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Diabetic Foot clinical trials

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NCT ID: NCT02111291 Completed - Clinical trials for Diabetic Foot Ulcers

Santyl Applications to Diabetic Foot Ulcers

Start date: April 2014
Phase: Phase 4
Study type: Interventional

The current trial examines the potential benefits of continuous 12 week treatment with Santyl, measured in terms of wound bed appearance. The visual appearance of granulation tissue will be recorded at each visit for the purpose of examining the relationship between wound bed appearance and progress towards healing. In support of this longer treatment regimen with Santyl, a recent animal study found that application of Santyl for 12 weeks was safe and well tolerated. Therefore, the present study is designed to test the hypothesis that daily treatment of diabetic foot ulcers (DFU) with Santyl for up to 12 weeks will result in more rapid development of granulation tissue than DFU treated with supportive care.

NCT ID: NCT02098447 Completed - Clinical trials for Chronic Diabetic Foot Ulcers

Pilot Study on Auricular Vagus Nerve Stimulation Effects in Chronic Diabetic Wounds

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

The purpose of this pilot study is to evaluate the effect of auricular autonomous nervous system stimulation on vital parameters of wound healing in diabetics. It is investigated if auricular vagal nerve stimulation has an effect on heart rate variability as well as peripheral local blood perfusion, and if this effect depends on the health status of the study participants (diseased/healthy).

NCT ID: NCT02097615 Completed - Clinical trials for Soft Tissue Infections

Diabetic Foot Ulcer. Effectiveness of Chlorhexidine Gluconate 0.125 % Compared With Sterile Deionized Water

Start date: May 2014
Phase: Phase 4
Study type: Interventional

At present research has generated controversy regarding the utility of antiseptics in wound management for diabetic foot ulcers syndrome. However, these studies have been done in tissues and animal models. This study involves the best presently antiseptic for residual effect and low toxicity in an approach to eliminate microorganisms promoters formation of biofilm, contributing to the treatment for accelerated closure the diabetic foot ulcers syndrome . So it is necessary to determine if irrigation ulcer diabetic foot syndrome with chlorhexidine 0.125 % aqueous solution determines the decrease of the surface to a greater extent than the standard treatment using irrigation with sterile deionized water .

NCT ID: NCT02092870 Completed - Diabetic Foot Clinical Trials

Adipose Derived Regenerative Cellular Therapy of Chronic Wounds

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

Our study aims to explore the effects of Adipose Derived Stem Cells (ASCs) on chronic wounds.

NCT ID: NCT02091778 Completed - Clinical trials for Diabetic Foot Ulcers

Open, Non-comparative, Multi-centre Post Marketing Clinical Follow-up Investigation to Evaluate Performance and Safety on Diabetic Foot Ulcer, DFU When Using Fast Gelling Dressing as Intended.

CHEXU 01
Start date: August 2014
Phase: N/A
Study type: Interventional

The primary objective of this post market clinical follow-up (PMCF) investigation is to evaluate performance and safety of fast gelling dressing when used as intended in Diabetic Foot Ulcer (DFU). The primary endpoint will be Changes from baseline in the condition of the peri-wound skin measured by the following variables; maceration, redness/irritation, rash/eczema, blistering, dermatitis, skin stripping, trauma to wound edges and product degradation on the skin

NCT ID: NCT02091596 Completed - Infection Clinical Trials

Topical PluroGel N for the Treatment of Mildly Infected Diabetic Foot Ulcers

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

This will be a randomized, double-blind (evaluator-blind), vehicle-controlled study of 50 enrolled subjects. Adult subjects (greater than 18 years old) who present with a mildly infected diabetic foot ulcer (IDSA criteria) having full thickness (i.e., through the dermis but not involving joint capsule, tendon, and bone). Subjects must also provide informed consent and meet all other entry criteria to be enrolled and randomly assigned to receive PluroGel N or PluroGel vehicle.

NCT ID: NCT02070835 Completed - Diabetic Foot Ulcer Clinical Trials

Study of Autologous Skin Cell Treating for Diabetic Foot Ulcers

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

Diabetic foot ulcer is one of the refractory wounds and always poses many challenges in clinical practice. This study was conducted to have a prospective, randomised, controlled study compare the safety and efficacy of the autologous skin cell with skin graft (experiment group) with split-thickness skin graft (STSG, control group) alone on treating diabetic foot ulcers.

NCT ID: NCT02026830 Completed - Infection Clinical Trials

The Microbiologic Profile of Diabetic Foot Infections in Turkey - TURK-DAY

TURK-DAY
Start date: January 2014
Phase: N/A
Study type: Observational

To determine the causative microorganisms and their antibiotic sensitivity patterns in diabetic patients with a foot infection in Turkey.

NCT ID: NCT02019082 Completed - Diabetic Foot Ulcer Clinical Trials

Electrical Stimulation and Expression of VEGF and NO in Diabetic Foot Ulcer

Start date: March 2011
Phase: N/A
Study type: Interventional

This study aimed to investigate the effect of low intensity cathodal direct current on the release of plasma vascular endothelial growth factor (VEGF) and nitric oxide (NO) in diabetic foot ulceration.

NCT ID: NCT01996995 Completed - Onychomycosis Clinical Trials

Laser Therapy for Onychomycosis in Patients Wih Diabetes at Risk for Diabetic Foot Complications

LASER-1
Start date: March 2015
Phase: N/A
Study type: Interventional

In a sham controlled double-blind trial we aim to establish the efficacy and safety of local application of laser therapy in patients with diabetes with onychomycosis and risk factors for diabetes related foot complications. Onychomycosis leads to thickened and distorted nails, which in turn leads to increased local pressure. The combination of onychomycosis and neuropathy or peripheral arterial disease (PAD) increases the risk of developing diabetes related foot complications. Usual care for high-risk patients with diabetes and onychomycosis is completely symptomatic with frequent skiving and clipping of the nails. No effective curative local therapies exist and systemic agents are often withheld due to concerns for side effects and interactions. Aim: The primary aim is to evaluate the efficacy of 4 sessions N-YAG 1064nM laser application on the one-year clinical and microbiological cure rate in a randomised, double-blinded sham-controlled design with blinded outcome assessment. Study population: Patients with diabetes mellitus, with an increased risk for diabetic foot ulcers. Intervention: local laser treatment from a podiatrist and the other group receives treatment according to a control procedure. The laser procedure will be performed as a sham procedure by a second podiatrist. Main study parameters/endpoints: The effect of 4 sessions of laser therapy on cure rate (clinical and microbiological) after one year.