Clinical Trials Updates

admin · Mar 27, 2008

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The registration of clinical trials prior to the start of a clinical trial is now extremely important part of the protocol. Here is a statement from International Committee of Medical Journal Editors on Clinical trial Registration

Altruism and trust lie at the heart of research on human subjects. Altruistic individuals volunteer for research because they trust that their participation will contribute to improved health for others and that researchers will minimize risks to participants. In return for the altruism and trust that make clinical research possible, the research enterprise has an obligation to conduct research ethically and to report it honestly. Honest reporting begins with revealing the existence of all clinical studies, even those that reflect unfavorably on a research sponsor's product.
Unfortunately, selective reporting of trials does occur, and it distorts the body of evidence available for clinical decision-making. Researchers (and journal editors) are generally most enthusiastic about the publication of trials that show either a large effect of a new treatment (positive trials) or equivalence of two approaches to treatment (non-inferiority trials). Researchers (and journals) typically are less excited about trials that show that a new treatment is inferior to standard treatment (negative trials) and even less interested in trials that are neither clearly positive nor clearly negative, since inconclusive trials will not in themselves change practice. Irrespective of their scientific interest, trial results that place financial interests at risk are particularly likely to remain unpublished and hidden from public view. The interests of the sponsor or authors notwithstanding, anyone should be able to learn of any trial's existence and its important characteristics.
The case against selective reporting is particularly compelling for research that tests interventions that could enter mainstream clinical practice. Rather than a single trial, it is usually a body of evidence, consisting of many studies, that changes medical practice. When research sponsors or investigators conceal the presence of selected trials, these studies cannot influence the thinking of patients, clinicians, other researchers, and experts who write practice guidelines or decide on insurance-coverage policy. If all trials are registered in a public repository at their inception, every trial's existence is part of the public record and the many stakeholders in clinical research can explore the full range of clinical evidence. We are far from this ideal at present, since trial registration is largely voluntary, registry data sets and public access to them varies, and registries contain only a small proportion of trials. In this editorial, published simultaneously in all member journals, the International Committee of Medical Journal Editors (ICMJE) proposes comprehensive trials registration as a solution to the problem of selective awareness and announces that all eleven ICMJE member journals will adopt a trials-registration policy to promote this goal.
The ICMJE member journals will require, as a condition of consideration for publication, registration in a public trials registry. Trials must register at or before the onset of patient enrollment. This policy applies to any clinical trial starting enrollment after July 1, 2005. For trials that began enrollment before this date, the ICMJE member journals will require registration by September 13, 2005, before considering the trial for publication. We speak only for ourselves, but we encourage editors of other biomedical journals to adopt similar policies. For this purpose, the ICMJE defines a clinical trial as any research project that prospectively assigns human subjects to intervention or comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome. Studies designed for other purposes, such as to study pharmacokinetics or major toxicity (e.g., phase 1 trials), would be exempt.
The ICMJE does not advocate one particular registry, but its member journals will require authors to register their trial in a registry that meets several criteria. The registry must be accessible to the public at no charge. It must be open to all prospective registrants and managed by a not-for-profit organization. There must be a mechanism to ensure the validity of the registration data, and the registry should be electronically searchable. An acceptable registry must include at minimum the following information: a unique identifying number, a statement of the intervention (or interventions) and comparison (or comparisons) studied, a statement of the study hypothesis, definitions of the primary and secondary outcome measures, eligibility criteria, key trial dates (registration date, anticipated or actual start date, anticipated or actual date of last follow-up, planned or actual date of closure to data entry, and date trial data considered complete), target number of subjects, funding source, and contact information for the principal investigator. To our knowledge, at present, only www.clinicaltrials.gov, sponsored by the United States National Library of Medicine, meets these requirements; there may be other registries, now or in the future, that meet all these requirements.
Registration is only part of the means to an end; that end is full transparency with respect to performance and reporting of clinical trials. Research sponsors may argue that public registration of clinical trials will result in unnecessary bureaucratic delays and destroy their competitive edge by allowing competitors full access to their research plans. We argue that enhanced public confidence in the research enterprise will compensate for the costs of full disclosure. Patients who volunteer to participate in clinical trials deserve to know that their contribution to improving human health will be available to inform health care decisions. The knowledge made possible by their collective altruism must be accessible to everyone. Required trial registration will advance this goal.
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The purpose of this thread is to update with new trials that are registered at various sources related to the foot, lower limb and podiatry.

