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Foot Ulcer clinical trials

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NCT ID: NCT01614379 Withdrawn - Clinical trials for Diabetes Mellitus, Type 1

Non-enhanced Magnetic Resonance Angiography of Diabetic Ischemic Lower Limbs

Start date: June 2012
Phase: N/A
Study type: Observational

Diabetic foot ulcers often progresses after many years of diabetes where the patients system is so damaged that normal heeling of ulcers cannot happen. The physician at the clinic examines the foot, measuring its circulation and sensitivity. The measures are the blood pressure in comparison between foot and upper arm and oxygen level in the foot. The measurements have a direct connection to the blood circulation, but it doesn't visualize the blood circulation. Development of MR methods without the use of contrast agents have become so good that images of the blood veins can be used in treatment. This means that the MR images provide important information about the patient vessel wall stiffness and blood circulation without the use of the damaging substances. Hence the physician can perform the MR examination and in comparison with the test performed at the clinic he can make an improved and without risk diagnose. Using MR at a lot earlier stage in the treatment is expected to reduce the number of amputations. This is not only an economic advantage, but also an improvement of the patient quality of life. The objective of the study is to investigate type 1 diabetics oxygen level, vessel wall stiffness, blood circulation, tissue contribution and blood pressure in the foot with the use of conventional measurements in their treatment and with the added use of MR methods. This will provide the physician with valuable information of the patient illness and is expected to play an important role in the prevention of diabetic foot ulcers. We expect that MR research leads to a much improved prevention and treatment of aggressive and destructive diabetic foot ulcers. This will increase the general quality of life and reduce the large number of amputations performed every year.

NCT ID: NCT01113658 Withdrawn - Clinical trials for Diabetic Foot Ulcers

Clinical Evaluation of the SNaP Wound Care System

Start date: March 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the efficacy of design improvements of the Spiracur SNaP Wound Care System. This study prospectively evaluates the safety and efficacy of current and new design iterations of components of the FDA-cleared Spiracur SNaP Wound Care System in order to optimize safety, efficacy, and system performance.

NCT ID: NCT01105884 Withdrawn - Clinical trials for Diabetic Foot Ulcers

Clinical and Cost Effectiveness of Different Dressing Materials in Diabetic Foot Ulcers

Start date: October 2009
Phase: N/A
Study type: Interventional

The purpose of the study is to evaluate the efficacy and safety of different commonly used dressings for treating diabetic foot ulcers. It is a prospective study recruiting 50 type 2 diabetic patients with diabetic foot ulcers (2-50cm2). All the patients will give written informed consent prior to getting enrolled in the study. All the patients will be randomly assigned to one of the five groups of the study namely, saline (control),Biatin Ag (Foam), Hydrocolloid, Hydrogel and Ceredak. Follow up of the patients will be done until the complete healing of the wound takes place. All procedures of dressing will be done by an authorized and certified Podiatric Surgeon of the Institution. Details on the cost incurred and days required for the wound to completely heal will be recorded for all the patients. This study will provide the efficacy of all the dressings used for treating diabetic foot ulcers and also the cost of each dressing. This will help the surgeons for managing the diabetic foot ulcers in a better and cost effective way, which in turn will reduce the burden of patients both physically and financially.

NCT ID: NCT01068171 Withdrawn - Clinical trials for Diabetic Foot Ulcers

Developing a Diabetic Foot Ulcer Protocol

Start date: May 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to determine which treatment, over 6 months, will promote healing of diabetic foot ulcers that are not infected in the most efficient, cost-effective way.

NCT ID: NCT00954343 Withdrawn - Clinical trials for Chronic Diabetic Foot Ulcers

Shockwave Treatment of Diabetic Foot Ulcer: Step I

STUF
Start date: August 2009
Phase: N/A
Study type: Interventional

Extracorporeal Shock Wave treatment is a well established treatment in orthopedics. Considerable success has been reported after treatment of various soft tissue pathologies (Tendinitis, heel spur etc). In recent years, encouraging results have been reported concerning the effect of the shock-wave on chronic wounds. It has been reported that healing time can be considerably shortened if shock-waves are applied to the wound in addition to conventional wound treatment. Yet, randomized, controlled, prospective trials are missing. In this study, the effect of shock-waves on diabetic foot ulcer shall be assessed. The study is composed of 5 groups of which 4 groups receive shock wave treatments (each with a different protocol). One group serves as an untreated control group. All groups get standardized wound treatment and wound dressing. That shock-wave application protocol that shows the best results (rate of completely healed ulcer, most decrease of ulcer size) shall be tested in a further, sufficiently dimensioned, two-armed, randomized controlled trial (RCT).

NCT ID: NCT00700362 Withdrawn - Diabetes Mellitus Clinical Trials

Insulin Infusion and Infectious Diabetic Foot Ulcers (IIIFU)

Start date: December 2011
Phase:
Study type: Observational

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.

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.