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Diabetic Wound clinical trials

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NCT ID: NCT06153953 Not yet recruiting - Diabetic Wound Clinical Trials

A Comparative Study Between Vacuum Therapy Dressing and Conventional Dressing in Management of Diabetic Wounds

Start date: December 2023
Phase: N/A
Study type: Interventional

Diabetes is a global epidemic and a leading cause of death by disease. An estimated 366 million people worldwide had diabetes in 2011.(1).The incidence of diabetic foot ulcers (DFUs) and diabetic complications increases as the age increases.(2).Up to 25% of patients with diabetes will suffer from a foot ulcer during their lifetime. Ulceration is a pivotal factor in the causal pathway to infection and amputation.(3,4).Diabetic foot ulcers (DFUs) are the main cause of hospitalization in diabetic patients and they are considered a worldwide health problem. In recent years, the improvement in diabetes therapy and the reinforcement of guidelines have reduced the amputation rate.(5).The etiology of DFU is complex and rarely unifactorial. In general, foot ulcers are the cumulative result of repetitive trauma that wears a hole in the skin. The triad of neuropathy, foot deformity, and minor considers as the major contributing factors of ulcer development.(6).Vacuum therapy or Negative Pressure Wound Therapy is a technology uses a piece of foam in contact with the wound bed, covered by an occlusive dressing and placed under sub atmospheric pressure.(7).In other words NPWT is a non-invasive therapy system that uses controlled negative pressure using a vacuum device to promote wound healing by removing fluid from open wounds through a sealed dressing or a foam dressing connected to a collection container using sub-atmospheric pressure.(8).The system produces granular tissue that has a characteristic rough appearance. The device can decrease the depth and area of large diabetic foot wounds into a shallow, smaller wound.(8,9).NPWT was first proposed by Argenta and Morykwas in 1997. From then it has been approved as an effective modality of dressing in chronic wounds.(1).NPWT is a safe modality of dressing it has shown a few complications. Minor complications encountered in the vacuum-treated patients : erosion of adjacent tissue due to increased local pressure underneath the tubing ,mild reactions of the peri-wound area (i.e. maceration and eczema) , and sudden increase in body temperature.(10)

NCT ID: NCT06004219 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Peer Support for Patients With Diabetic Foot Ulcers

Start date: November 21, 2023
Phase: N/A
Study type: Interventional

The objective of the study is to develop a peer support program that helps improve ulcer care in patients with a diabetic foot ulcer (DFU).Diabetes, peripheral arterial disease (PAD), foot ulceration, and subsequent amputation are unevenly patterned in terms of racial/ethnicity, socioeconomic status, health insurance, and geographic area. The project will identify opportunities to reduce health disparities among economically marginalized patients regarding DFU outcomes.

NCT ID: NCT05850611 Recruiting - Clinical trials for Diabetic Foot Ulcers

The Effect of Combination Therapy of Oral MB and PRP-FG in Patients With Non-healing Diabetic Foot Ulcer

Start date: April 30, 2023
Phase: Early Phase 1
Study type: Interventional

The aim of this study is to evaluate the chance of non-healing diabetic foot ulcers repair by improving the condition of lack of oxygen or hypoxia in the wound area caused by diabetes using methylene blue along with the use of platelet-rich plasma-fibrin glue as an effective treatment for wound healing.

NCT ID: NCT05191758 Completed - Healing Wound Clinical Trials

Nutritional Regulation of Leukocyte Function

FPP Supplement
Start date: February 15, 2022
Phase: N/A
Study type: Interventional

The objective of the current study is to determine the dose at which Fermented Papaya Preparation ( FPP) is able to improve inducible respiratory burst outcomes in peripheral blood mononuclear cells (PBMC) and neutrophils of participants. Our investigators have reported that supplementation with standardized fermented papaya preparation (FPP) in mice improves dermal wound healing outcomes. Therefore, based on these observations, the investigators propose to study the dose at which FPP supplementation induces respiratory burst in blood-derived myeloid cells in healthy subjects.

NCT ID: NCT04591691 Recruiting - Diabetes Clinical Trials

C-myc Biomarker Study for Diabetic Foot Ulcers

Start date: October 14, 2020
Phase:
Study type: Observational

This is a multi-center observational cohort study of patients with diabetic foot ulcers (DFU) to develop and validate potential tissue-based biomarkers that predict complete wound healing. Eligible and consented participants will begin standard of care treatment after collection of tissue specimens from the wound's edge. An additional tissue specimen is collected at 4 weeks if clinically indicated. Tissues will be tested for c-myc and phosphorylated glucocorticoid receptor (p-GR) levels using validated protocols at a central laboratory. Participants will be followed weekly for up to 12 weeks or until complete wound healing (whichever occurs first). One final assessment 2 weeks after complete wound healing will occur to confirm healing.

NCT ID: NCT04558775 Completed - Diabetes Clinical Trials

TEWL Biomarker Study for Diabetic Foot Ulcer Recurrence

TEWL
Start date: June 17, 2020
Phase:
Study type: Observational

This is a multicenter study of patients with diabetic foot ulcers (DFU) to develop and validate potential tissue-based biomarkers that predict DFU wound recurrence. Trans-epidermal water loss (TEWL) will be measured on the closed wound site and a location similar to the wound site (reference site). Participants will be enrolled within two weeks after closure of their DFU. Complete wound healing will be verified at a second visit two weeks later and this visit will start the 16 week timeline where participants will be followed weekly by phone until the earliest of DFU wound recurrence or 16 weeks. Participants who experience a DFU wound recurrence and a subset of participants who do not experience a DFU wound recurrence by week 16 will be asked to attend one final visit.

NCT ID: NCT04405765 Completed - Diabetic Wound Clinical Trials

Cryopreserved vs. Lyopreserved Stravix as an Adjunct to NPWT in the Treatment of Complex Wounds

Start date: June 22, 2021
Phase: Phase 4
Study type: Interventional

This study is a prospective, 2-arm parallel assignment, randomized clinical trial to compare lyopreserved vs cryopreserved Stravix as an adjunct therapy to NPWT.

NCT ID: NCT04405050 Withdrawn - Diabetic Wound Clinical Trials

RCT to Compare Restrata and NPWT to Heal Complex DFUs

Start date: June 2021
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the efficacy of Restrata compared to Negative Pressure Wound Therapy (NPWT) to heal complex diabetic foot wounds.

NCT ID: NCT04315909 Recruiting - Clinical trials for Diabetic Foot Ulcers

The Effect of Platelet-Rich Plasma-Fibrin Glue in Combination With Vitamin E and C for Treatment of Non-healing Diabetic Foot Ulcers

Start date: August 28, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

The aim of this study is to evaluates the chance of non-healing Diabetic Foot Ulcers repair by reducing oxidative stress caused by diabetes by taking vitamin E and C supplements along with the use of Platelet-Rich Plasma-Fibrin Glue as an effective treatment for wound healing.