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Diabetic Foot clinical trials

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NCT ID: NCT02081352 Recruiting - Clinical trials for Diabetic Foot Ulcers

A Comparative Efficacy Study of DermaPureā„¢ to Treat Diabetic Foot Ulcers

Start date: August 2014
Phase: Phase 4
Study type: Interventional

This study has been designed to help determine how safe and effective DermaPureā„¢ may be in treating hard-to-heal diabetic foot ulcers compared to the current standard of care.

NCT ID: NCT02071979 Terminated - Clinical trials for Diabetic Foot Ulcers

Registry Trial of the Effectiveness of Platelet Rich Plasma for Chronic Non-Healing Wounds

CMS
Start date: April 2014
Phase: N/A
Study type: Interventional

This study will examine differences in the process of wound-healing in patients treated with platelet rich plasma (a concentration of proteins derived from a patients own blood) applied to the wound as a gel; injected into the wound or surrounding tissue; or both; compared to patients treated with usual medical treatment . This study seeks to enroll patients who are 18 or older with a non-healing skin wound that is at least 30 days old. Only patients with Diabetic Foot Ulcers, Venous Ulcers, or Pressure Ulcers will be included in the study.

NCT ID: NCT02070835 Completed - Diabetic Foot Ulcer Clinical Trials

Study of Autologous Skin Cell Treating for Diabetic Foot Ulcers

Start date: April 2014
Phase: N/A
Study type: Interventional

Diabetic foot ulcer is one of the refractory wounds and always poses many challenges in clinical practice. This study was conducted to have a prospective, randomised, controlled study compare the safety and efficacy of the autologous skin cell with skin graft (experiment group) with split-thickness skin graft (STSG, control group) alone on treating diabetic foot ulcers.

NCT ID: NCT02055755 Withdrawn - Clinical trials for Diabetic Foot Ulcers

WEMR With Clinical Decision Support for Diabetic Foot Ulcers

Start date: April 2013
Phase:
Study type: Observational

The goal of this project to begin using a wound research database with clinical decision support features at Winthrop University Hospital. A research database is an electronic computer system that is used to collect patient information. Clinical decision support is the ability for a computer system to provide medical assistance to the doctor through alerts and recommendations based on the information entered. The investigators believe that use of a wound clinical decision support tool, much like a drug, will improve healing in patients diagnosed with Diabetic Foot Ulcers and ultimately lower the risk of death and illness caused by these wounds. In order to develop a useful clinical decision support tool, investigators first need to develop a large research database to determine the data points important for wound healing. The investigators will be using the data collected in this study for future research and publication. Data will be reviewed to answer questions important to diabetic foot ulcer healing and for the purpose of developing the clinical decision support alert system. After providing informed consent, participants will be asked a series of questions related to their past medical history, and relevant wound data will be collected. Study staff will photograph the wound at baseline, and once per week until the wound is completely healed, or for a duration of six months. Participants will be expected to return to Winthrop University Hospital for wound follow-up on a regular basis, or as determined by the Principal Investigator.

NCT ID: NCT02052817 Recruiting - Diabetic Foot Clinical Trials

Randomized, Prospective Evaluation of the Toad Brace in Plantar Ulcer Off-loading and Healing

Start date: December 2013
Phase: N/A
Study type: Interventional

The TOAD Medical Corporation Brace is a novel device that completely off-loads the foot and has been shown to heal ulcers at a rapid rate in preliminary experience in patients with plantar ulcers. This trial will attempt to show the efficacy of the Toad Brace and is based on the hypothesis that the Toad brace completely offloads the foot and hastens healing rates of diabetic ulcers. The trial will randomize 74 patients with diabetic pedal ulcers to the Toad Brace or conventional therapy. . Quantitative assessment of ulcer rate healing rates will be determined clinically and by blinded, computer-assisted planimetry of digital images over a 12 week period. The pressure on the plantar surface will be measured via a pressure sensor in a subset of patients. The trials will attempt to show markedly reduced pressure on the plantar surface and significantly higher ulcer healing rates with using the Toad Brace.

NCT ID: NCT02036528 Terminated - Clinical trials for Diabetic Foot Ulcers

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

Start date: January 2014
Phase: Phase 1/Phase 2
Study type: Interventional

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.

NCT ID: NCT02026830 Completed - Infection Clinical Trials

The Microbiologic Profile of Diabetic Foot Infections in Turkey - TURK-DAY

TURK-DAY
Start date: January 2014
Phase: N/A
Study type: Observational

To determine the causative microorganisms and their antibiotic sensitivity patterns in diabetic patients with a foot infection in Turkey.

NCT ID: NCT02019082 Completed - Diabetic Foot Ulcer Clinical Trials

Electrical Stimulation and Expression of VEGF and NO in Diabetic Foot Ulcer

Start date: March 2011
Phase: N/A
Study type: Interventional

This study aimed to investigate the effect of low intensity cathodal direct current on the release of plasma vascular endothelial growth factor (VEGF) and nitric oxide (NO) in diabetic foot ulceration.

NCT ID: NCT02015910 Terminated - Type II Diabetes Clinical Trials

Januvia (Sitagliptin) in Healing Chronic Diabetic Foot Ulcers

Start date: January 2014
Phase: Phase 4
Study type: Interventional

The primary objective of this study is to compare the rate of healing as well as percent of wounds healed in Type II diabetic patients with chronic foot ulcerations receiving sitagliptin versus placebo. The hypothesis for this study is that subjects receiving daily doses of sitagliptin in combination with their regular antihyperglycemic medications will result in increased healing rates as well as a greater number of healed wounds as compared to subjects receiving placebo and their regular antihyperglycemic medications.

NCT ID: NCT01996995 Completed - Onychomycosis Clinical Trials

Laser Therapy for Onychomycosis in Patients Wih Diabetes at Risk for Diabetic Foot Complications

LASER-1
Start date: March 2015
Phase: N/A
Study type: Interventional

In a sham controlled double-blind trial we aim to establish the efficacy and safety of local application of laser therapy in patients with diabetes with onychomycosis and risk factors for diabetes related foot complications. Onychomycosis leads to thickened and distorted nails, which in turn leads to increased local pressure. The combination of onychomycosis and neuropathy or peripheral arterial disease (PAD) increases the risk of developing diabetes related foot complications. Usual care for high-risk patients with diabetes and onychomycosis is completely symptomatic with frequent skiving and clipping of the nails. No effective curative local therapies exist and systemic agents are often withheld due to concerns for side effects and interactions. Aim: The primary aim is to evaluate the efficacy of 4 sessions N-YAG 1064nM laser application on the one-year clinical and microbiological cure rate in a randomised, double-blinded sham-controlled design with blinded outcome assessment. Study population: Patients with diabetes mellitus, with an increased risk for diabetic foot ulcers. Intervention: local laser treatment from a podiatrist and the other group receives treatment according to a control procedure. The laser 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.