admin · Mar 27, 2008

Here are the first batch:
The Development of Flat Foot After Ankle Fractures
Safety & Efficacy Study for the Use of Extracorporeal Shockwaves in the Treatment of Diabetic Foot Ulcers
Clinical Trial to Evaluate the Efficacy and Safety of Sodium Bemiparin for Treating Ulcers in Diabetic Foot
Bi-Axial Rotating Magnetic Field Therapy in Refractory Neuropathic Foot Pain Secondary to Diabetic Peripheral Neuropathy
Clinical Evaluation of Placement of Radiofrequency-Based Plasma Microdebridement in the Treatment Algorithm for Foot and Ankle Tendinosis and Plantar Fasciosis
Foot and Ankle Range of Motion (Stretching) Apparatus
Treatment of Recalcitrant Hand and Foot Warts With Intense Pulsed Light - a Randomized Controlled Trial
Evaluating the Effects of Foot Orthotics on Plantar Pressures in the Diabetic Population
Plantar Fasciosis Treatment Using Coblation
Treatment of Plantar Fasciitis With Dorsiflexion Night Splints and Medial Arch Supports
Influence of Leg Length Discrepancy on the Spinal Shape and Biomechanics in Functional and Idiopathic Scoliosis Patients
Wound Healing: Total Contact Cast Vs. Custom-Made Temporary Footwear for Patients With Diabetic Foot Ulceration
The Effect of Custom-Made Biomechanical Perturbation Platform on Kinetics, Kinematics and Electromyography in Healthy Subjects
Exercise and Shoe Orthoses in Treatment of Posterior Tibial Tendon Dysfunction
Comparison of Alcohol and Steroid Injection for Treating Morton's Neuroma

Kent · Mar 27, 2008

We've used the Australian New Zealand Clinical Trials Registry - http://www.anzctr.org.au.

Are others in Australia using ANZCTR or clinicaltrials.gov?

admin · Mar 28, 2008

Kent said: ↑

We've used the Australian New Zealand Clinical Trials Registry - http://www.anzctr.org.au.

Are others in Australia using ANZCTR or clinicaltrials.gov?
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There are a number of registries that we setting in place systems to monitor:

1. Australian New Zealand Clinical Trial Registry (Australia) http://www.anzctr.org.au
2. ClinicalTrials.gov (USA) http://www.clinicaltrials.gov
3. ISRCTN Register (UK) http://www.ISRCTN.org
4. UMIN Clinical Trials Registry (Japan) http://www.umin.ac.jp/ctr/index/htm
5. Netherlands Trial Register (The Netherlands) http://www.trialregister.nl
6. Clinical Trials Registry (India) http://www.ctri.in/
7. Chinese Clinical Trials Register (China) http://www.chictr.org/
8. South African National Clinical Trials Register (SANCTR) http://www.sanctr.gov.za/

admin · Mar 28, 2008

Topical Collagen-Silver Versus Standard Care Following Removal of Ingrown Nails
Spread of Dermatophytes Among Families
A Study to Evaluate Efficacy and Safety of Three Albaconazole Regimens With Placebo in the Treatment of Moccasin Type Tinea Pedis (MTTP)

NewsBot · Mar 28, 2008

bLAC - Treatment of Cutaneous Warts in Immune Suppressed, Kidney Transplanted Patients

admin · Mar 29, 2008

Kent said: ↑

We've used the Australian New Zealand Clinical Trials Registry
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Randomised Clinical Trial of Prolotherapy Injections and Eccentric Loading Exercises for Painful Achilles Tendinosis

admin · Apr 2, 2008

Randomized Controlled Trial Comparing Medical and Medical-Surgical Treatment in Diabetic Foot Osteomyelitis (DIPIOS)

