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Diabetic Foot clinical trials

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NCT ID: NCT02120755 Withdrawn - Clinical trials for Diabetic Foot Ulcers

A Randomized Comparison of AmnioClearâ„¢ Human Allograft Amniotic Membrane vs. Moist Wound Dressing in the Treatment of Diabetic Wounds

Start date: n/a
Phase: Phase 4
Study type: Interventional

This research project is testing a product called AmnioClearâ„¢ which is an amniotic membrane graft processed for Liventa Bioscience formerly AFCell Medical. AmnioClearâ„¢ allograft human amniotic membrane is regulated solely under section 361 of the Public Health Service Act. The purpose of the study is to see if this treatment works to accelerate the healing time of chronic wounds.

NCT ID: NCT02119754 Completed - Infection Clinical Trials

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

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

This is an open label study of subjects who have failed Protocol PGN-1300. 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) and have failed PGN-1300. Subjects must also provide informed consent and meet all other entry criteria to be enrolled and receive PluroGel PN.

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: NCT02087215 Recruiting - Diabetic Foot Ulcer Clinical Trials

Effect of Local Application of Boron on Diabetic Foot Ulcers

Start date: January 2014
Phase: Phase 1
Study type: Interventional

Boron as a naturally occurring element has some metabolic and inflammatory actions. The antibacterial activity against gram negative bacteria is also known. Boron deficiency is shown to be related with impaired wound bone healing in rats. Therefore, special wound care formulas containing boron may have some positive effect on wound healing of the patients with diabetic foot ulcers.

NCT ID: NCT02086955 Recruiting - Diabetic Foot Ulcer Clinical Trials

Outpatient Nurse Managed Counseling Program for Patients With Diabetic Foot Ulceration

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

The purpose of the study is to evaluate the effectiveness of a nurse led intervention for high risk patients with diabetic foot ulceration and/or amputation. The effectiveness is defined in two ways 1) as a reduction in complication rates (time till ulceration recurrence, new ulcerations, amputation or reamputation) and 2) as a reduction in hospital readmissions for foot-related complication (one year survival probability: failure = readmission for ulceration recurrence, new ulcerations, amputation or re-amputation).