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Foot Ulcer clinical trials

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NCT ID: NCT02307448 Terminated - Pressure Ulcer Clinical Trials

Effectiveness of Autologous Platelet Rich Plasma in the Treatment of Chronic Non-Healing Wounds

Start date: August 2015
Phase: N/A
Study type: Interventional

This investigation plans to initiate the healing of chronic wounds by providing a concentrated platelet and growth factor therapy directly to the wound site by topical delivery. This therapy will be derived from autologous platelet rich plasma (PRP), an emerging surgical and wound care treatment. This investigation aims to demonstrate that patients with chronic, non-healing wounds treated with autologous PRP and standard medical care have a reduction in wound volume and improved healing rate that results in patient-centered clinically significant health outcomes as compared to patients treated with standard medical care only.

NCT ID: NCT02264288 Terminated - Clinical trials for Peripheral Arterial Disease

Efficacy and Safety of Intramuscular PDA-002 in Subjects Who Have Diabetic Foot Ulcer With and Without Peripheral Arterial Disease

Start date: October 23, 2014
Phase: Phase 2
Study type: Interventional

The PDA-002-DFU-002 trial is a Phase 2, multicenter, randomized, double blind, placebo controlled, dose range finding study. The study will enroll approximately 133 subjects in four treatment groups. The primary objective of the study is to assess the efficacy and safety of PDA-002 administered intramuscular (IM) in subjects who have DFU with and without PAD. The secondary objective is to explore potential clinical efficacy by assessing changes in vascular parameters such as Ankle-Brachial Index and Toe-Brachial Index (ABI and/or TBI), Transcutaneous oxygen measurements (TcPO2).

NCT ID: NCT02202668 Terminated - Diabetic Foot Ulcer Clinical Trials

Transcutaneous Raman Spectroscope (TRS) Analyses of Diabetic Foot Ulcers

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

The primary translational research objective of the study is to demonstrate feasibility of using the Transcutaneous Raman Spectroscopy technology in a point-of-care environment. This study represents an initial evaluation of the device in a small cohort of human patients with diabetic foot ulcers. We will be evaluating safety, device design and certain human engineering factors associated with point of care use of the TRS. We anticipate the data we collect in this study will form the basis of later medical device studies.

NCT ID: NCT02181621 Terminated - Diabetic Foot Ulcer Clinical Trials

A RCT to Compare the Effects of Two Wound Products on Biofilm Disruption in DFUs

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

This study is a prospective comparative study to determine if an Iodine Gel (Iodosorb◊) is better than standard dressing (Solosite◊ gel) in disruption of biofilm (small microorganism bacteria similar to plaque on teeth) on the wound bed diabetic foot ulcers. ◊ Trademark of Smith & Nephew

NCT ID: NCT02166294 Terminated - Clinical trials for Foot Ulcer, Diabetic

NEOX® CORD 1K vs Standard of Care in Non-healing Diabetic Foot Ulcers

CONDUCT I
Start date: June 2014
Phase: N/A
Study type: Interventional

In this randomized, multi-center, cross-over study, the efficacy and safety of NEOX® CORD 1K will be evaluated in patients suffering from non-healing diabetic foot ulcers. NEOX® CORD 1K is a cryopreserved human Amniotic Membrane and Umbilical Cord (AM/UC) matrix intended for use as a wound covering for dermal ulcers and defects. It is designated as a Human Cell & Tissue Product (HCT/P) by the U.S. FDA.

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: 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: NCT01966380 Terminated - Diabetic Foot Ulcer Clinical Trials

Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia

Start date: September 2013
Phase: Phase 2
Study type: Interventional

The purpose of this reseach study is to determine Mölnlycke Health Care´s Leia dressing performance properties is fulfilled and that the dressing is safe when used on wound types such as pressure ulcer, leg ulcer, and diabetic foot ulcer.

NCT ID: NCT01909908 Terminated - Clinical trials for Foot Ulcer, Diabetic

ECM and Blood Components for Wound Healing

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

The Extracellular Matrix (ECM) and Blood Components for Wound Healing feasibility study is a clinical trial approved by Health Canada to study the safety of extracellular matrix (ECM) and autologous blood products in wound healing.

NCT ID: NCT01858545 Terminated - Clinical trials for Foot Ulcer, Diabetic

A Comparative Efficacy Study: Treatment for Non-healing Diabetic Foot Ulcers

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

The primary objective of this study is to assess the effectiveness of MatriStem devices compared to cellular dermal replacement tissue, for the treatment of non-healing diabetic foot ulcers.