NewsBot · Apr 2, 2008

Plantar Fasciitis Treated With Dynamic Splinting

NewsBot · Apr 10, 2008

Neuroma Injections to Treat Restless Legs Syndrome - RCT

NewsBot · Apr 11, 2008

Efficacy and Safety Study of 4975 to Manage Pain of Bunionectomy

NewsBot · Apr 15, 2008

Target Site Pharmacokinetics of Ertapenem After Multiple Doses in Diabetes Patients With Soft Tissue Infection

NewsBot · Apr 16, 2008

Prevention of Infection Using a Topical Gentamicin-Collagen Sponge in Diabetic Patients With An Uninfected Foot Ulcer

The Safety and Efficacy of an Antibiotic Sponge in Diabetic Patients With Moderately Infected Foot Ulcers

NewsBot · Apr 21, 2008

Study Of The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients

NewsBot · May 28, 2008

Safety and Efficacy Study of TG-873870 (Nemonoxacin) in Diabetic Foot Infections

NewsBot · May 31, 2008

Effectiveness of Intensive Lipid Modification Medication in Preventing the Progression of Peripheral Arterial Disease (The ELIMIT Study)

Peripheral arterial disease (PAD) occurs when arteries become narrowed or hardened because of a build-up of plaque or fat deposits. PAD develops most often in arteries in the legs, which can result in reduced blood flow to the legs and feet, occasionally causing leg pain and fatigue. Early identification of PAD and treatment with lifestyle changes or medications can help to keep legs healthy and lower risk for heart attack and stroke, but endovascular or surgical procedures may be necessary for people with severe PAD. Even after endovascular intervention, PAD symptoms must be continually monitored to prevent the development and progression of blockages in the arteries. The best approach for monitoring symptoms is still undetermined. This study will compare the effectiveness of an intensive combination of lipid modifying medications versus standard lipid modifying medications in treating people with significant PAD who have had an endovascular intervention.
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NewsBot · Jun 4, 2008

A Comparison of Steel and Bioabsorbable Screw Fixation of Lisfranc Foot Injuries

I hypothesize that absorbable screw fixation of the foot's Lisfranc ligaments does not yield significant differences in postoperative foot stability, ligament function, and symptoms when compared to steel screw fixation. In addition, absorbable screw fixation of the Lisfranc ligaments offers the advantage that a second surgical procedure to remove the screw is not necessary.
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NewsBot · Jun 6, 2008

Negative Pressure Wound Therapy for the Treatment of Chronic Pressure Wounds (NPWT)

The purpose of this study is to assess the difference in the percent reduction in wound surface area, without surgery, of chronic pressure ulcers of the pelvic region for Negative Pressure Wound Therapy (NPWT) compared to standard dressing.This study is designed to provide evidence regarding NPWT as compared to standard dressing regimens and compare the efficacy, safety, effectiveness and cost-effectiveness.
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NewsBot · Jun 19, 2008

This clinical trial has just been registered:
Insulin Infusion and Infectious Foot Ulcers(IIIFU)

Normoglycemia is important for the outcome of surgical and medical conditions. Insulin infusions have been studied to achieve normoglycemia during these circumstances and have proved to be useful. Insulin given by subcutaneous injections has longer duration compared to intravenous given insulin which makes it more difficult to control. The hypothesis behind the trial is the concept that insulin infusion is more effective in reaching normoglycemia in diabetic subjects during foot ulcer infection and surgical wound infection.

The study evaluates a target controlled insulin infusion or conventional therapy as antidiabetic treatment during foot ulcer infection and surgical wound infection.
Secondary efficacy parameter will be hospital stay, laboratories for inflammation and oxidative stress.
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Link to details of study

NewsBot · Jun 22, 2008

Podiatry treatment to improve balance and prevent falls in older people

Randomised controlled trial of a multifactorial podiatry intervention to improve balance and prevent falls in older people
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NewsBot · Jun 22, 2008

The CARROT trial: CAllus Reduction Reinforcing Orthotic Therapy

The CARROT trial: CAllus Reduction Reinforcing Orthotic Therapy - the effectiveness of sharp scalpel debridement of callus as a component of complex long-term interventions for painful forefoot plantar callosities in patients with rheumatoid arthritis
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This is a randomised controlled trial (RCT) of patients with rheumatoid arthritis (RA) and painful forefoot plantar callosities receiving either debridement of painful forefoot plantar callosities plus conservative therapies or conservative therapies alone.

