of total oxygen in the body. The elevated tissue levels of oxygen may persist for hours, instigating healing processes in wounds caused by disturbances in of perfusion in small vessels, a condition often found in patient with diabetes.

We plan a prospective, double-blind randomized clinical study in 80 patients with chronic diabetic ulcer. All will have optimum treatment of diabetes. The HBO group will be given HBO at 2.4 bar, 90 min., 30 sessions, controls will have sham HBO. Routine wound care will be identical in both groups. Before, during and after treatment (3, 6 and 12 months), a number of monitoring and imaging procedures will be done, cells in the bloodstream indicating improved healing will be determined.

Hypothesis: HBO will instigate the healing process in the majority of patients with chronic diabetic leg ulcer, provided the patency of the large vessels is given.
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NewsBot · Feb 1, 2014

Hard-soled Shoe Versus Short Leg Walking Cast for a Fifth Metatarsal Avulsion Fracture: A Randomized Multicenter Noninferiority Trial

Fifth metatarsal avulsion fractures are common and can usually be treated conservatively. Symptomatic care consisting of protected weightbearing in a hard-soled shoe, air-cast walking boot, or below-knee walking cast have been successful. Several papers reported that early rehabilitation may decrease ankle stiffness, muscle and bone atrophy, and aids in early return to activities. However, early motion of the ankle joint may have the risk of displacement of the fifth metatarsal avulsion fractures. However, studies using hard-sole shoe for protected weightbearing and allowing motion of the ankle joint had successful results. Clapper et al. compared the results of hard-soled shoe and walking cast for a fifth metatarsal avulsion fracture and reported that all avulsion fractures healed uneventfully and that the results were similar between the two. However, this was not a randomized controlled trial.

Devices such as air-cast walking boot, plaster slipper, or Jone's dressing can also be used for the treatment. However, we decided to compare results of hard-soled shoe and short leg walking cast for the treatment of a fifth metatarsal avulsion fracture.

We hypothesized that the 100mm visual analogue scale (VAS) assessed on 6 months after a fifth metatarsal avulsion fracture treated with protected weightbearing in a hard-soled shoe is not inferior to protected weightbearing in a short leg walking cast but is superior to short leg walking cast with respect to time to return to normal daily life and patient's satisfaction.
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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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