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Foot Ulcer clinical trials

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NCT ID: NCT02506452 Active, not recruiting - Clinical trials for Diabetic Foot Ulcers

Postmarket Study to Evaluate Biovance® in Diabetic Foot Ulcers

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

The purpose of this study is to compare the wound closure outcomes of subjects receiving diabetic foot ulcer treatment with and without the use of Biovance®.

NCT ID: NCT02344329 Active, not recruiting - Diabetes Clinical Trials

A Comparison of TCC-EZ Using Human Amnion Allograft vs TCC-EZ and Standard Wound Care in Treating Diabetic Foot Ulcers.

TAD
Start date: August 2014
Phase: Phase 4
Study type: Interventional

A Comparison of AmnioExcel® and Total Contact Casting (TCC-EZ) Versus Standard Wound Care and TCC-EZ in Treating Diabetic Foot Ulcers Best practice is to treat DFUs with standardized care and, if unsuccessful, use advanced modalities. This prospective clinical trial will compare healing rates between two treatment modalities in patients with DFUs in an ambulatory wound care clinic. The treatments are Total Contact Cast (TCC-EZ) with AmnioExcel® and TCC-EZ with standard treatment. Adult participants 18 years or older with a diabetic foot ulcer located on the plantar surface and >1 cm in diameter will be asked by the Altru Wound Care Clinic MD or Family Nurse Practitioner visit to participate in the study if they have not demonstrated a 50% in reduction in wound area after two weeks of standard treatment. For those potential subjects who do not have 3rd party reimbursement the cost of the product and application will be covered by the respective company. They must be cognitively intact as evaluated by wound clinic primary care providers. Participants must agree to use the study treatments as directed, and to keep clinic visits during the 12-week trial or until the ulcer closes, whichever comes first.

NCT ID: NCT02326337 Active, not recruiting - Diabetic Foot Ulcer Clinical Trials

Efficacy, Safety and Economic Benefits of Topical Wound Oxygen Therapy in the Treatment of Chronic Diabetic Foot Ulcers

TWO2DFU
Start date: October 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety and economical benefits of Cyclical Pressure Topical Wound Oxygen (TWO2) Therapy in the treatment of chronic diabetic foot ulcers. Subjects will wear a standardized off-loading device and use advanced moist wound therapy (AMWT) dressings. Following a 2 week run-in period with the standardized care and after meeting all the eligibility criteria, half the subjects will use the TWO2 device, while the other half will use a sham device.

NCT ID: NCT01710774 Active, not recruiting - Diabetic Foot Clinical Trials

Telemedicine Follow-up in Primary Health Care for Diabetes-related Foot Ulcers

DiaFOTo
Start date: April 2012
Phase: N/A
Study type: Interventional

This study will investigate whether telemedicine follow-up care for people with diabetes-related foot ulcers and people with leg ulcers (without diabetes) in municipal primary health care in collaboration with specialist health care is an equivalent alternative to traditional outpatient clinical follow-up in specialist health care (noninferiority trial) in relation to healing time.

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: NCT01472432 Active, not recruiting - Chronic Foot Ulcers Clinical Trials

DPP IV Inhibition Facilitates Healing of Chronic Foot Ulcers in Type 2 Diabetes

Start date: May 2011
Phase: Phase 4
Study type: Interventional

A randomized versus placebo trial designed to evaluate the clinical and humoral effects of 4 months of vildagliptin on healing of chronic ulcers in type 2 diabetes.

NCT ID: NCT00926068 Active, not recruiting - Diabetic Foot Ulcer Clinical Trials

Safety and Efficacy of HO/03/03 10μg in the Treatment of Plantar Neuropathic Diabetic Foot Ulcers

Truheal
Start date: February 2010
Phase: Phase 2
Study type: Interventional

A prospective, double blind, randomized, placebo controlled, outpatient, parallel group comparison trial to assess the safety and efficacy of HO/03/03 10µg versus Placebo, applied topically once daily for up to 14 weeks in at least 196 subjects diagnosed with Diabetes Mellitus and having a single target non-healing Plantar Neuropathic Diabetic Foot Ulcer.

NCT ID: NCT00521937 Active, not recruiting - Diabetes Clinical Trials

Efficacy and Safety Study of DERMAGEN® vs Conventional Treatment to Treat Diabetic Neuropathic Foot Ulcer

DERMAGEN®
Start date: January 2009
Phase: Phase 3
Study type: Interventional

It is estimated that 300 million people worldwide will have diabetes by the year 2025. About 12 percent of those with diabetes will have had a foot ulcer, which is a major source of morbidity, concern, and cost. The foot ulcers are the leading cause of hospitalization among people with diabetes and often lead to amputation. The costs of treatment and the high morbidity and mortality associated with diabetic foot problems necessitate the need for a systemic approach to a foot ulcer management. Current local treatments of this type of ulcer are: dressings (hydrocolloids, alginate…), and growth factors. However modern dressings may not avoid infection and the results of the clinical studies are not significant in terms of complete healing rate or in terms of time to healing. Concerning growth factors, the only one whose therapeutic application made proof is the rhPDGF (Regranex®) with an increase in the number of ulcers completely healed at the twentieth week compared to placebo (50% and 35%, respectively). The advancement of tissue-engineering has made possible dermal replacement on human wounds to facilitate healing. A new sponge composed of collagen and glycosaminoglycans (chondroitins 4 and 6 sulphate), reticulated by ionic bonds with chitosan before freeze-drying, was developed in France. This sponge is a non-toxic product due to its non-chemical reticulation (ionic bonds), biocompatible and biodegradable processes, handling and storable easily. The objective of this study is to demonstrate that such a substitute, cellularized by functional allogenic fibroblasts, and complying with all safety conditions, enables to lead to healing of diabetic foot ulcers.

NCT ID: NCT00389636 Active, not recruiting - Diabetic Foot Ulcer Clinical Trials

TheraGauze™ Alone and Regranex®Gel 0.01% Plus TheraGauze™ in the Treatment of Wagner Stage I Diabetic Foot Ulcers

Start date: September 2006
Phase: N/A
Study type: Interventional

Patients will be randomized to receive TheraGauze alone or with Regranex to treat diabetic foot ulcer condition. The purpose of the study is provide the sponsor with pilot information regarding the ability of TheraGauze to promote wound healing on its own and to examine synergy with Regranex in the treatment of diabetic foot ulcers.

NCT ID: NCT00304733 Active, not recruiting - Clinical trials for Neuropathic Foot Ulceration in Individuals With Diabetes

Wound Healing: Total Contact Cast Vs. Custom-Made Temporary Footwear for Patients With Diabetic Foot Ulceration

Start date: August 2001
Phase: N/A
Study type: Interventional

Objective: to compare the effectiveness of irremovable total contact casts and custom made temporary footwear to heal neuropathic foot ulcerations in individuals with diabetes