Hypothesis:
The addition of repeated sharp scalpel debridement of callus to a long-term care plan offers no greater reduction in pain or improvement in functional status than a low-risk, long-term care plan based on conservative self care, footwear advice, padding and/orthoses.
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NewsBot · Jun 23, 2008

Study on the Role of Decompression of Lower Extremity Nerves for the Treatment of Patients With Symptomatic Diabetic Neuropathy With Chronic Nerve Compression (DNND)

Potential candidates for the study are patients who have symptomatic painful diabetic neuropathy who have not responded to medical treatment (glucose control, pain medications) for at least one year and continue to have severe pain.

It is thought today that one third of patients with diabetic neuropathy may have superimposed nerve compression in the nerves in the leg, or in other words the nerves may be pressed by the surrounding tissue. This nerve compression is what might be contributing to the pain, and often loss of sensation at the bottom of your feet. The principle is similar to carpal tunnel syndrome which is pressure of a nerve in the wrist. Carpal tunnel syndrome is seen in 14-30% of patients with diabetes compared to 2% in the general population.

This study involves one year of close care and follow-up. As a part of this study, you will have regular evaluations by a foot care specialist from Physical Medicine and Rehabilitation, receive glucose management tips from a Diabetic Nurse Educator, and also have specialized, non-invasive testing in the Neurology department. The care that you would receive for being a part of this study is highly exceptional due to the various departments involved and their dedication to this research.

Initial data supports success rates at around 80% in terms of significant alleviation of pain and restoration of at least protective sensation and long term follow ups have suggested decrease in prevalence of infections, ulcerations, and amputations.
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NewsBot · Jul 3, 2008

Clinical Evaluation of DCB-WH1 in Healing of Chronic Diabetic Foot Ulcers

The primary objective of this Phase 2 study is to evaluate the efficacy of DCB-WHI ointment in wound closure as compared to vehicle control when applied topically to chronic diabetic foot ulcers for 12 weeks. The secondary objective of this study is to collect safety information of DCB-WHI ointment.

This is a randomized, double-blind, parallel group, vehicle-controlled, multi-center study of DCB-WH1 ointment applied topically to grade 1 foot ulcers (according to Wagner grading system) in 40 subjects with diabetes mellitus.
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NewsBot · Jul 17, 2008

Hallux Limitus Treated With Dynamic Splinting: A Randomized, Controlled Trial

The purpose of this study is to regain range of motion of the great toe with dynamic splinting which will help reduce great toe's pain and swelling.
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Device: Metatarsophalangeal Extension Dynasplint System
Dynamic Splinting utilizes the protocols of Low-Load, Prolonged-Duration Stretch (LLPS) with calibrated, adjustable tension to increase the Total End Range Time (TERT) to reduce contracture. This unit is worn for 30 minutes, three times per day, (while seated or resting in bed) totaling 1.5 hours per day.
Other: Standard of Care
The current standard of care in treating Hallux Limitus will be given to all patients regardless of randomized categorization, and this includes: analgesic and nonsteroidal anti-inflammatory drugs (NSAIDs), orthotics with medial stiffness, and reduction of great toe movement in motions such as kneeling or squatting with the toes in an extended position.
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NewsBot · Jul 23, 2008

Phase II Combination Stem Cell Therapy for the Treatment of Severe Leg Ischemia (MESENDO)
Sponsored by: TCA Cellular Therapy

The purpose of this research study is to compare in patients with double-sided claudication if the transplant of a combination of stem cells obtained from the bone marrow of the same patient will contribute to the formation of new blood vessels in one of the severly diseased ischemic limbs(legs)versus the control limb that receives a placebo product.

