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Foot Ulcer clinical trials

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NCT ID: NCT01870934 Recruiting - Diabetes Mellitus Clinical Trials

3D Camera - Telemedical Foot Ulcer Treatment

Start date: January 2013
Phase: N/A
Study type: Observational

Diabetic foot ulcers are deep wounds that occur as a result of nerve damage in the feet (peripheral neuropathy). Amputation is a common consequence of diabetic foot ulcers; approximately 85% of all diabetes-related amputations are caused by foot ulcers. The ulcer treatment is extensive, resource demanding and highly specialized and necessitates involvement of patient, hospital and local in-home care personnel. The 3D photo optic camera project aims at a much more efficient and precise method for diagnosis and treatment of foot ulcers. The Department of Endocrinology and the section for LEAN and Innovation at Odense University Hospital has developed a prototype for a 3D camera that takes pictures and measurements of the ulcer that can provide the basis for correct diagnosis and treatment of the ulcer. The camera was developed in close cooperation with TECCLUSTER A/S, Svendborg Municipality, Team Online and ComMed.

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.

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: NCT01844479 Completed - Diabetic Foot Ulcer Clinical Trials

Multi-layer Insoles for a Patient-specific Approach to Shear and Pressure Reduction in Diabetes-related Foot Ulcer

Start date: December 2012
Phase: N/A
Study type: Interventional

In this pilot study, the first objective is to bench test a novel shear reducing insole and compare it to current standard insoles and shoes. The second objective is to study twenty-seven insensate diabetes patients with pre-ulcerative foot callus to examine for changes in spatial temporal gait including gait initiation, risk of falling, static and dynamic balance, and plantar temperature response to walking and consecutive plantar stress in both footwear conditions.

NCT ID: NCT01840085 Terminated - Diabetic Foot Ulcer Clinical Trials

Open-Label Study in Diabetic Foot Ulcers (DFU), to Evaluate Safety of 0.03% DSC127 Topical Gel in Chronic Use

STRIDE 5
Start date: December 2015
Phase: Phase 3
Study type: Interventional

To evaluate the safety of topical 0.03% DSC127 Gel when used for one or more continuous treatment periods on a chronic Wagner Grade 1 or 2 foot ulcer(target ulcer) or multiple ulcers in diabetic subjects. The maximum duration of any treatment period is 24 weeks.

NCT ID: NCT01835379 Completed - Diabetic Foot Ulcer Clinical Trials

Study of Oasis Ultra in Diabetic Foot Ulcers

Start date: May 2013
Phase: Phase 4
Study type: Interventional

Many people with diabetes will develop a non-healing diabetic foot ulcer. Many ways are available to try to get a diabetic foot ulcer to heal, including application of Oasis Ultra. The hypothesis to be tested is that application of Oasis Ultra will cause more diabetic foot ulcers to heal than wounds treated with regular medical care. Subjects will have their diabetic foot wounds treated for up to 12 weeks with Oasis Ultra or regular medical care .

NCT ID: NCT01831804 Completed - Wound Healing Clinical Trials

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single and Repeated Doses of Topical GSK1278863

Start date: June 17, 2013
Phase: Phase 1
Study type: Interventional

This is a randomized, placebo-controlled, single-blind (subjects and investigators will be blinded, GSK internal personnel will not be blinded), parallel-group, two part (Part A, Part B) trial in healthy volunteers and subjects with diabetic foot ulcers. Part A is designed to evaluate single applications of GSK1278863 in one cohort of healthy volunteers (intact skin) and approximately 3 cohorts of diabetic subjects. Part B is designed to evaluate first single, and then repeat applications of GSK1278863 in diabetics, both in the clinic and by subjects at home. Part B will include approximately 3 cohorts in which the concentration of drug applied will be determined by pharmacokinetic data from Part A and earlier cohorts in Part B.

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: NCT01816672 Terminated - Diabetic Foot Ulcer Clinical Trials

Efficacy of AutoloGel Therapy to Usual and Customary Care in Wagner gd 1 and 2 Diabetic Foot Ulcers.

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

The purpose of this study is to determine if AutoloGel platelet rich plasma used on non healing diabetic foot ulcers Wagner gd. 1 and 2 is more effective then the usual and customary care