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Foot Ulcer clinical trials

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NCT ID: NCT01474473 Completed - Diabetes Mellitus Clinical Trials

Efficacy Of CACIPLIQ20 On Diabetic Ulcers In Patients Wearing An Nonremovable, Windowed, Fiberglass Cast Boot

DIAPLIQ
Start date: August 2011
Phase: N/A
Study type: Interventional

CACIPLIQ20 is a nanopolymer engineered to mimic glycosaminoglycans such as heparan sulfates. Glycosaminoglycans are implied 1) in the stabilization of the micro-environment of cells, known as extracellular matrix, by binding to structural proteins, and 2) in the cell communication by protecting growth factors. At the site of a lesion, glycosaminoglycans are degraded, thereby the extracellular matrix is disorganized and the tissue is destroyed. By replacing damaged glycosaminoglycans, CACIPLIQ20 provides a protective function and restores the matrix architecture and the cell communication, a process known as Matrix Therapy. As for now, three non-controlled pilot studies have been carried out on small populations. They have shown a substantial enhancement of chronic wounds state after treatment with CACIPLIQ20. Therefore, the purpose of this new controlled study is to determine whether CACIPLIQ20 can shorten diabetic neuropathic plantar ulcers healing when the off-loading is mandatory. The study's main hypothesis is that CACIPLIQ20 application on a non-healing diabetic plantar ulcer in an off-loading mandatory context would reinitiate the natural process of tissue regeneration and lead to total wound closure faster than following standard 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: NCT01454401 Completed - Clinical trials for Diabetic Foot Ulcers

LeucoPatch™ Study A Multicenter Study on the Effect of LeucoPatch™ in Diabetic Foot Ulcers

Start date: October 2010
Phase: N/A
Study type: Interventional

The LeucoPatch™ study goal is to investigate whether the fully autologous growth factor-containing dressing LeucoPatch™ has a positive effect on healing rates of diabetic foot ulcers. The study seeks to gather data for comparison with previous data from similar wounds (historical controls). By subgrouping of the treated wounds (similar to the historical controls used) an assessment of which of the patient and wound-related factors that might indicate a beneficial effect of LeucoPatch™ is sought.

NCT ID: NCT01450943 Completed - Diabetic Foot Ulcer Clinical Trials

VA MERIT: A Comparative Efficacy Study: Treatment of Non-Healing Diabetic

DOLCE
Start date: October 1, 2011
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to assess the effectiveness of cellular dermal replacement tissue vs. non-viable extracellular matrix (ECM) for the treatment of non-healing diabetic foot ulcers. Our hypothesis is that these devices are of equal efficacy.

NCT ID: NCT01434914 Terminated - Ulcus Cruris Clinical Trials

Study to Evaluate the Efficacy of Octenisept® in Patients With Chronic Wounds

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

This is a randomized, double-blind, placebo-controlled trial with octenisept® or placebo in patients with chronic leg ulcers. The study will be conducted at a single center with a total of 70 patients. Patients will be randomized to either the octenisept® group or to the placebo group.

NCT ID: NCT01427569 Completed - Diabetic Foot Ulcer Clinical Trials

Efficacy Study of IZN-6D4 Gel for the Treatment of Diabetic Foot Ulcers

Start date: March 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if topical application of a hydrogel that contains plant extracts will improve healing of diabetic foot ulcers when compared to treatment with a hydrogel alone.

NCT ID: NCT01418456 Not yet recruiting - Diabetes Clinical Trials

Outcomes of Non-infected Diabetic Foot Ulcers With/Without Antibiotics

KADFUT
Start date: August 2011
Phase: Phase 4
Study type: Interventional

The overall objective is to investigate whether antibiotics in the treatment of clinically clean neuropathic and ischaemic ulcers in diabetic foot patients could reduce the incidence of infection and therefore lead to improved outcomes This is a single centre study in which patients with either type 1 or 2 diabetes mellitus, who consecutively present to the Diabetic Foot Clinic [DFC] with clean neuropathic (NU) or ischaemic (IU) diabetic foot ulcer without clinical signs of infection will be invited to take part and will express their willingness to take part in the study by signing a consent form. - All patients will be treated and followed up in the DFC at King's College Hospital. Patients will be randomised into two groups: an antibiotic group and a control group. - The antibiotic group will receive standard treatment along with antibiotics. - The control group will have standard treatment alone. - Patients from both groups will be reviewed at weekly intervals for a period of 20 weeks. - Patients will be removed from the study if they develop clinical signs of infection or if their ulcer heals prior to 20 weeks but will be followed up via routine practice for eventual outcomes

NCT ID: NCT01408277 Completed - Clinical trials for Diabetic Foot Ulcers

Using Santyl on Diabetic Foot Ulcers

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

Subjects enrolled in this study will either use Santyl daily or follow standard care procedures for up to 6 weeks for their diabetic foot wound. After 6 weeks of treatment, the subjects will continue into the follow-up phase for an additional 6 weeks. Study doctors will look at the wound in the office each week (up to 12 weeks) to see if the wound is healing. Depending on a number of factors at each office visit, the study doctors may also use a procedure called sharp debridement to remove dead skin from the wound. This study will test the hypothesis that daily treatment of diabetic foot wounds with Santyl will result in more rapid healing, healthier wounds, and fewer required sharp debridements over the study period than for diabetic foot wounds treated in other ways.

NCT ID: NCT01396837 Completed - Clinical trials for Neuropathic Diabetic Ulcer - Foot

Safety Trial of the RedDress Wound Care System (RD1) in Management of Texas 1a or 2a Neuropathic Diabetic Foot Ulcers.

Start date: May 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety of the RedDress Wound Care System (RD1) in patients Texas 1a or 2a Neuropathic Diabetic Foot Ulcers.

NCT ID: NCT01389362 Completed - Diabetic Foot Ulcer Clinical Trials

The Healing Effect of a Two-Herb Recipe on Foot Ulcer in Chinese Patients With Type 2 Diabetes

Start date: May 2009
Phase: Phase 2/Phase 3
Study type: Interventional

There is now a global epidemic of diabetes and obesity affecting more than 300 million people worldwide with Asia in the forefront. In Hong Kong, diabetes affects more than 10% of the population. Patients with diabetes have a 12—25% lifetime risk of developing a foot ulcer.The abnormal metabolic milieus of hyperglycemia, hyperlipidemia, hypertension, pro-thrombotic state and chronic inflammation in diabetes causes atherosclerosis.A significant proportion of subjects have underlying peripheral arterial disease and neuropathy. These subjects are at great risk of developing infective foot ulceration secondary to impaired vascular supply, sensory loss and minor trauma.Without prompt and proper medical treatment, these infective ulcers will deteriorate leading to gangrene and limb amputation. In-vitro and in-vivo studies revealed that 5 out of the 12 herbs were effective in promoting fibroblast proliferation and angiogenesis. To minimize potential drug interactions and adverse effects from multiple components in a recipe of Traditional Chinese Medicine (TCM), the investigators have developed a simplified formula from the 12 herbs consisting of only two herbs. In this proof-of-concept study, the investigators hypothesize that the novel recipe of herbal medicine will expedite healing of early foot ulcer by promoting vascularisation and granulation as well as modulating inflammatory response.