Limb Ischemia (LI) is a severe obstruction of the arteries which seriously decrease blood flow to the extremities (mainly feet and legs) and has progressed to the point of severe pain and even skin ulcers or sores.

LI needs conprehensive treatment since the condition will not improve on its own. The overall goal of treatment is to reduce pain and increase blood flow to improve symptoms or save the leg and feet. In many cases, current options for treatment including medications, surgery or endovascular procedures have not been successful.

In the last few years, investigators have explored therapies aimed to increase blood flow to the isschemic vessel by transplanting cells that will promote the development of new vessels in the diseased leg.

The study hypothesis is based on the concept that the process of formation of new blood vessels is complex and requires the participation of several types of stem cells and growth factors. The lack of any of these components will produce vessels which are immature and unable to provide appropriated blood supply to the leg.

Patients eligible to participate in the this study are those suffering from double-sided claudication with poor circulation or severe leg blockages, which are not candidates for surgical procudures.

Once the mixture of stem cells is prepared and the patient's bone marrow is ready, cells will be transplanted into the calf muscle of one the the diseased legs while the other diseased leg will recieve the placebo. Clinical study to evaluate and compare the effacacy of the stem cell transplant will be performed for six months post cell transplant.
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Link to study

NewsBot · Jul 30, 2008

This clinical trial has just been registered:
Comparison of Two Methods of Negative Pressure Wound Therapy

The current standard for negative pressure wound therapy is the Vacuum Assisted Closure Device (VAC), a commercial system that utilizes a computerized suction pump to apply negative pressure to an open-cell poly-urethane foam dressing sealed over a wound. The VAC system is effective but has some drawbacks:

The system is expensive.
There us conflicting data about the effectiveness of VAC therapy for infected wounds.
VAC therapy is difficult to use (and frequently fails) in wounds with excess fluid drainage, and in wounds near body orifices.
Over the past 4 years, we have accumulated additional experience with negative pressure wound therapy using wall suction applied to sealed gauze dressings with about 30 patients. We call this method G-SUC and have used it when we have been unable to maintain a dressing seal with the VAC system (due to excess drainage or wound location), for management if infected wounds. We have found this method to be effective without any specific negative side effects.

Our specific aims are:

Compare the effectiveness of G-SUC and standard VAC therapy. Outcomes measured for each method will include the proportional change in wound size over 1 - 2 weeks.
Compare the effectiveness of G-SUC and VAC system in controlling wound infections as measured by the number of patients who are able to clear infection by 4 days.
Compare the failure of each method of therapy by documenting the number of dressing that cannot be maintained because of fluid or suction.
Measure and compare the cost of wound treatment with the two methods including direct cost and time spent at the bed side performing the dressing change.
Our hypotheses are:

G-SUC and VAC are equivalent for the treatment of uncomplicated wounds in the acute care, in-patient setting.
G-SUC is more effective than VAC for management of infected wounds.
G-SUC is more versatile than VAC, and functional G-SUC dressings can be maintained in situations where functional VAC dressings cannot.
Negative pressure therapy with G-SUC is less costly than VAC.
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NewsBot · Aug 8, 2008

Efficacy and Safety Study of 4 Dose Regimens of Oral Albaconazole in Subjects With Distal Subungual Onychomycosis

NewsBot · Aug 11, 2008

Ischemic Foot Ulcers: Is Intervention Better Than Wound Care Alone

This research study will compare two approved standard of care treatment modalities for the management of ischemic foot ulcers. The ischemic foot ulcer (wound) on your foot is a result of a blocked artery in your leg. The wound can sometimes be healed with wound care alone, which includes dressing changes with creams and removing (debriding) the dead tissue. Alternatively, the significant narrowing or blockage in one of the arteries in your leg can be treated with several endovascular treatment techniques including:

angioplasty, also called percutaneous transluminal angioplasty (PTA) and/or
stent placement
atherectomy
The hypothesis of this study is that early endovascular or surgical intervention in subjects with moderate arterial insufficiency and a non-healing foot ulcer results in a higher overall incidence of wound healing in a significantly shorter period of time.
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NewsBot · Aug 13, 2008

The Effect of Anti-Inflammatory Analgesics on Pain Following Hallux Valgus Surgery

Purpose
The effects of NSAIDs and Coxibs on the formation of bone and fracture healing have been a matter of debate since long 1,2.

