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Foot Ulcer clinical trials

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NCT ID: NCT00563394 Completed - Clinical trials for Diabetic Foot Ulcers

MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers

Start date: August 1994
Phase: Phase 3
Study type: Interventional

224 adults with diabetic foot ulcers will be randomized to either magainin peptide (MSI-78) or ofloxacin (FLOXIN, Ortho-McNeil Pharmaceutical Corporation) an oral fluoroquinolone antibiotic.

NCT ID: NCT00536744 Completed - Clinical trials for Diabetic Foot Ulcers

Effectiveness of dermaPACE™ Device and Standard Treatment Compared to Standard Treatment Alone for Diabetic Foot Ulcers

Start date: October 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the safety and effectiveness of the dermaPACE Device to sham application, when administered in conjunction with standard treatments used in the treatment of DFUs.

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: NCT00477022 Completed - Diabetic Foot Ulcer Clinical Trials

The Effects of Vacuum-Compression Therapy on the Healing of Diabetic Foot Ulcers

VCT
Start date: February 2006
Phase: N/A
Study type: Interventional

the objective of this study is to evaluate the impact of vacuum-compression effects of Vasotrain on the diabetic foot ulcers using stereological method based on Cavalieri’s principle in diabetic patients.

NCT ID: NCT00475202 Recruiting - Clinical trials for Diabetic Foot Ulcers

Hyperbaric Oxygen Therapy and Angiogenesis in Diabetic Patients With Foot Ulcers

Start date: n/a
Phase: N/A
Study type: Observational

Diabetic foot ulcers are a major cause of morbidity and mortality, accounting for approximately two-thirds of all non-traumatic amputations performed in the United States. The cost of foot ulcers in diabetic patients averages almost $28,000 for the two years after diagnosis of the ulcer. Hyperbaric oxygen (HBO) serves as primary or adjunctive therapy for a diverse range of medical conditions. HBO also has been used as an adjunct to antibiotics, debridement, and revascularization in the therapy of chronic, nonhealing wounds associated with diabetes or non-diabetic vascular insufficiency. The aim of the study is to assess whether hyperoxia induced angiogenesis in diabetic patients with foot ulcers.

NCT ID: NCT00463671 Completed - Clinical trials for Diabetic Foot Ulcers

Hyperbaric Oxygen, Oxidative Stress, NO Bioavailability and Tissue Oxygenation

Start date: December 2003
Phase: N/A
Study type: Interventional

Hyperbaric oxygen therapy (HBOT) increases tissue oxygenation and serves as an adjunct therapy for diabetic wounds. However, some patients have insufficient increase or even paradoxical decrease in tissue O2 due to vasoconstriction. The aim of the present study was to investigate the pathophysiology responsible for the different consequences of HBOT and to evaluate the effect of N-acetylcysteine (NAC) on these changes. Methods: Prospective, randomized, cross-over trial including fifty diabetic patients with non-healing ulcers. All patients had two HBOT (100%oxygen, 2ATA) with NAC at the first or the second evaluation. At the beginning and at the end of each evaluation, ulcer oxygenation and plasma levels of malondialdehyde (MDA), total anti-oxidant status (TAOS) and nitric oxide (NO) were measured. Patients with ulcer oxygenation above 200mmHg, were subjected to complete HBOT protocol.

NCT ID: NCT00448903 Completed - Clinical trials for Foot Ulcer, Diabetic

Clinical Trial to Evaluate the Efficacy and Safety of Sodium Bemiparin for Treatment of Diabetic Foot Ulcers

Start date: March 2007
Phase: Phase 3
Study type: Interventional

Chronic foot ulcers are a common, severe and expensive complication in patients with diabetes and often causes lower-extremity amputation. The aim of this study is to evaluate the effect of bemiparin as treatment of diabetic foot ulcers.

NCT ID: NCT00434538 Terminated - Diabetic Foot Ulcer Clinical Trials

BST-DERMON Versus Standard of Care in the Treatment of Diabetic Foot Ulcers

Start date: February 2007
Phase: Phase 3
Study type: Interventional

This trial is designed to investigate the therapeutic benefits of using BST-DermOn for the wound repair of diabetic neuropathic foot ulcers. The objective of this study is to evaluate the safety and efficacy of BST-DermOn in providing a clinically significant advantage over the standard of care in the repair of diabetic foot ulcers.

NCT ID: NCT00432965 Completed - Clinical trials for Diabetic Foot Ulcers

Randomized, Controlled Multicenter Trial of Vacuum Assisted Closure Therapy™ in Diabetic Foot Ulcers

Start date: May 2002
Phase: N/A
Study type: Interventional

To determine if topical negative pressure therapy delivered by the V.A.C.® device is clinically efficacious and cost effective in the treatment of diabetic foot ulcers. The purpose of this study is to compare the effectiveness of V.A.C.® Therapy to moist wound therapy of diabetic foot ulcers. The primary objective is to determine the effect of V.A.C.® Therapy on the incidence of complete wound closure.

NCT ID: NCT00399425 Terminated - Clinical trials for Foot Ulcer, Diabetic

Efficacy of a Low-Molecular-Weight Heparin (Bemiparin) in the Treatment of Chronic Foot Ulcers in Diabetic Patients

Start date: June 2001
Phase: Phase 2/Phase 3
Study type: Interventional

To assess the efficacy of bemiparin (low molecular weight heparin) for 3 months in the treatment of chronic foot ulcers in diabetic patients.