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Diabetic Foot Ulcers clinical trials

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NCT ID: NCT01964521 Completed - Clinical trials for Diabetic Foot Ulcers

TITLE: An Open, Non-comparative, Multi-centre Post Marketing Clinical Follow-up (PMCF) Investigation to Evaluate Performance and Safety on Diabetic Foot Ulcer, DFU, When Using Mepilex Transfer Ag as Intended

MxT Ag 05
Start date: February 2014
Phase: N/A
Study type: Interventional

An open, non-comparative, multi-centre post marketing clinical follow-up, PMCF, investigation to evaluate performance and safety on diabetic foot ulcer, dfu, when using mepilex transfer Ag as intended.

NCT ID: NCT01849965 Terminated - Clinical trials for Diabetic Foot Ulcers

Phase 3 Study Evaluating Efficacy and Safety of DSC127 Compared With Vehicle and With Standard-of-care in Diabetic Foot Ulcers

STRIDE 2
Start date: April 2013
Phase: Phase 3
Study type: Interventional

To determine if aclerastide (DSC127) is effective in increasing incidence of complete wound closure up to 10 weeks confirmed 2 weeks later, compared with vehicle (gel without active ingredient) and compared with a standard-of-care gel, in subjects with diabetes mellitus (DM) who have chronic Wagner Grade 1 or 2 diabetic foot ulcers, 0.75 - 6cm2 in size.

NCT ID: NCT01830348 Terminated - Clinical trials for Diabetic Foot Ulcers

Phase III Study to Evaluate Efficacy and Safety of DSC127 in Diabetic Foot Ulcers

STRIDE 1
Start date: February 2013
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine if DSC127 is effective in increasing incidence of complete wound closure at 10 weeks confirmed at a visit 2 weeks later when compared to the vehicle (gel without active ingredient) in subjects with diabetes mellitus (DM) who have chronic Wagner Grade 1 or 2 plantar neuropathic foot ulcers, 0.75 - 6 cm2 in size.

NCT ID: NCT01824407 Recruiting - Clinical trials for Diabetic Foot Ulcers

A Comparison of the dermaPACE® (Pulsed Acoustic Cellular Expression) Device in Conjunction With Standard of Care Versus Standard of Care Alone in the Treatment of Diabetic Foot Ulcers

Start date: March 2013
Phase: Phase 3
Study type: Interventional

The Sponsor of this study, SANUWAVE, Inc., has developed an investigational device known as the dermaPACE® (Pulsed Acoustic Cellular Expression) device for the possible treatment of diabetic foot ulcers. This device generates acoustic (sound) pressure waves designed to act on the cells in your body to generate proteins that may lead to wound closure. The dermaPACE® device has not been approved for the treatment of diabetic foot ulcers; therefore its use in this study is investigational. The purpose of the study is to evaluate the ability of the dermaPACE® device to help diabetic foot ulcers heal more quickly. The active study device, the dermaPACE®, will be compared to an inactive look-alike device (called a "Sham") in this study. The sham device will not provide any treatment to your diabetic foot ulcer.

NCT ID: NCT01816633 Terminated - Clinical trials for Diabetic Foot Ulcers

Effectiveness of AutoloGel Therapy in Diabetic Foot Ulcers

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

The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, case-matched cohort trial in which diabetic foot ulcers (DFU) will be treated using AutoloGel and case-matched against a concurrent cohort of patients receiving undefined Usual and Customary Care (UCC) as provided in up to 30 U.S. Wound Registry Research Network (USWRRN) centers.

NCT ID: NCT01681160 Completed - Clinical trials for DIABETIC FOOT ULCERS

Study of Maggot Therapy in Diabetic Foot Ulcers

MDT
Start date: January 2009
Phase: N/A
Study type: Interventional

This study was a Kind of clinical trial with equal randomization, that have been done from January 2009 to June 2011 in the AFZALIPOOR hospital endocrine ward in Kerman-Iran on 128 diabetic patient who had foot wounds.Replacement of conventional therapy by new methodes is one of the more important aims for health professional specially for nurses.One of this new treatment is maggot therapy.

NCT ID: NCT01651845 Active, not recruiting - Wounds Clinical Trials

Evaluation of a 'Hand-held' Fluorescence Digital Imaging Device for Real-Time Advanced Wound Care Monitoring (JDRTC/UHN)

JDRTC/UHN
Start date: July 2012
Phase: N/A
Study type: Observational

We have developed an innovative optical molecular imaging platform (called PRODIGI) based on high-resolution fluorescence and white-light technologies in a hand-held, real-time, high-resolution, non-invasive format. PRODIGI offers a non-contact means of obtaining instantaneous image-based measurements of diagnostically-relevant biological and molecular information of a wound and surrounding skin tissues for the first time and could have significant impact on improving conventional wound care, management, and guidance of intervention. The investigators hypothesize that real-time imaging of tissue autofluorescence signals emanating from endogenous connective tissue (e.g. collagen) and pathogenic bacteria within complex wounds can be used to determine healing status (i.e., collagen re-modeling and wound closure), detect wound bacterial contamination and/or infection that is occult under standard clinical white light evaluation, and guide intervention during wound care.

NCT ID: NCT01596920 Completed - Clinical trials for Diabetic Foot Ulcers

Grafix® DFU: Open-Label Extension Option to Evaluate Safety & Efficacy of Grafix® for Chronic Diabetic Foot Ulcers

DFU
Start date: April 2012
Phase: Phase 4
Study type: Interventional

The primary objective of the present study is to further establish in a randomized controlled trial, the safety and efficacy of weekly Grafix® administration versus control in patients with chronic diabetic foot ulcers. The primary endpoint is complete wound closure of the index wound, defined as 100% re-epithelialization as determined by the Investigator. Grafix® is a product regulated for use in the US by the FDA as a Human Cellular and Tissue Based Product (HCT/P) under Title 21 CFR Part 1271.

NCT ID: NCT01537016 Recruiting - Clinical trials for Diabetic Foot Ulcers

WOUNDCHEK™ Protease Status Point of Care (POC) Diagnostic Test on DFU

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

The purpose of this trial is to determine if wounds with elevated protease activity (EPA) treated with targeted interventions such as protease modulating therapies can improve clinical and economic outcomes. It is hypothesized that protease modulating dressings may provide significantly better clinical outcomes on EPA wounds over current standard of care.

NCT ID: NCT01490879 Completed - Clinical trials for Diabetic Foot Ulcers

A Study to Investigate the Safety and Clinical Effect of Nexagon® as a Topical Treatment for Subjects With a Diabetic Foot Ulcer (DUNE)

DUNE
Start date: July 2012
Phase: Phase 2
Study type: Interventional

This study is for Type I or Type II diabetic subjects with with a diabetic foot ulcer. The study is being done to determine if Nexagon® plus standard of care is more effective than placebo plus standard of care. Standard of care will include debridement of the ulcer, standardized dressings and standardized off-loading using a Removable Cast Walker.