There is, however, limited data in humans and further prospective randomised studies are warranted. Rueben and Ekman studied in a prospective randomised double blind study the effects of celecoxib, a selective cox-II-inhibitor, on pain and bone healing following spine surgery. They found significant effects on reduction of pain and need for opioid analgesics postoperatively but could see no negative effects the numbers of "none-unions" at a 1-year follow up 3.

In a similar prospective randomised double-blind study design significant effects in reduction of pain and need for rescue analgesia was seen from the use of celecoxib in the perioperative multi-modal pain strategy for cruciate-ligament reconstruction and no negative effects could bee seen on six month follow-up of the strength of the reconstructed ligament 4,5.

The aim of the present study is to further study the effects of the perioperative use of etoricoxibe, a selective cox-II-inhibitor, in a prospective randomised double-blind study on bone healing, pain and need for rescue analgesia in patients undergoing elective Hallux Valgus surgery with a standardised surgical technique ad modum Turan.
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NewsBot · Aug 15, 2008

Hyperpronation and Foot-Pains

Purpose
Effects of training and pellots
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NewsBot · Aug 21, 2008

Impaired Wound Healing in Diabetic Foot Ulceration (EPC)

An observational study to gather information about people who may have certain abnormalities in skin microcirculation and muscle metabolism and to determine whether these abnormalities affect wound healing. The study also examines the association of a specific type of cell with the rate of wound healing.
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An observational study which entails: medical history; physical examination; blood tests; MRI; microcirculation tests (two noninvasive tests: 1) a procedure that measures the resting blood flow of the skin and 2) a technique that introduces acetylcholine and sodium nitroprusside in the skin and measures the ability of the skin's vessels to dilate and increase blood flow); and macrocirculation tests (noninvasive ultrasound of arm
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Admin2 · Sep 10, 2008

Multicenter Study of the Safety and Efficacy of NAFT-500 in Tinea Pedis

A research study to compare the safety and effectiveness of an investigational medication called NAFT-500 to placebo, when used in subjects with tinea pedis (athlete's foot).
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NewsBot · Sep 23, 2008

Bracing and Strengthening for Posterior Tibial Tendon Dysfunction

Posterior tibial tendon dysfunction (PTTD) is a problem with the tendon connecting one of the lower leg muscles to the foot bone. PTTD can cause pain, swelling, and a flattened foot, and may require surgery if left untreated. Normal treatment for PTTD includes physical therapy exercise. In treating similar conditions in the lower leg, exercises that are active, like strengthening, seem to have better results than exercises that are passive, like stretching. This study will determine whether adding strengthening exercises to a normal PTTD treatment that includes wearing a brace and stretching is more beneficial than just wearing a brace and stretching.
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Posterior tibial tendon dysfunction (PTTD) involves inflammation, overstretching, or both of the posterial tibial tendon, which connects the tibialis posterior muscle to the bones in the foot. PTTD can cause pain in the inner ankle and development of a flat foot. Without treatment, correction of PTTD may require surgery. Standard interventions that may prevent the need for surgery include orthotic devices, bracing, and physical therapy, among other possibilities. Within physical therapy, foot exercises can be either active—as in the case of strengthening exercises—or passive—as in the case of stretching exercises. Evidence from clinical treatment of similar conditions suggests that active exercises are more effective than passive exercises in leading to recovery. This study will determine whether adding strengthening exercises to a normal intervention of bracing and stretching is more effective in improving a range of symptoms in stage II PTTD patients than using only bracing and stretching exercises.

