Diabetic Foot Ulcers

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Diabetic Foot Ulcers

General Purpose:

A number of foot-related complications are possible for individuals with diabetes. Most of the time, diabetic foot complications arise when nerve damage (neuropathy) has occurred as a result of damage from too much blood sugar. This nerve damage leads to a loss of feeling in the feet, which makes it more difficult for diabetic individuals to notice when foot complications or injuries have occurred.

For example, individuals with severe neuropathy might have a cut or scrape on their foot and not notice it for several days. By the time it is observed, it may be seriously infected. The same type of scenario can occur with blisters, foreign objects (such as a tack or piece of glass), or even an injury.

Individuals with diabetes are also more likely to experience extremely dry skin on their feet, which may peel and crack and pave the way for bacteria to enter and cause infection. Calluses are another common problem for diabetics, and can result in the need for therapeutic shoes or sole inserts to cushion the high-pressure areas of the foot. If left untrimmed, calluses can thicken, break down, and turn into ulcers, which are open sores.

Ulcers are the most common foot-related complication experienced by diabetics, and they are also the most dangerous. They are often painless and may not be discovered for some time. If neglected, ulcers can become infected, lead to tissue death, and even require the amputation of a foot or leg.

In fact, individuals with diabetes are more likely than other people to have a foot or leg amputated, due to the fact that many diabetics have artery disease that results in poor blood flow to their lower extremities. When combined with neuropathy, these conditions make it easy to get ulcers and infections that can progress to the point at which amputation is necessary.

A good deal of diabetes-related research is focused on improving the treatment of foot-related complications, as well as discovering new methods of preventing foot complications, minimizing their side effects, and improving prevention-related educational efforts geared toward patients. 

What Will A Diabetic Foot Ulcers Clinical Trial Be Like?

The types of tests and assessments used in clinical trials for diabetic foot complications will ultimately depend on the specific nature of the study and what particular foot complication is being investigated. Provided below is a list of frequent procedures and tests that may be incorporated for use in clinical trials:

  • Physical exam
  • Podiatric (foot) exam
  • Glycated hemoglobin test (A1C test): a blood test that indicates an individual’s average blood sugar level over the prior two months.
  • Random, standard blood sugar tests that measure the amount of glucose in the blood at a particular point in time.
  • Fasting blood sugar tests that measure blood sugar levels following an overnight fast.
  • Oral glucose tolerance tests: this test involves overnight fasting, followed by a fasting blood sugar test, then consumption of a sugary liquid. Blood sugar levels are then tested periodically over the following few hours.
  • Blood tests to monitor cholesterol levels
  • Nerve conduction tests to monitor the health of nerves, especially in the feet.
  • Photographs of ulcers and other wounds to visually document how they are responding to a particular treatment.
  • Blood tests to evaluate the effectiveness or chemical properties of a medication, if you are participating in a clinical trial that is investigating the use of a new drug.
  • Pain and quality of life assessments, as well as food and/or exercise diaries, may also be required in some studies, depending on the research question being studied.

Typical Diabetic Foot Ulcers Clinical Trial Protocol:

Specific examples of clinical trials for diabetic foot complications might include the following:

  • A randomized study in which diabetic patients with a foot ulcer are randomly assigned to receive treatment with a new enzyme-based ointment or standard care over a six week period. During this study, doctors would examine each subject’s foot on a weekly basis to observe the level of healing.
  • A randomized clinical trial in which a new antibacterial cream plus standard wound care is compared to a placebo cream plus standard wound care in diabetic patients with infected foot ulcers.
  • A study to determine if a new drug designed to prevent diabetes-related nerve damage is effective at lowering the incidence of foot ulcers among a sample of diabetic patients who currently have no evidence of foot complications. In this study, a second group of patients would receive a placebo medication rather than the actual new drug for the purposes of comparison.  

A brief word about randomized trials and placebos:

Many clinical trials involve the comparison of an investigational treatment to a “standard” treatment. Some studies determine which therapy a patient receives through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment.

On occasion, a trial will investigate the use of a standard treatment plus a new drug compared to standard treatment plus a placebo (such as the second example listed above). Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.

Placebos are necessary to help determine if adverse effects that occur during the clinical trial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it.

In rare instances where no standard therapy exists, or when a new drug is being evaluated for the first time (such as the third example provided above), the investigational treatment might be compared to a placebo alone. In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.

