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Diabetic Foot clinical trials

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NCT ID: NCT02461641 Completed - Clinical trials for Foot Ulcer, Diabetic

NuShield/Affinity for the Treatment of Neuropathic Diabetic Foot Ulcers

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

This study was designed to determine the heal rate of diabetic foot ulcers at 4 weeks, and complete closure at 8 and 12 weeks of patients treated with either NuShield or Affinity compared to standard care alone.

NCT ID: NCT02452086 Completed - Diabetic Foot Ulcer Clinical Trials

Low Level Laser Therapy and Expression of VEGF, NO, VEGFR-2, HIF-1α in Diabetic Foot Ulcers

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

The purpose of this study is to examine the changes of factors including Vascular Endothelial Growth Factor(VEGF), VEGFReceptor-2, Nitric Oxide and hypoxia-inducible factor-1α (HIF-1α), measurements of oxygen saturation in peripheral blood and wound surface area and ankle-brachial index (ABI) in ischemic diabetic foot ulcers after Low Level Laser Therapy(LLLT).

NCT ID: NCT02451722 Completed - Clinical trials for Diabetes Mellitus Type 2

Evaluation of Pressure Distribution of Kyboot Shoes in Comparison to Other Foot Wear

Kyboot
Start date: May 2015
Phase: N/A
Study type: Interventional

Comparison and evaluation of pressure distribution, gait pattern, changes in the movement of the center of pressure, shock absorbing capabilities and comfort of wear using KyBoot shoes versus normal foot wear in diabetic and healthy subjects.

NCT ID: NCT02447172 Completed - Infection Clinical Trials

Study of a Topical Gentamicin-Collagen Sponge Along With Systemic Antibiotic in Infected Diabetic Foot Ulcers

COACT-2
Start date: June 2015
Phase: Phase 3
Study type: Interventional

This is a phase 3, randomized, controlled, blinded, multicenter study conducted in 3 parallel cohorts of diabetic patients with at least 1 infected foot ulcer. Patients will be randomized to receive 1 of 3 study treatments; systemic antibiotic therapy and standard ulcer care with either (A) daily application of a gentamicin-sponge, (B) daily application of a placebo-sponge or (C) no-sponge, in the ratio 2:1:1. Patients will be treated for approximately 28 days and return to the clinic weekly for safety and efficacy assessments. After completing treatment, patients will return to the clinic for scheduled follow-up visits approximately 10, 30, 60 and 90 days after treatment is stopped.

NCT ID: NCT02440282 Completed - Diabetic Foot Ulcer Clinical Trials

Comparison of Anesthetic Modalities on Hemodynamic Stability and Postoperative Pain in Diabetic Foot Patients Undergoing Minor Lower Extremity Amputation

Start date: January 2012
Phase: N/A
Study type: Observational

Diabetic foot ulcer is the most common cause of non traumatic lower extremity amputations (LEA) associated with diabetes. Traditionally general and spinal anesthesia were the preferred modality of anesthesia. The use of sciatic nerve block has recently gained popularity, however, without the supporting evidence of any benefits. This study was to evaluate the comparison of anesthesia modalities for hemodynamic stability and postoperative pain in diabetic foot patients undergoing minor LEA.

NCT ID: NCT02432859 Completed - Diabetic Foot Clinical Trials

Electrical Stimulation and Expression of VEGF, VEGFR-2, HIF and NO in the Diabetic Foot Ulcer

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

The purpose of this study is to determine whether electrical stimulation is effective in the expression of VEGF, VEGFR-2, HIF-1α and NO and healing in diabetic foot ulcer.

NCT ID: NCT02427802 Completed - Infection Clinical Trials

Study of a Topical Gentamicin-Collagen Sponge Along With Systemic Antibiotic in Infected Diabetic Foot Ulcers

COACT-1
Start date: May 2015
Phase: Phase 3
Study type: Interventional

This is a phase 3, randomized, controlled, blinded, multicenter study conducted in 3 parallel cohorts of diabetic patients with at least 1 infected foot ulcer. Patients will be randomized to receive 1 of 3 study treatments; systemic antibiotic therapy and standard ulcer care with either (A) daily application of a gentamicin-sponge, (B) daily application of a placebo-sponge or (C) no-sponge, in the ratio 2:1:1. Patients will be treated for approximately 28 days and return to the clinic weekly for safety and efficacy assessments. After completing treatment, patients will return to the clinic for scheduled follow-up visits approximately 10, 30, 60 and 90 days after treatment is stopped.

NCT ID: NCT02423850 Completed - Clinical trials for Diabetes Mellitus, Type 2

Three-dimensional Measurements of Diabetic Foot Ulcers

Start date: August 2015
Phase:
Study type: Observational

Diabetic foot ulcers constitute an increasing health problem in Denmark concurrent with an ageing population and an increase in diabetes prevalence. Diabetic foot ulcers belong to the most serious and costly complications. Several studies have found that the size and depth of the ulcer is one of the major etiologic factors for delayed healing. Wound measurement is important in the monitoring of the wound healing process. For the last decade different 3D (three-dimensional) techniques for measuring wounds have been proposed in order to measure wound volume, but none of the technologies have been widely used. A 3D Wound Assessment Monitor (WAM) camera has been developed, which is able to measure wound size in 3D and to assess wound characteristics. The investigators hypothesize that three-dimensional measurements of diabetic foot ulcers are feasible in the assessment of wound healing. A prospective cohort study is conducted in which newly admitted patients with a diabetic foot ulcer are included at the first visit at the multidisciplinary clinic. The patients are followed for one year or until complete wound healing, amputation or death. The four wound measurements: 2D area, 3D area, perimeter and volume are measured using the 3D-WAM camera with frequent intervals. Patient anthropometrics and wound data are collected during the study and correlated to the wound healing.

NCT ID: NCT02405767 Completed - Diabetic Foot Ulcer Clinical Trials

BioimPEDance of Diabetic Foot Ulcers

BIPPED
Start date: April 2015
Phase: N/A
Study type: Interventional

The BIPPED study seeks to determine whether wound healing, in particular diabetic foot ulcers, can be monitored using electrical bioimpedance analysis (BIA). BIA measures the resistance of biological tissue to the passage of a very small electric current applied with electrodes. Different types of tissue, due to cell structure, hydration and vascularization, have specific electrical characteristics. The BIPPED study aims to provide experimental data for the development of a BIA sensor for monitoring of wound healing in chronic wounds.

NCT ID: NCT02394886 Completed - Diabetic Foot Ulcer Clinical Trials

Safety of ALLO-ASC-DFU in the Patients With Diabetic Foot Ulcers

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

This is a phase I open-label study to evaluate the safety of ALLO-ASC-DFU in diabetic foot ulcers patients. ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide an new option in treating a diabetic foot ulcer.