Participants with stage II PTTD will be recruited and placed in one of two groups for the duration of the 12-week study. The first group will undergo regular bracing and perform stretching exercises. The second group will undergo regular bracing and perform stretching and strengthening exercises. Braces, worn during weight bearing tasks throughout the study, will include ankle stirrup support and medial longitudinal arch support. Strengthening exercises, which will be preceded by a warm-up of the posterior tibialis muscle, will include bilateral heel raises, foot adduction and rear foot inversion with thera-tubing, and unilateral heel raises. Frequency of exercise and number of repetitions will increase over the course of the study until participants are performing three sets of 30 repetitions two times per day. Assessments, which will occur at study entry, after 6 weeks, and after 12 weeks, will include foot range of motion, length of the posterior tibial muscle, and self-assessments of function.
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NewsBot · Sep 25, 2008

PRP to Treat Plantar Fasciitis

Rationale: The standard treatment of chronic plantar fasciitis is corticosteroid injections. Corticosteroid injection give temporarily pain reduction, but no healing. Blood platelets initiate the natural healing rate. GPS ® gives an eightfold concentrate platelets of patients own blood. Injection of these platelets in the tendon might induce a healing rate.

Objective: To compare the efficacy of autologous platelet concentrate injections with corticosteroid injection in patients suffering from plantar fasciitis with respect to pain and function.
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NewsBot · Sep 25, 2008

Obtaining and Storing Standard of Care Wound Biopsies for Immediate or Future Wound-Related Scientific Study

The objective of this study protocol is to use wound biopsies that have been obtained during standard of care management for further scientific evaluation after standard evaluation by a pathologist. Further imaging and molecular analyses would closely evaluate the presence, architecture, and interaction of wound biofilm and human host tissues.
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The criteria for considering a wound biopsy in a given patient are a chronic wound (venous leg ulcer, diabetic foot ulcer, decubitus ulcer) that has been present for over two (2) months and has failed to progress towards healing (less than 20% decrease in size over 2-week period of time). Also any suspicious wound in which cancer is strongly considered on a clinical basis should be biopsied immediately without any arbitrary timeline being imposed.
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NewsBot · Sep 29, 2008

A Pilot Diabetic Foot Ulcer Study

The objective of this study is to compare the reduction in wound surface areas between patients with diabetic ulcers utilizing Provant's pulsed radio frequency energy therapy (PRFE) as an adjunct to standardized basic wound care to those utilizing standardized basic wound care alone.
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According to the American Diabetes Association (ADA), there are approximately 20.8 million people in the US with diabetes or 7% of the population (1). A significant number of the diabetic population is prone to pedal ulceration and estimates reveal that 15-20% of this population will develop a foot ulcer in their lifetime.

Treatment of diabetic foot ulcerations have posed a problem to healthcare providers for many years. The literature describes many different modalities for direct wound treatment strategies. Most of these treatments rely on the timely application of biological dressings, offloading of the wound, regular (and often inconvenient) visits to the doctor, and most important, compliance by the patient. It is not uncommon for such wounds to be present for greater than six months, despite use of debridement, off-loading and other basic wound care techniques, before presenting for advanced therapy.

Provant has been selected for study because:

It is already indicated for the adjunctive palliative treatment of postoperative pain and edema in superficial soft tissue.
It is a non-invasive wound treatment system which utilizes a proprietary PRFE signal which is hypothesized to trigger the release of endogenous growth factors that induce mitosis through accelerating the cell cycle, using a Ca+2 mediated pathway. The result is a significant increase in the rate of cell replication.
It has also been shown that PRFE triggers a genetic sequence or cascade of 'wound repair' genes critical for the four stages of wound healing: inflammation, granulation, epithelialization, and remodeling.
It has been utilized in the VA Health System since 2004 with no serious adverse events attributable to the device.
This study will assess as an endpoints:

Primary - the incidence of wounds reaching complete closure, and
Secondary - the time to complete wound closure percentage reduction in wound area, percentage reduction in wound volume, and rate of healing mm2/day and mm3/day.
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NewsBot · Sep 30, 2008

The AutoloGel™ Post-Market Surveillance (TAPS) Program

Purpose
AutoloGel™ Post-Market Surveillance Program

Purpose:Evaluate the incidence of hematologic and immunologic adverse events, including coagulopathies in patients with wounds to which AutoloGel™ was applied.