It is important to know that placebo-only trials are only conducted when scientifically necessary and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment. It is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular disease or condition.

Trial Eligibility and Medical Information Needed:

The type of clinical trial you may be eligible for often depends on many factors, including your history of diabetes, treatment history, and a variety of clinical findings. Therefore, it is important to know many details pertaining to your specific diagnosis when searching for clinical trials. Examples of the details you may want to have on hand include:

  • Your most recent A1C measurement
  • Your prior history of treatment for diabetes, diabetic foot complications, and other medical conditions (including any surgeries, procedures, and medications)
  • Your current medications (including aspirin), vitamins, and dietary supplements
  • Your most recent blood pressure, cholesterol, and triglyceride (i.e., lipid) levels (if known)

Suggested Search Terms:

 “diabetic foot ulcers prevention,” “diabetic foot ulcers treatment,” “diabetic foot ulcers amputation,” “diabetic foot ulcers complications,” “diabetic foot ulcers children,” and “diabetic foot ulcers medication.” For a more broad search, try combining any of the following terms with the phrase “diabetic foot complications”: “children,” “pediatric,” “treatment,” and “prevention.” 

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Study of Subjects With Diabetic Foot Ulcer (DFU)


Condition:   Diabetic Foot Ulcer
Intervention:  
Sponsors:   GlaxoSmithKline;   ICON plc
Not yet recruiting - verified May 2017


DERMALIX Efficacy on Diabetic Foot Ulcers


Conditions:   Diabetic Foot;   Diabetic Foot Ulcer
Interventions:   Other: Standard Dressing;   Device: DERMALIX
Sponsor:   Dermis Pharma
Recruiting - verified April 2017


Evaluation of ABSOLVE in Diabetic Foot Ulcers


Condition:   Diabetic Foot Ulcers
Interventions:   Drug: RhPDGF-BB;   Other: Placebo
Sponsors:   Lynch Biologics LLC;   Medelis Inc.;   Centro Medico Militar
Recruiting - verified January 2017


PriMatrix for the Management of Diabetic Foot Ulcers


Condition:   Diabetic Foot Ulcer
Interventions:   Device: PriMatrix Dermal Repair Scaffold;   Device: Secondary Dressings;   Device: Offloading device
Sponsor:   Integra LifeSciences Corporation
Recruiting - verified March 2017


The Use of Allogenic Platelet Rich Plasma for the Treatment of Diabetic Foot Ulcer


Condition:   Diabetic Foot Ulcer
Interventions:   Biological: Platelet Lysate;   Biological: Platelet Poor Plasma
Sponsor:   Hanan Jafar
Recruiting - verified February 2017


A Feasibility Study of the ReGenerCell™ Autologous Cell Harvesting Device for Diabetic Foot Ulcers


Condition:   Diabetic Foot Ulcer
Intervention:   Device: ReGenerCell™ Autologous Cell Harvesting Device
Sponsor:   Avita Medical
Recruiting - verified December 2016


Passive Training as a Treatment for Diabetic Foot Ulcers


Condition:   Diabetic Foot Ulcers
Intervention:   Device: Passive knee extensor machine
Sponsors:   Herlev Hospital;   University of Copenhagen
Recruiting - verified June 2016


Non-healing Diabetic Foot Ulcers (DFU) Treated With SoC With or Without NEOX®CORD 1K


Condition:   Diabetic Foot Ulcers
Interventions:   Other: NEOX®CORD 1K;   Other: standard of care
Sponsor:   Tissue Tech Inc.
Active, not recruiting - verified February 2017


A Study of Granexin Gel in the Treatment of Diabetic Foot Ulcer


Condition:   Diabetic Foot Ulcers
Interventions:   Drug: Granexin gel;   Other: Vehicle gel
Sponsors:   FirstString Research, Inc.;   INC Research;   Medical University of South Carolina
Recruiting - verified August 2016


A Study of Granexin Gel to Treat Diabetic Foot Ulcer


Condition:   Diabetic Foot Ulcers
Interventions:   Drug: Granexin gel;   Drug: Vehicle gel
Sponsors:   FirstString Research, Inc.;   INC Research;   Medical University of South Carolina
Recruiting - verified August 2016


Safety Study to Examine the Systemic Exposure of Granexin® Gel After Topical Application to Diabetic Foot Ulcers


