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Diabetic Foot clinical trials

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NCT ID: NCT03312595 Completed - Diabetic Foot Ulcer Clinical Trials

Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU)

Start date: September 14, 2017
Phase: N/A
Study type: Interventional

The primary objective of this study is to determine the outcomes of patients who receive a certain type of skin substitute called RestrataTM Wound Matrix (Restrataâ„¢). Results of this study may be used to make decisions on whether to conduct additional studies on this particular wound matrix product. RestrataTM has been cleared by the Food and Drug Administration for use in certain types of ulcer treatments, including the type that will be part of this study (diabetic foot ulcers).

NCT ID: NCT03296436 Withdrawn - Diabetic Foot Ulcer Clinical Trials

A Pilot Study to Assess the Efficacy of NEOX® CORD 1K® in the Treatment of Complex Diabetic Wounds

Start date: January 2020
Phase: Early Phase 1
Study type: Interventional

Patients presenting to Johns Hopkins with a diabetic ulcer classified by the UT Grade 2 or 3 who meet all of the inclusion and none exclusion criteria and give their informed consent, will receive an application of NEOX CORD 1K in addition to standard of care procedures. Those patients will be seen in follow-up at weekly visits until the wound closes and epithelize, achieving complete closure. Subjects that do not achieve complete ulcer closure prior to or at the end of the 16 treatment weeks will exit the study.

NCT ID: NCT03282981 Completed - Clinical trials for Chronic Diabetic Foot Ulcers

Beta Adrenergic Antagonist for the Healing of Chronic DFU

BAART-DFU
Start date: June 14, 2018
Phase: Phase 3
Study type: Interventional

One in four Veterans is affected by diabetes and will develop a diabetic foot ulcer. Diabetic ulcers are very challenging to manage and are the most common cause of leg amputation. Many advanced treatments are expensive and difficult to use in the clinic or at home. Those newer therapies have shown little success in healing diabetic foot wounds. The investigators' laboratory and animal work has suggested that a safe medication, currently used as an eye drop for treatment of glaucoma, can heal these ulcers. The investigators are proposing to test this drop (timolol) directly on the surface of the foot ulcer to see if can improve healing faster than the current standard of care. To do this, the investigators propose a "randomized controlled trial" with two groups of patients with diabetic foot ulcers: one will receive standard of care with timolol while the other will receive standard of care with a gel (hydrogel, as placebo medicine).

NCT ID: NCT03280524 Completed - Diabetic Foot Clinical Trials

Reflexology and Quality of Life

Start date: January 2016
Phase: N/A
Study type: Interventional

This is a randomized, controlled and blind clinical trial with 60 type 2 diabetes patients divided into 2 groups of 30 patients each, Control Group (CG) and Treatment Group (TG). The TG will receive self-care guidelines with feet and 12 sessions of foot reflexology, while the CG will only receive the guideline.

NCT ID: NCT03276312 Completed - Diabetic Foot Clinical Trials

Autologous Micro-fragmented Adipose Tissue in the Treatment of Minor Amputations of Diabetic Foot

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

This is a randomized controlled monocentric study on 114 diabetic patients with the aim of evaluating the efficacy of the lipofilling with Lipogems® system in diabetic patients that are candidates for a minor amputation in the foot. In particular, it will be evaluated whether the lipofilling will be able to shorten the healing times and to reduce the number of major amputations, with consequent positive impact on the quality of life. Patients will be randomized to the treatment group with Lipogems® (local injection of autologous micro-fractured adipose tissue) or to the control group, thus, treatment according to standard clinical practice.

NCT ID: NCT03259217 Not yet recruiting - Clinical trials for Stem Cell Transplant

Clinical Application of Mesenchymal Stem Cells Seeded in Chitosan Scaffold for Diabetic Foot Ulcers

Start date: October 2017
Phase: Phase 1
Study type: Interventional

This study will assess the efficacy of application of stem cell in healing of chronic diabetic foot ulcer

NCT ID: NCT03254095 Completed - Diabetes Clinical Trials

Predictors of Skin Temperature, Plantar Pressure and Ulceration in Diabetic Foot Patients.

Start date: September 1, 2016
Phase:
Study type: Observational [Patient Registry]

Diabetes is a chronic disease with increasing prevalence worldwide with a high burden to individuals and the society and it is expected to be the 7th leading cause of death in 2030. Diabetes related complications manifest in many body parts, often in the foot, due to reduced blood flow and nerve damage, increasing the risk of ulcers and amputation. High plantar pressures during walking contribute to the development of foot ulcers and foot ulcer recurrence. Emerging studies also point skin temperature as another predictor of foot ulceration. However, the number of studies including prediction models of plantar pressure and skin temperature are scarce, especially in patients with confirmed diagnosis of diabetic foot and a history of foot ulcer. Factors like mobility, hardness of plantar soft tissue, foot deformities and other diabetes related characteristics have been related to plantar pressure measurements but not to foot skin temperature measurements, and the relation between skin temperature and plantar pressure has not been much explored in the literature. The role of these variables in the development of foot ulceration needs further attention, especially in patients with history of foot ulcers has they are at the highest risk to develop a foot ulcer. Therefore, the goal of this research is to determine which variables can be used to predict plantar pressure and skin temperature and which factors are associated with the development of foot ulcers in patients with established diagnosis of diabetic foot. The associations between skin temperature and plantar pressure will also be addressed.

NCT ID: NCT03248466 Recruiting - Diabetic Foot Ulcer Clinical Trials

PRG Combined With Autologous BMMSCs for Treatment of Diabetic Foot Ulcer

Start date: August 30, 2017
Phase: Early Phase 1
Study type: Interventional

To investigate the treatment effect between Traditional treatment and transplantation of autologous PRG combined with autologous BMMSCs for treatment of diabetic foot ulcer.

NCT ID: NCT03239457 Completed - Diabetic Foot Clinical Trials

Efficacy and Safety of Heberprot-P® in Patients With Advanced Diabetic Foot Ulcer in Dasman Diabetes Institute.

Start date: December 2015
Phase: N/A
Study type: Observational

The purpose of this study is to assess the efficacy and safety of the intralesional administration of Heberprot-P® (human recombinant epidermal growth factor) plus the standard treatment in patients with complex diabetic foot and risk of major amputation in Kuwait.

NCT ID: NCT03232333 Completed - Diabetic Foot Ulcer Clinical Trials

MIRODERM H2H DFU Study

H2H-DFU
Start date: July 21, 2017
Phase:
Study type: Observational

This study will assess the ability of MIRODERM to heal difficult diabetic foot ulcers within 12 weeks of treatment.