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Diabetic Foot clinical trials

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NCT ID: NCT02248077 Withdrawn - Clinical trials for Impaired Wound Healing

A Prospective, Randomized, Controlled, Multi-Center, Study Evaluating AutoloGel Therapy for Complete Closure of Wagner Grade 1-4 Diabetic Foot Ulcers, Venous Leg Ulcers and Stage II-IV Pressure Ulcers

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

This study is designed to demonstrate the outcome of complete ulcer closure of patients with Wagner Grade 1-4 DFUs, VLUs or Stage II-IV PUs using AutoloGel versus Usual and Customary Care (UCC).

NCT ID: NCT02120755 Withdrawn - Clinical trials for Diabetic Foot Ulcers

A Randomized Comparison of AmnioClearâ„¢ Human Allograft Amniotic Membrane vs. Moist Wound Dressing in the Treatment of Diabetic Wounds

Start date: n/a
Phase: Phase 4
Study type: Interventional

This research project is testing a product called AmnioClearâ„¢ which is an amniotic membrane graft processed for Liventa Bioscience formerly AFCell Medical. AmnioClearâ„¢ allograft human amniotic membrane is regulated solely under section 361 of the Public Health Service Act. The purpose of the study is to see if this treatment works to accelerate the healing time of chronic wounds.

NCT ID: NCT02055755 Withdrawn - Clinical trials for Diabetic Foot Ulcers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: NCT01623882 Withdrawn - Diabetic Foot Ulcer Clinical Trials

Clinical Evaluation of the Combined Use of Apligraf® and the SNaP® Pressure Wound Therapy System

OG/SNaP
Start date: June 2012
Phase:
Study type: Observational

The primary purpose of this study is to evaluate the safety and efficacy of the concurrent use of Apligraf® and the SNaP® Wound Care System for the treatment of diabetic and venous stasis lower extremity ulcers.

NCT ID: NCT01353937 Withdrawn - Diabetic Ulcer Clinical Trials

Endogenous Progenitors Cell Therapy for Diabetic Foot Ulcers

AMD3100
Start date: April 2014
Phase: Phase 1
Study type: Interventional

Diabetic foot ulcers, a complication of diabetes leading to 80.000 lower limb amputations annually in the US, are a significant burden to our health system, costing more than a billion dollars annually. Here, we propose a novel combination of two drugs (Mozobil® and Regranex®Gel) to mobilize a specific sub-type of stem cells (endothelial progenitor cells) from the bone marrow and traffic them toward the wound, increasing the blood supply that subsequently improves wound healing. Because we are using the human body's own resources to regenerate itself by targeting and correcting the underlying pathophysiology, we believe that this novel therapy yields great promise in the treatment of diabetic foot ulcers.

NCT ID: NCT01228500 Withdrawn - Clinical trials for Foot Ulcer, Diabetic

The Use of Bioscaffolds in Conjunction With Negative Pressure Therapy: A Prospective Randomized Double-Blinded Trial

Start date: January 2008
Phase: N/A
Study type: Interventional

The primary aim of this study proposal is to test an innovative form of fetal bovine dermis bioscaffold in combination with negative pressure wound therapy (NPWT) to enhance wound healing in diabetic foot ulcers.

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).