Condition:   Diabetic Foot Ulcers
Intervention:   Drug: Granexin® gel
Sponsors:   FirstString Research, Inc.;   Medical University of South Carolina;   Spartanburg Regional Healthcare System
Recruiting - verified March 2017


Evaluation of Woulgan in Diabetic Foot Ulcer


Condition:   Diabetic Foot Ulcers
Interventions:   Device: Woulgan Gel;   Device: Intrasite Hydrogel
Sponsor:   Biotec Pharmacon ASA
Recruiting - verified July 2016


dHACM In the Treatment of Diabetic Foot Ulcers


Condition:   Diabetic Foot Ulcers
Intervention:   Other: EpiFix
Sponsor:   MiMedx Group, Inc.
Completed - verified July 2016


Postmarket Study to Evaluate Biovance® in Diabetic Foot Ulcers


Condition:   Diabetic Foot Ulcers
Interventions:   Other: Biovance®;   Other: Standard of Care, Diabetic Foot Ulcers
Sponsor:   Alliqua BioMedical, Inc
Active, not recruiting - verified May 2017


BioimPEDance of Diabetic Foot Ulcers


Condition:   Diabetic Foot Ulcer
Intervention:   Other: Foot ulcer impedance
Sponsors:   University Hospital, Grenoble;   French Alternative Energies and Atomic Energy Commission - Grenoble
Completed - verified May 2017


Effectiveness of Aurix Therapy in Diabetic Foot Ulcers


Condition:   Diabetic Foot Ulcers
Intervention:   Device: Aurix
Sponsor:   Nuo Therapeutics
Recruiting - verified October 2016


LeucoPatch in the Management of Hard-to-heal Diabetic Foot Ulcers


Condition:   Diabetic Foot Ulcer
Interventions:   Device: LeucoPatch;   Other: Usual care
Sponsor:   Nottingham University Hospitals NHS Trust
Recruiting - verified April 2017


Safety Evaluation of the KLOX BioPhotonic System in Diabetic Foot Ulcers


Condition:   Diabetic Foot Ulcers
Intervention:   Device: KLOX BioPhotonic System
Sponsor:   KLOX Technologies Inc.
Completed - verified September 2016


Transcutaneous Raman Spectroscope (TRS) Analyses of Diabetic Foot Ulcers


Condition:   Diabetic Foot Ulcer
Intervention:   Device: TRS
Sponsor:   University of Michigan
Terminated - verified April 2017


WEMR With Clinical Decision Support for Diabetic Foot Ulcers


Condition:   Diabetic Foot Ulcers
Intervention:  
Sponsor:   Winthrop University Hospital
Recruiting - verified September 2016


Efficacy of AutoloGel Therapy to Usual and Customary Care in Wagner gd 1 and 2 Diabetic Foot Ulcers.


Condition:   Diabetic Foot Ulcer
Interventions:   Device: AutoloGel;   Other: Usual and Customary Care
Sponsor:   Cytomedix
Terminated - verified October 2016


Effectiveness of AutoloGel Therapy in Diabetic Foot Ulcers


Condition:   Diabetic Foot Ulcers
Intervention:   Device: AutoloGel
Sponsor:   Cytomedix
Terminated - verified October 2016


A Prospective, Randomized, Double-Blind Multicenter Study Comparing Continuous Diffusion of Oxygen (CDO) Therapy to Standard Moist Wound Therapy (MWT) in the Treatment of Diabetic Foot Ulcers


Condition:   Diabetic Foot Ulcer
Interventions:   Device: CDO electrochemical tissue oxygenation system;   Device: Moist Wound Therapy
Sponsor:   Electrochemical Oxygen Concepts, Inc.
Completed - verified February 2017


A Clinical Study of the Safety and Efficacy of MEBO® Wound Ointment in Subjects With Diabetic Foot Ulcers (Pilot)


Condition:   Diabetic Foot Ulcers
Interventions:   Drug: MEBO Wound Ointment (MEBO);   Procedure: Standard of Care (sterile saline moistened gauze)
Sponsor:   Skingenix, Inc.
Completed - verified January 2017


A Clinical Study of the Safety and Efficacy of MEBO Wound Ointment in Subjects With Diabetic Foot Ulcers


Condition:   Diabetic Foot Ulcers
Interventions:   Drug: MEBO Wound Ointment (MEBO);   Other: Standard of Care
Sponsor:   Skingenix, Inc.
Completed - verified January 2017

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