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Foot Ulcer clinical trials

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NCT ID: NCT02631512 Completed - Clinical trials for Diabetic Foot Ulcers

Evaluation of Woulgan in Diabetic Foot Ulcer

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

The aim of the current study is to support the performance and safety of Woulgan® in the treatment of diabetic foot ulcer in comparison with the commercially available hydrogel Intrasite. Healing and untoward medical events to be evaluated.

NCT ID: NCT02626156 Completed - Diabetic Foot Clinical Trials

Cooling Leg and Foot Ulcer Skin Post Healing to Prevent Ulcer Recurrence

MUSTCOOL
Start date: June 1, 2015
Phase: Phase 2
Study type: Interventional

The goal of this study is to test MUSTCOOL, a home-based self-monitoring and self-management ulcer prevention intervention for patients with newly healed chronic venous leg and diabetic foot ulcers. Almost 90% of ulcers recur within 3 months of healing. During the six-month randomized clinic trial, skin temperature will be monitored daily, a maintenance dose of cooling gel pack or placebo will be applied three times weekly to the affected skin, and a bolus dose of cooling will be applied for 5 consecutive days if skin temperature becomes elevated. Outcomes on the incidence of leg ulcer recurrence, pain, physical activity and quality of life will be measured.

NCT ID: NCT02619877 Completed - Diabetic Foot Ulcer Clinical Trials

Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Foot Ulcers

Start date: October 2015
Phase: Phase 2
Study type: Interventional

This is a phase II single-blinded study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Diabetic Foot Ulcer, compared to standard therapy.

NCT ID: NCT02589210 Completed - Clinical trials for Diabetic Foot Ulcers

dHACM Mesh In the Treatment of Diabetic Foot Ulcers

Start date: May 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 mesh plus standard of care. Safety and effectiveness will be monitored throughout the study.

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: NCT02586519 Terminated - Diabetes Clinical Trials

Pressure-Sensing Insoles in the Neuropathic Ulcer Treatment Pathway

PINUP
Start date: June 2016
Phase: N/A
Study type: Interventional

Diabetic foot ulceration (DFU) is a common complication with a 25% lifetime risk in patients with diabetes. While most of these ulcers can be treated successfully on an outpatient basis, some will persist and become infected. Nearly one fifth of patients with lower-extremity diabetic ulcers will require amputation of the affected limb, resulting in staggering costs for both the patient and the healthcare system. Therapies that promote rapid and complete healing and reduce the need for expensive surgical procedures impact these costs substantially. The standard of care for the treatment of diabetic foot ulcers is the removable cast walker (RCW). RCW use has demonstrated plantar pressure reduction yet is typically perceived as having compliance issues due to its removable nature. In addressing this limitation, a modified version of the RCW has been developed by wrapping it in a layer of cohesive or plaster bandage. This technique has been termed the "instant" total contact cast (iTCC) derived from the seldom-used, gold standard treatment, the total contact cast (TCC). While ease of application and potential clinical equivalence are clear benefits, the iTCC carries disadvantages on account of its irremovability. For example, frequent dressing changes impractical, yet may be necessary for complex wound care. The goal of this research is to continue inquiry and innovation in this most basic aspect of care, whilst addressing the limitations of past research and failures in this domain. The investigators propose examining the capability of the SurroSense Rx® smart insole and smartwatch system (Orpyx Medical Technologies Inc., Calgary AB) in managing and monitoring adherence to plantar pressure offloading through alert-based feedback. The insoles are embedded with pressure sensors, which wirelessly communicate with a smartwatch that provides feedback on modifying activity or pressure profile over time. This smartwatch transmits audio, visual, and tactile notifications when excessive pressure-time thresholds under plantar regions of interest have been met. This feedback allows patients to be educated on their plantar pressure, and engages them and their caregivers to manage adherence to offloading. The investigators also propose comparing the healing rates of active neuropathic ulcers using RCWs coupled with the SurroSense Rx® smart insole system to assess whether adjunctive use of the two interventions improves the efficiency of neuropathic ulcer treatment.

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.