Design:prospective, open label, patient registry. Investigator Sites: 3 Enrollment Size: 300

Subject Population: Patients with exuding wounds, such as leg ulcers, pressure ulcers, and diabetic ulcers and for the management of mechanically or surgically-debrided wounds.

Primary Objective Safety: Assess the incidence of hematologic (coagulopathies), immunologic (including anaphylaxis) and other adverse events associated with the application of AutoloGel on exuding wounds, such as leg ulcers, pressure ulcers and diabetic ulcers and during the management of mechanically or surgically-debrided wounds.

Primary Safety Endpoint: Absence of coagulopathies caused by inhibitors to coagulation Factor V as determined by a significant prolongation of the prothrombin (PT) time and confirmed by severe depletion of Factor V activity with a positive Bethesda Assay for anti-Factor V functional inhibitors
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Study Type: Interventional
Study Design: Other, Open Label, Historical Control, Single Group Assignment, Safety Study

Official Title: The AutoloGel™ Post-Market Surveillance (TAPS) Program

Further study details as provided by Cytomedix:

Primary Outcome Measures:
Assess the incidence of hematological immunologic other ae's assoc with the application of AutoloGel on exuding wounds such as leg ulcers pressure ulcers and diabetics ulcers and during the management of mechchanically or surgically debrided wounds [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
Absence of coagulopathies caused by inhibitors to coagulation Factor V as determ. by a significant prolongation of the (PT) time and confirmed by sever depletion of Factor V activity with a positive Bethesda Assay for anti-Factor V functional inhibitors [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: September 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)

Intervention Details:
Device: AutoloGel System
The AutoloGel™ System may be used for chronic or surgically-debrided wounds up to twice a week for eight (8) weeks. The treating health care practitioner may elect to continue the treatment up to twelve (12) weeks. The AutoloGel™ System should be used in conjunction with standard of care procedures for comprehensive wound management , such as:

Removal of necrotic or infected tissue Off-loading Compression therapy for venous stasis ulcers Establishment of adequate blood circulation Maintenance of a moist wound environment Management of wound infection Wound cleansing Nutritional support, including blood glucose control for subjects
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NewsBot · Sep 30, 2008

Effect of Weight-Bearing Exercise on People With Diabetes and Neuropathic Feet

The purpose of this study is to determine if people with Diabetes Mellitus and peripheral neuropathy can increase their activity (i.e. walking or stationary biking) and leg strength without having an increase in foot problems compared to a group of people with diabetes and peripheral neuropathy that do no exercise.

Our hypothesis is that the weight-bearing exercise group will achieve greater increases in weight-bearing activity (i.e., increased steps/day and cumulative load) and leg strength compared to the non-weight bearing exercise group and the non-exercising control group; and there will be no clinically meaningful difference in incidence or indicators of foot lesions between groups.
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NewsBot · Oct 2, 2008

Safety Study of Topical Doxycycline Gel for Adult Diabetic Lower Extremity Ulcers.

This study is a double-blind, one center, two-arm study with a two (2) week Run-In, evaluating the efficacy of a once-daily administration of NanoDOXTM Hydrogel topically applied to diabetic ulcers in concert with professionally administered Standard of Care (SOC) procedures as described by Standard Operating Procedure(s) of the Department of Veterans Administration Hospitals. Patients with infected wounds will receive oral antibiotic and not included in the topical portion of the study until the infection is shown by wound fluid analysis to be resolved. Following a two (2) week Run-In of all patients to receive SoC treatment for Diabetic Ulcers, patients would have either the investigational material or the placebo hydrogel applied as a part of their wound care. Each patient would receive 1.5gm packets of either the test article or the placebo hydrogel for a once-daily home treatment accompanied by a dressing change.
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NewsBot · Oct 2, 2008

The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients (A6301086)

The primary objective of this 6 month open-label extension trial is to evaluate long-term safety and tolerability of dalteparin in treatment of chronic neuroischaemic foot ulcers in diabetic patients with peripheral arterial occlusive disease (PAOD) and peripheral neuropathy.
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