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Diabetic Foot clinical trials

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NCT ID: NCT02587104 Completed - Clinical trials for Diabetic Foot Ulcers

dHACM In the Treatment of Diabetic Foot Ulcers

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

A single-centered, non-randomized study with approximately 20 subjects that will be seen for up to 12 weeks, each receiving the EpiFix plus standard of care. Safety and effectiveness will be monitored throughout the study.

NCT ID: NCT02581488 Completed - Diabetic Foot Clinical Trials

Use of Santyl in Diabetic Foot Ulcers

Start date: October 2015
Phase: Phase 4
Study type: Interventional

This study is designed to test the hypothesis that daily treatment of diabetic foot ulcers with an enzymatic debriding agent, SANTYL, for up to 6 weeks will result in more rapid decrease in ulcer area than diabetic foot ulcers treated with a topical treatment containing silver. After meeting study criteria, participants will be randomly assigned to apply SANTYL or a topical treatment containing silver to their to foot ulcer for up to 6 weeks. At the end of 6 weeks, participants will be followed for an additional 4 weeks to examine the outcome of the study treatment.

NCT ID: NCT02581098 Completed - Diabetes Mellitus Clinical Trials

miR-200b & miR-21 in Diabetic Wounds

Start date: August 2015
Phase:
Study type: Observational

This study aims to determine if elevated wound-edge endothelial miR-200b is a barrier to wound healing in diabetic patients and also to determine if ex vivo supplementation of miR-21 mimic and recombinant MFG-E8 resolve inflammation in wound macrophages isolated from NPWT sponges from diabetic wounds. This study will enroll 124 (60 in the miR-200b arm and 64 in the miR21 arm) Diabetic Wound patients who have wound tissue oxygenation adequate to support wound healing and will be in the study for 14 weeks that includes 4 study visits.

NCT ID: NCT02579070 Completed - Diabetic Foot Clinical Trials

Diabetic Foot Ulcer Prevention System (DFUPS) - Part 2

DFUPS
Start date: February 8, 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate whether regular measurement of skin foot temperature with a novel device (DFUPS) will prevent ulcer recurrence in diabetic patients at high risk of foot ulceration. It is planned to regularly measure the temperature of the feet of people with diabetes who have already had a foot ulcer which has subsequently healed. These measurements should allow the identification of hotspots on the foot and may be helpful when advising about ulcer risk and providing preventative treatment. It is hoped to find out whether the regular use of thermal images taken with the DFUPS device together with standard foot treatment may reduce the number of people with diabetes developing ulcers or even prevent foot ulcers.

NCT ID: NCT02577900 Completed - Diabetic Foot Clinical Trials

Diabetic Foot Ulcer Study on Topical Interventions

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

The purpose of this study is to determine whether nanocrystalline silver dressing, manuka honey dressing and conventional dressing are effective in the treatment of diabetic foot ulcer.

NCT ID: NCT02538705 Completed - Clinical trials for Ulcers Related to Diabetic Foot Syndrome

Safety and Efficacy Study of Neovasculgen (Pl-VEGF165) Gene Therapy in Patients With Diabetic Foot

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

The purpose of this study is to determine whether pl-vegf165 (Neovasculgen) is effective in the treatment of ulcers related to diabetic foot syndrome

NCT ID: NCT02501538 Completed - Clinical trials for Foot Ulcer, Diabetic

Continuous Diffusion of Oxygen (CDO) Treatment for Healing of Diabetic Foot Ulcers

EO2
Start date: June 2015
Phase: N/A
Study type: Interventional

This is a pilot study. Maximum 30 subjects with a diabetic foot ulcer (DFU) or surgical foot wound will be consented in order to have 20 eligible subjects who will be enrolled and completed the study. Study duration will be three weeks. Patients will be consented and undergo debridement as standard of care at day 0. Ankle-Brachial Index (ABI), Monofilament Sensory Test and Vibration Perception Threshold(VPT) test will be performed only at day 0. Tissue samples will be taken at this visit during standard of care wound debridement and these tissue samples of the wound would normally be removed as part of routine debridement. These tissue samples of the wound will be used for gene expression and bacterial analysis(research). The patient will then receive topical oxygen therapy using the Transcutaneous O2 device (research) with moist wound dressings for 21 days. Moist wound dressings are used as standard of care. Treatment will be initiated during Screening/Baseline visit(day 0) after routine wound debridement, and patient will receive instructions for home use of the device. The patient will be seen for routine wound debridement at days 7, 14, and 21 with a study window of 5 days., Digital photos of the wound, and vascular evaluations (Transcutaneous oxygen measurements and Hyperspectral imaging. will be performed at each study visit(research). Tissue samples will be taken during standard of care wound debridement at every study visit. Results of the data analysis from this project will be used to inform the design of a larger randomized clinical trial.

NCT ID: NCT02470806 Completed - Clinical trials for Diabetic Foot Ulcers

Single-Use Negative Pressure Wound Therapy System vs. Traditional Negative Pressure Wound Therapy System (tNPWT)

NPWT
Start date: July 2, 2015
Phase: N/A
Study type: Interventional

The aim of this study is to compare the clinical efficacy of two types of NPWT systems; the traditional negative pressure wound therapy (tNPWT) system and the single-use negative pressure wound therapy (PICO) system.

NCT ID: NCT02463500 Completed - Clinical trials for Diabetic Foot Ulcers

UT Southwestern Diabetic Foot Ulcers (DFU) and Osteomyelitis (DFO) Recruitment Database, Data and Tissue Repository

DFUDatabase
Start date: January 2015
Phase:
Study type: Observational [Patient Registry]

This will be a continuing, prospective study of diabetic foot ulcers and infections, risk factors and clinical outcomes and a limited data set conducted by the investigator through the establishment of a data and tissue repository in the uT Southwestern Department of Plastic Surgery. in addition, subjects consented for this research will be asked about inclusion in a recruitment database to be used in the recruitment of subjects for future research on diabetic foot complications. about 250 patients are seen for diabetic foot ulcers and infections each year.

NCT ID: NCT02463487 Completed - Clinical trials for Diabetic Foot Ulcers

Negative Pressure Wound Therapy as a Drug Delivery System

Start date: June 2, 2015
Phase: N/A
Study type: Interventional

The investigators plan a randomized clinical trial of 150 patients with infected diabetes-related lower extremity wounds to compare the clinical and economic effectiveness of negative pressure wound therapy with continuous irrigation and negative pressure wound therapy without irrigation.