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Diabetic Foot clinical trials

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NCT ID: NCT00338702 Withdrawn - Diabetic Foot Ulcer Clinical Trials

A Randomized, Controlled Trial of Autologous Platelet Gel Treatment in Diabetic Foot Ulcers

Start date: March 2008
Phase: Phase 4
Study type: Interventional

Foot ulcers represent a significant common complication in patients with diabetes. Wound healing is a challenge. Some wounds do not respond to the best practices in wound care. Considerable effort has been directed at therapies to improve the rate of healing. There are a variety of growth factors which have been used to stimulate wound healing. Human platelets are an autologous source of growth factors which probably can stimulate healing. Autologous platelet gel (APG) is prepared by centrifugation of autologous human whole blood. APG is rich in platelet growth factors. This study will investigate the potential improvement in wound healing with this material in diabetic foot ulcers. This study will compare the use of autologous platelet gel ( study group) and standard care ( control group) in the treatment of diabetic plantar forefoot ulcers. This study will also compare the cost and quality of life in the two groups. Objectives of the study: - To determine if topical APG (autologous platelet gel) is beneficial in the treatment of diabetic foot ulcers. - To determine if it will result in a faster rate of wound healing. - To determine if it will improve the quality of life in patients with diabetic foot ulcers.

NCT ID: NCT00330265 Recruiting - Diabetes Clinical Trials

Safety and Efficacy Study of an Interactive Wound Dressing (KC002) for the Treatment of Diabetic Foot Ulcers

KC-002PT
Start date: January 2006
Phase: Phase 2
Study type: Interventional

The objective of this study is to determine the safety and effectiveness of a device (the KC-002 interactive wound dressing) in the promotion of healing in diabetic foot ulcers as compared with a conventional wound therapy regimen for subjects with Type 1 or Type 2 diabetes mellitus. This is a prospective, randomized, multi-center, unmasked, controlled study. All patients will receive care for the diabetic foot ulcer during the study. Participation in the study is for 24 weeks.

NCT ID: NCT00318214 Terminated - Clinical trials for Diabetes Complications

Safety and Efficacy Study of MRE0094 to Treat Large, Single or Multiple, Chronic, Neuropathic, Diabetic Foot Ulcers

Start date: June 2006
Phase: Phase 2
Study type: Interventional

This is a clinical research study of an experimental topical drug for the treatment of chronic, neuropathic, diabetic foot ulcers. The purpose of the study is to determine the safety of the experimental drug when applied to large, diabetic foot ulcers. The study will also determine if the experimental drug can safely promote healing of diabetic foot ulcers better than standard treatments currently available to doctors. Patients participating in the study may receive an active drug (MRE0094) or inactive drug (placebo). What treatment a patient will receive is determined by chance (like drawing a number from a hat). All patients will receive additional care for diabetic foot ulcers during the study. Participation in the study can be up to 4½ months.

NCT ID: NCT00316537 Terminated - Clinical trials for Diabetic Foot Ulcers

Safety and Preliminary Efficacy Study of Nicotine Gel to Treat Diabetic Foot Ulcers

Start date: October 2006
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and preliminary efficacy of low dose nicotine gel in patients with chronic diabetic ulcers

NCT ID: NCT00312364 Completed - Clinical trials for Diabetes Complications

Safety and Efficacy Study of MRE0094 to Treat Chronic, Neuropathic, Diabetic Foot Ulcers

Start date: December 2005
Phase: Phase 2
Study type: Interventional

This is a clinical research study of an experimental topical drug for the treatment of chronic, neuropathic, diabetic foot ulcers. Patients participating in the study may receive an active drug (MRE0094), inactive drug (placebo), or a gel used to treat diabetic foot ulcers currently available for sale in the United States. What treatment a patient will receive is determined by chance (like drawing a number from a hat). All patients will receive additional care for diabetic foot ulcers during the study. Participation in the study can be up to 4½ months.

NCT ID: NCT00304733 Active, not recruiting - Clinical trials for Neuropathic Foot Ulceration in Individuals With Diabetes

Wound Healing: Total Contact Cast Vs. Custom-Made Temporary Footwear for Patients With Diabetic Foot Ulceration

Start date: August 2001
Phase: N/A
Study type: Interventional

Objective: to compare the effectiveness of irremovable total contact casts and custom made temporary footwear to heal neuropathic foot ulcerations in individuals with diabetes

NCT ID: NCT00292357 Recruiting - Diabetic Foot Clinical Trials

Local Application of Autologous Bone Marrow Cells for Treatment of Chronic Diabetic Ulcers

Start date: n/a
Phase: Phase 1
Study type: Interventional

Bone marrow cells were previously shown to enhance wound healing in experimental diabetes. In this pilot study, patients with chronic diabetic ulcers not healing under conventional therapy, will be treated with local application of autologous bone marrow cells.

NCT ID: NCT00289497 Completed - Diabetes Clinical Trials

TempTouch IR Thermometry & Diabetic Patient Self-Care

Start date: June 2000
Phase: Phase 2/Phase 3
Study type: Interventional

Foot ulcers develop in diabetics with neuropathy because of cumulative injury over the course of several days. These patients do not feel pain, and do not recognize their foot is being injured until a wound develops. Areas about to ulcerate become inflamed and “hot spots” can be identified. This study’s purpose is to evaluate the effectiveness of a home infrared temperature probe designed to forewarn patients that an area on the foot is inflamed so they can take preventive measures. The study will evaluate the incidence of diabetic foot ulcers among high-risk patients, evaluate the cost of home temperature monitoring compared to standard therapy, and evaluate patient satisfaction. 180 diabetics at high-risk of having foot complications will be randomized into 3 treatment arms: 1) standard therapy consisting of regular foot care; 2) standard therapy plus recording of a structured foot evaluation using a hand mirror; and 3) standard therapy plus infrared home temperature assessment to identify “hot spots.” Device patients will measure temperatures at 6 sites on the foot each day. When temperatures are elevated >4°F patients will contact the research nurse and decrease activity. The primary study outcome will be incident foot ulcers and Charcot fractures.

NCT ID: NCT00235196 Completed - Foot Ulcer Clinical Trials

Evaluation of the Clinical Effectiveness of a Collagen-ORC Antimicrobial Matrix in Full-Thickness, Neuropathic Diabetic Foot Ulcers

Start date: July 2004
Phase: Phase 4
Study type: Interventional

This is a randomized (1:1), prospective, open label, multicenter, comparative study to be examine the effectiveness of Collagen-ORC Antimicrobial matrix, a new wound dressing, on diabetic foot ulcers.

NCT ID: NCT00229112 Completed - Clinical trials for Foot Infections in Diabetic Patients

Comparative Study of Ertapenem Versus Another Antibiotic in the Treatment of Diabetic Foot Infections in Adults (0826-034)

Start date: April 2001
Phase: Phase 3
Study type: Interventional

This study will compare the efficacy, safety and tolerability of intravenous ertapenem versus another intravenous antibiotic in the treatment of moderate to severe diabetic foot infections.