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Foot Ulcer clinical trials

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NCT ID: NCT03675269 Withdrawn - Diabetic Foot Ulcer Clinical Trials

Adjunctive Hyperbaric Oxygen Therapy (HBOT) for Lower Extermity Diabetic Ulcer:

Start date: September 5, 2018
Phase: N/A
Study type: Interventional

Diabetic foot ulcers are associated with high risk of amputation. About 50% of patients undergoing non-traumatic lower limb amputations are diabetics5. The 5-year amputation rate is estimated to be 19% with a mean time to amputation 58 months since the onset of an diabetic foot ulcer6.Because infection and tissue hypoxia are the major contributing factors for non-healing diabetic foot ulcers, hyperbaric oxygen therapy (HBO) carries a potential benefit for treating these problematic wounds that do not respond to standard therapy. The role of oxygen in the wound healing cascade and subsequent combatting action against bacterial invasion, especially anaerobes, is well documented.14 Delayed or arrested healing and the development of infection is a direct result from decreased perfusion and poor oxygenation of tissue.15 The presence of wound hypoxia is an major etiological pathway in the development of chronic non-healing diabetic foot ulcers

NCT ID: NCT03670225 Completed - Diabetic Foot Ulcer Clinical Trials

Evaluating Clinical Acceptance of a NPWT Wound Care System

Start date: October 16, 2018
Phase: N/A
Study type: Interventional

Determine if use of the Medela Invia Motion NPWT system supports acceptable progress towards the goal of therapy when treating patients with a variety of wound types during the evaluation period.

NCT ID: NCT03662997 Completed - Diabetic Foot Ulcer Clinical Trials

Clinical Study to Compare 3 Multi-Layered Foam Dressings for the Management of Chronic Wounds

Start date: March 19, 2019
Phase: N/A
Study type: Interventional

A prospective, randomized, controlled clinical trial (RCT) using a cross-over (repeated measures) design to evaluate safety and efficacy of three foam wound dressings in the local management of chronic wounds.

NCT ID: NCT03654989 Terminated - Diabetic Foot Ulcer Clinical Trials

Iontophoresis of Treprostinil to Enhance Wound Healing in Diabetic Foot Skin Ulcers

InTREPiD
Start date: January 28, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Assess the effect of iontophoresis of treprostinil on wound closure over 12 weeks, in patients with DFU. In the present study the investigators aim at establishing the proof-of-concept of iontophoresis of treprostinil as a potential treatment of diabetic foot ulcers in humans. The main hypothesis is that in patients with DFUs, the pharmacodynamic effect of a PGI2 analogue potentiates the effect of low-intensity current on microvascular function, tissue oxygenation and healing.

NCT ID: NCT03640988 Terminated - Diabetic Foot Ulcer Clinical Trials

The Effects of High Energy Acoustic Shock Wave Therapy on Local Skin Perfusion and DFUs

Start date: April 25, 2019
Phase: N/A
Study type: Interventional

This is an observational, single-arm, on-label study. This clinical study will be conducted at up to 2 sites with a total of 10 subjects per site. All subjects will receive standard of care treatment which includes DFU treatments with the dermaPACE device.

NCT ID: NCT03626623 Terminated - Clinical trials for Diabetes Mellitus, Type 2

Diabetic Foot Ulcer Study Comparing Cytal Wound Matrix 1-Layer to Standard of Care

Start date: May 21, 2019
Phase: N/A
Study type: Interventional

This is a two-armed randomized controlled trial (RCT) primarily aimed at determining if application of Cytal Wound Matrix 1-Layer intervention to diabetic foot ulcers shows improved wound closure rates when compared to standard care intervention.

NCT ID: NCT03624023 Completed - Diabetic Foot Ulcer Clinical Trials

TWB-103 for Treating Lower Limb Ulcers on Patients With DM

Start date: December 19, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Primary Objective: To assess the safety profile of TWB-103 administered to subjects with diabetic lower limb ulcers Secondary Objective: To explore the efficacy of TWB-103 administered to subjects with diabetic lower limb ulcers

NCT ID: NCT03615755 Completed - Diabetic Foot Ulcer Clinical Trials

Short Duration Hyperbaric Oxygen Therapy to Improve HbA1c, Leukocyte, and Serum Creatinine

Start date: December 27, 2016
Phase: N/A
Study type: Interventional

The investigators want to evaluate the short duration HBOT can improve glycohemoglobin (HbA1c) levels, leukocyte count, and serum creatinine levels in patients with DFU (diabetic foot ulcer) Wagner 3-4.

NCT ID: NCT03583593 Completed - Clinical trials for Diabetes Mellitus, Type 2

Evaluation of DIAMEL® Combined With Insulin in Diabetic Foot Ulcer

Start date: May 23, 2014
Phase: Phase 2
Study type: Interventional

Diabetic foot syndrome is one of the most frequent complications in type 2 diabetic patients. The present work is carried out with the objective of evaluating the use of DIamel combined with insulin in diabetic foot ulcers. Method. Phase II clinical trial. A study group was created that receives the active product and another control group that receives a placebo. Double-blind study with a monthly follow-up for the first 6 months and then quarterly until the end of 1 year. Complementary tests are performed every 6 months to evaluate metabolic, lipid and renal function control.

NCT ID: NCT03547635 Completed - Diabetic Foot Ulcer Clinical Trials

AMNIOEXCEL® Plus vs A Marketed Comparator vs SOC in the Management of Diabetic Foot Ulcers

Start date: May 3, 2018
Phase: N/A
Study type: Interventional

This is a multicenter, randomized, parallel-group study comparing the outcomes associated with the use of AMNIOEXCEL Plus Placental Allograft Membrane, a marketed comparator and SOC alone in the management of diabetic foot ulcers (DFUs).